Steam Sterilizers

A879
MANUAL INSTRUCTION

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STEAM STERILIZER 0044
NAMWIWAT ENGINEERING (1992) CO., LTD.
999/5 Moo 9 Prachauthit-Khusang Rd.,
Naiklongbangplakod, Phrasamutjeydee,
Samutprakarn, 10290,
THAILAND

OBELIS S.A
Bd. General Wahis, 53
1030 Brussels,
BELGIUM

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3 of 39 M-A8P Rev.01
Contents
Introduction 5
Safety Instructions 6
Description of the sterilizer 9
Technical Data 10
Technical Description 13
Installation Instruction 16
Function and Program Description 18
Operating the Sterilizer 22
Routine Operation 26
Alarm- and Error Messages 33
Care, Maintenance and Inspection Schedules 35

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Introduction

All our products are developed, manufactured and tested within a certified and monitored Quality
Management System acc. to EN ISO 9001. Our devices for sterilization and disinfection fulfill the basic
requirements of all applicable EC-guidelines. This is documented by a respective Declaration of Conformity
and the applied CE-mark. Therefore, the products apply to the currently valid product- and safety
standards. Thus it is ensured that they can be installed and operated for their intended use without
endangering the user or other persons, provided this takes place strictly according to the instructions of this
instruction manual. The appendix of this instruction manual contains certificate of warranty. There,
the relevant clauses and conditions are fixed in detail in accordance with the legal regulations.

Our warranty promises are based on the proven quality of our products and their workmanship, as well as
upon a close customer service net in our marketing department. A list of our customer service places is
added at the end of this instruction manual.

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Safety Instructions
This Instruction Manual gives the user information about a device which may imply hazards due to electric
voltage and currents as well as because of mechanical, thermal and in some cases chemical operations.
Physical injury or property damage may result.

For this reason the following hazard symbols, instructions and warnings must always be observed!

Knowledge of the Safety Instruction in this Instruction Manual is a mandatory part during instruction and
training of all users. We especially refer to the warnings in chapter 2.4, because - as a result of the risk
analysis - they refer to possible endangerments which cannot be reduced by technical measurements
alone.

The operator of the devices is responsible for proper instruction/training of all users and e. g. yearly
repetition of the training.

Safety Indications
♦ The unit/the system may be applied only for the intended use which is determined in the
designation and in the description.
♦ Operation of the unit must meticulously adhere to the information in the Instruction Manual.
Improper use may cause physical injury or property damage.
♦ Read this Instruction Manual carefully before beginning installation or assembly work or operation
of the unit
♦ Preparatory steps for operating the unit may be carried out only by the user or specially trained
personnel, respectively.
♦ Be careful never to put the device into operation if it is clearly or presumably defective or
damaged
♦ Maintenance and repair work shall be carried out by qualified and trained personnel only who
carefully observe
● this Operating Instruction
● all other guide books for putting the unit into operation
● currently applicable national/regional regulations (safety/accident prevention).
♦ The user must ensure adherence to the service intervals. When external maintenance is carried out,
care must be taken that it is carried out only by the manufacturer or authorized persons.
♦ When internal maintenance is carried out by the user, adherence to the maintenance regulations
must be ensured by taking suitable safety precautions.

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Hazard Symbols
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.

Emergency-Stop! Identification mark of the emergency-stop switch.

Caution! Hot surfaces, danger of burns!

Please wear protective gloves.

Caution! Danger of getting jammed or crushed!

General Remarks
♦ This Operating Instruction is the basis for training the user; it communicates knowledge which is
required for the use and upkeep of the unit and the system as a whole.

Instructions for using this Operating Instruction

This operating instruction gives the user comprehensive information about all relevant aspects regarding
application of the unit and/or the system as a whole. The individual main sections are self-contained and
shall permit a large understanding even without deeper knowledge of the other sections. Thus it is not
possible to avoid frequent references to these other sections or if necessary to repeat texts in different
sections.

Knowledge of the Safety Instructions is a mandatory part during instruction and training of all users. We
especially refer to the Warnings chapter following, because - as a result of the risk analysis - they refer to
possible endangerments which cannot be reduced by technical measurements alone.

Function and program description describes the provided programs and their significant Process
Parameters and Application Areas.

Operating sequences explains in detail all standard and optional Operating Functions of the display- and
operating units. Although the usage of menu-structures and soft keys is made to make the operation mostly
self-explaining, the content of this chapter is important and helpful for a secure and experienced
application of the system as well as full utilization of the available possibilities.

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Routine Operation gives the user an important complete description of the procedures and processes in
daily routine. This includes the preparation of the device and the sterilization material, the sterilization
procedure and it´s professional documentation.

Alarm- and Error Messages describes the messages and the reaction of the device in case of Failures.

Care, Maintenance and Inspection Schedules contains instructions for preventive technical
Maintenance, including daily care and upkeep by the user.

The Annex contains technical Detail Information and detailed technical and general references and
descriptions, that are helpful in special cases or for training purposes.

♦ The Operating Instruction accompanies the unit, describes it and regulates not only assembly and first
use of the unit but also its care, maintenance, and inspection schedules, including tests of function and
repair work as well as storage and transport.

♦ This Instruction Manual also contains important instructions which must be given special attention.
They are designated with the words „CAUTION“, „ATTENTION“, „NOTE“ or „IMPORTANT“.

CAUTION: Designates working or operating procedures which shall be followed exactly in order to exclude
endangerment of persons. This also includes information on special risks while using the unit.

ATTENTION!
Refers to working and operating procedures which shall be followed exactly in order to avoid damage to
the unit or its destruction. This also applies to work procedures which must be carried out regularly
after unusual demands are made on the unit or in case of unusual types of operation.

NOTE, IMPORTANT: Applies to application-related technical requirements to which the user must pay
particular attention.

The text contains references to the illustrations and position numbers therein. These numbers are in
parentheses, e.g. (3/5) means Figure 3, Position No. 5.

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Description of the Sterilizer
Intended Use
The steam sterilizers of the Series A8 are used for reprocessing treatment and sterilization goods supply in
health care facilities, for sterilization of medical products, especially of surgical, dental and otherwise
medically used instruments (metal load), rubber articles and textiles at 121°C or 134°C.

The sterilizer is designed for stationary use.

It is not allowed to sterilize liquids, unless the sterilizer is specially designed and equipped with respective
Programs and functions. No flammable material can be treated.

Description
The Sterilizer Series A8 are equipped with a cylinder-section chamber, whose internal
dimension, and therefore capacity, varies according to the particular model. The sterilizers may have one doors , and have
their own steam generator. The hinged door is opened from front side or vice versa and the door locking system are
operated manual through the door switch.

The sterilizers are centrally controlled by a programmable automaton with both digital and analog inputs
and outputs. They are also provided with display and printout facilities allowing the operator or
maintenance technician to receive information about the status of the machine and the progress of the
program cycle.

They are equipped with a digital printer. Each sterilizer is provided with pre-set sterilization and test
programs. There is also the option of a supplementary program as described below. The programs your
sterilizer is provided with are specified in the corresponding Technical Factsheet, that you will find at the
beginning of this manual.

The code used for designating the different models in the table is illustrated in the following example:

Model: A879 – 50 L
Series

Indicates chamber capacity

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Sterilizer Specification
MODEL A879

Chamber Dimension (cm.)

Ø 43

Depth 56

External Dimension (cm.)

Height 153

Width 70
Depth 80

Weight 251 kg

TECHNICAL
A879
PARAMETERS

Pressure Vessel
Chamber Volume (approx.) 50L

Permissible Operating
Overpressure
Chamber -1/3 bar
Jacket 0/3 bar
Boiler 3.3 bar
Others

Steam Consumption per Approx. 30 kg

Charge
Electrical Steam Generator 4.5 kW
Ambient Conditions
Temperature Range (+10 ~ +40˚C for operation ; +25 ~ +55 ˚C for storage & transportation)
Humidity ≤80%RH
Power Supply Fluctuation ±10%
Range

Overvoltage Category II
Pollution Degree 2

Electro magnetically compatibility acc. to EN 61326-1

Mean sound power level: less than 90dB(A)

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Media Supply and Connections
MODEL A879

Power Supply 220V ~ 50 Hz

Nominal Power 4.5 kW
Steam Supply
Pressure 2.5-3.0 bar
Flow Rate 2.6 kg/min
Steam quality according to EN 285
DS-Water Supply
Pressure 2.5-4.0 bar
Flow Rate 45-50 L/hr

NOTE:
The steam quality and the quality of the condensate and/or the water quality of the feeding water for the
respective steam generator must comply with certain minimum requirements, so that the used steam is
suitable for sterilization processes. These quality requirements are specified in the EN 285.

Table 1: Permissible amount of contaminations in the condensate and in the feed water for
feeding the respective steam generator.

Condensate Feeding Water

Evaporation Residues - ≤10mg/l
Silicone Dioxide SiO2 ≤0,1mg/l ≤1mg/l
Iron ≤0,1mg/l ≤0,2mg/l
Cadmium ≤0,005mg/l ≤0,005mg/l
Lead ≤0,05mg/l ≤0,05mg/l
Residues of heavy metals ≤0,1mg/l ≤0,1mg/l
Chlorides ≤0,1mg/l ≤0,2mg/l
Phosphates ≤0,1mg/l ≤0,5mg/l
Conductivity at 25°C ≤3µS/cm ≤5µS/cm
pH-Value 5-7 5-7
Hardness ≤0,02mmol/l ≤0,02mmol/l
Appearance colorless, clear, without sediment colorless, clear, without sediment

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NOTE:
In order to ensure the required quality of the feeding water, we recommend to install a suitable water
treatment device in the feed line of the sterilizer.

According to EN 285 the amount of non-condensable gases in the feeding water may not exceed 3.5 Vol%
in order to ensure proper sterilization operation.

Cold Water Supply

2,5 to 4 bar, max. 15°C; drinking water quality.
Hardness max. 15°dH (Recommendation acc. to EN285, 0,7 - 2,0 mmol/L).
Used as pump operating water and in the cooling circuits.
For further details please see the installation drawing and the respective data sheet.

NOTE:
At water temperatures >15°C (up to max. 22°C) fresh water consumption and process times increase
particularly with larger loads. Higher degrees of hardness result in increased levels of deposits of mineral
salts in the cooling circuits and pumps.

Waste Water and Condensate Drain

Collecting pipe DN100; temperature approx. 80°C, temporarily up to max. 100°C

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Te c h n i c a l D e s c r i p t i o n

1. Manometer, chamber pressure 8. Safety valves, Jacket

2. Manometer, jacket pressure 9. “Cycle-in-Progress” Indication
3. Main Switch 10. “End-of-Cycle” Indication
4. Sterilizer Door Loading Side 11. Level Indicator Steam Generator
5. Printer Paper Compartment 12. Steam release valve
6. Manometer, steam generator pressure 13. Drain valve
7. Water Feeding Indication

Control Elements on the Front Panels

The following text details the individual components and control elements on the front of the units that
control and operate the sterilizer. For this purpose, please see Fig. 6.1 and Fig. 6.2, which show each
individual element. Each of them is designated by a number corresponding to the end-numbers of the
subsequent sub-headings. „SA“ means „Sterile Area“ (also called „unloading side“), „NSA“ stands for „Non-
Sterile Area“ (also called „loading side“).

The following manometers can be optionally installed into the front of the sterilizer:
Manometer, chamber pressure range -1to+3 bar
Manometer, jacket pressure range -1to+3 bar
Manometer, steam generator pressure range -1to+3 bar

Mains switch is used to connect the unit with the electric power supply or disconnect it again. This switch
also turns on the electric power supply of the steam generator (if one is installed).

Display and Control Unit (NSA)

Control of the unit as well as the selection and start of programs takes place by means of a compact,
menu-operated touch-pad (/touch-screen, optional) control unit (6.1/4) which is installed in the front panel
. It also displays the present operational status, gives information on program
selection and processing stages, includes an actual value display of pressure and temperature, and shows
alarm signals in clear text.

Sterilizer Door
The sterilizer door is opened horizontally from front.

Printer Paper Compartment (NSA)

The printer paper can be kept in this compartment (6.1/4) on the manual rolling device until it is removed
for archiving.
A processing and data printer (6.1/3) is installed in the front of the unit for displaying and registering
process-specific data.

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The following information is printed out in plain text:
• Date
• Program name
• Total cycles (total batches)
• Time at program start
• Pressure-and temperature indication with time
• Time end of program
• Operating time (process duration)
• Alarm signals and information regarding the cause of the failure

Water Feeding Indication

The red lamp indication on the lower front part is on in order to indicate water feeding into the steam
generator.

Safety valves, Jacket

The valves equipped on top of the sterilizer are automatically released for safety reasons. In addition the
valves enable the manual release of jacket pressure for all users in case of emergency shutdown.

Level Indicator Steam Generator

The device is equipped with its own steam supply, a level indicator for the feed water of the steam
generator is located behind this opening in the front door. The water level is visible directly through this
plastic tube.

Steam release valve

The valve is used in releasing of sterilizing media before the daily sterilizer shutdown.

Drain valve
The valve is used before the daily shutdown to drain circulating water for steam generating.

CAUTION!
Prior to entering the inside of the sterilization chamber, (e. g. for cleaning purposes) the emergency stop
switch must be activated.

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 Front View

15

14

Back View

1. Manometer, chamber pressure

2. Manometer, jacket pressure
13 3. Buzzer
4. Display and Control Unit (Microprocessor)
5. Main Switch
6. Cover for Loading Side
7. Air Inlet Valve
8. Handle for lock door
9. Level Indicator Steam Generator
10. Drain valve
11. Safety valves
12. Water feeding indicator
13. Draining Valve
14. Filling water funnel
15. Steam outlet pipe from water circulate tank

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Installation Instruction
For safety reasons, the installation of the unit and the supply means as well as first use of the unit may be
carried out only by specially trained personnel. Local or national regulations concerning workers safety and
health may require, before initial start-up, an approval test to be performed by an expert from an
accredited body.

Transportation
The machine has several elements to make transport and unloading easy:
1. Use a fork-lift truck to transport the assembled machine on a wooden pallet.
2. Before placing the machine where it is going to be installed, remove the screws that are fastening
the sterilizer to the wooden pallet.
3. Once the machine has been installed where it is going to be used, it should be levelled with the aid
of the four adjustable feet, and left it at the height indicated in the installation drawing.
4. If you ever need to move the machine, use the same means and follow the same instructions as
for installing it.

Installation
The location and accessibility of the supply media and the drain pipe must be taken into account when
selecting the place of installation for the sterilizers. The device is so designed that there is no
inconvenience from exhaust steam.

Media supply and drain has to be assured by the user. Especially proper water quality for internal steam
production or proper quality of steam supply from external source is important. To avoid faulty operation
adequate lighting conditions at installation location are necessary. Please care for national regulations.
For safety reasons, the installation of the unit and the supply means as well as first use of the unit may be
carried out only by specially trained personnel. Local or national regulations concerning workers safety and
health may require, before initial start-up, an approval test to be performed by an expert from an
accredited body.

During device operation waste heat is given off continuously to the ambient air, particularly above the unit.
This must be carried off by means of a suitable room air conditioning / hot air exhaust system.

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Function - and Program Description

Function Principle and Application Area

The Large-Steam-Sterilizers of NAMWIWAT Series A8 sterilize by means of pressurized, flowing saturated
steam and function according to the fractionated vacuum process. The sterilization chamber and the jacket
are heated by means of saturated steam which comes either from the on-site steam supply or from an
integrated steam generator.

The steam sterilizers of the Series A8 are used for reprocessing treatment and sterilization goods supply in
health care facilities, for sterilization of medical products, especially of surgical, dental and otherwise
medically used instruments (metal load), rubber articles and textiles (porous load) at 121°C or 134°C.

The sterilization system is intended for stationary use.

The sterilizer is equipped with several programs. These programs, their respective processes and
parameters as well as the sterilizable material and specific application areas are described below.

Here, a process is defined as a sequence of process steps, which are implemented by the sterilizer from
program start to program end. Processes are regulated by parameters. The most important parameters of
the here available processes are pressure, temperature and time. Even if the sterilization processes are
performed according to the same procedure (e. g. fractionated vacuum process), the programs, which are
optimized for their respective applications, differ regarding the number and switch points of the
fractionating steps, as well as sterilization temperature, sterilization time and drying time.

It is not allowed to sterilize liquids, unless the sterilizer is specially designed and equipped with respective
programs and functions. No flammable material can be treated.

CAUTION!
Do not try to sterilize other materials than described below in your sterilizer. Clean and dry
the sterilization material thoroughly prior to sterilizing.

ATTENTION!
Never put flammable or explosive materials into the sterilization chamber.

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Location / Area for installation
1. Location to place machine:

1.1 The machine must has space for maintenance at least ½ meter for each side. Don’t put

machine close to the wall and avoid placing machine near flammable items.

1.2 Make sure nothing blocking the machine door. Must be easy for operator to

load/unload the instrument packages.

2. Water Connection:

Feeding water: No need to connect feeding water. The operator will only need to refill

water (Distilled water) into water funnel.

Draining: Use ½” steel pipe to connect into tank drain valve

3. Power connection:

Machine requires: 1 phase,220V, 50 Hz

Electrical current: 21 A

Electrical Power: 4.5 Kw

Note

Must always connect grounding

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Program Description

Test Programs
These programs enable the user to examine certain sub functions of the sterilizer or the
sterilization processes. They are used either as (daily) routine test, or if necessary, i.e. if there
are certain reference points for a malfunctioning.

Since these programs are not sterilization programs, they are specified in a special program
selection and display side.

CAUTION!
Test programs are no sterilization programs! Possibly inserted sterilization material has to be
regarded as UNSTERILE after the end of the program!

Vacuum Test
The Vacuum Leakage Test is used to test the leak-tightness of the sterilization chamber. It is
used whenever there are indications that a leak is present, e.g. when there is damage to the
seal, after the seal has been replaced, or in case of a technical defect. Failure to pass the Bowie
Dick Test can also indicate that the system has a leak.

The vacuum test hast to be performed with a preheated chamber. The pressure curve of the
Vacuum Leakage Test is shown in the following figure.

Bowie Dick – Test

The Bowie & Dick Test (B-D Test) is designed to serve as a daily routine test for checking the performance
of the system with regard to adequate ventilation and steam penetration of a textile test load (see also
chapter 10.1). The pressure curve of the B-D Tests corresponds to that of normal sterilization programs
(see below), with the following parameters:

Holding Temperature 134°C Holding Time: 4 Min

Fractionating Steps: 4+3 Drying Time: 5 Min

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Sterilization Programs
The following illustration shows the course of a sterilization process schematically.

The most important program parameters are indicated in the above figure: With program start a
sterilization cycle proceeds as follows:

a) First steam is fed into the chamber, this steam mixes with the air in the chamber and begins to heat the
material to be sterilized, then the vacuum pump sucks the air from the chamber and evacuates the
chamber (first vacuum stage).

b) Steam is then fed into the chamber again.

c) The vacuum pump sucks the steam-air mixture from the chamber and evacuates the chamber(first
vacuum stage).

d) Steam is fed again into the chamber (second pressure increase) it further expels residual air from the
chamber and heats the sterilization material.

e) The chamber is again evacuated and the process described above under b) and c) can be repeated
several times depending on the program.

f) The final pressure rise takes place until the standard pressure is reached. The standard pressure results
from the steam pressure curve of the water for the nominal sterilization temperature (saturated steam
conditions).

g) The sterilizing phase, saturated steam exposure begins when the standard pressure and the sterilization
temperature are reached.

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h) At the end of sterilization, the drying phase - a pressure reduction takes place.

i) At the end of the drying phase the sterilization chamber is ventilated (phase 8). This is acoustically
announced by a signal tone and optically by the LCD display (Option).

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Operating the Sterilizer
Operating-Unit (Non-Sterile Area)
Switching the Sterilizer on

Switch on the main breaker

Push the main switch to POWER “ON”, the sterilizer will fill the steam generator. The step of preheating
starts when the water is filled up to the determined level.

Sterilizer Door Control

CAUTION!
When doing loading and unloading after cycle complete, it is possible that the door leaf and the chamber are heated. Do not
touch these surfaces, danger of burns!

Close the door by pushing it against the edge of the pressure vessel then turn the
door to “LOCKED”, The sterilizer’s door is now locked and sealed completely.

For Double door model;

A door can only be opened or closed if the unit has been supplied with the required media and is switched
on and any process running is terminated properly. The sterilizer doors are counter-locking for safety reasons,
so that both doors can never be open at the same time. For this reason
certain conditions must be fulfilled in order to open the doors.
If necessary the door can be opened and closed repeatedly as long as the door on the loading side (NSD)
remains closed.

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 Select Sterilizing/Test Program Display

Wait until the boiler pressure rise up above 30 PSI, then select the sterilizing/test program by pressing
 or
The program to be selected is shown in black bar in contrast to the others. To select the program, press on
SET button once.

Starting a process, and therefore steam injection into the chamber, is not possible when the door is open.
This prevents injuries which might be caused by the discharge of steam.

No chamber door can be opened as long as chamber pressure is above 0.2 bar (overpressure) or a
program is running.

If a door is inadvertently left open or unlocked or the pressure in the door seal groove is too low while a
process is running, the process is halted and the supply of steam to the chamber is interrupted.

It is not possible to open a door as long as the other door is already open or the command to open has
been given.

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User Identifying Display

After pressing SET button, the USER ID display would show as below.

You can put 01-99 to identify the user, then again press SET once.

Program Start

The sterilizing/test program will start with a display shown as below, the current phase is highlight in black bar.

Program Display

The Program Display shows as the following information

: program name, date, nominal value for chamber temperature (set temperature), actual chamber
pressure/temperature, phase duration and indication of remaining time.

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 The process progresses from “Vacuum” phase to “Sterilize”, “Dry”, and “END” respectively.

End of Cycle

The program ends with a message “CAUTION: hot surfaces Danger of Burns”

Press SET button once to go back into the Select Sterilizing/Test Program Display

Unloading the sterilizer

Wait for chamber pressure to increase to 0 PSI, then the chamber door could be opened. To unload the
sterilizer, you should leave the door opened slightly for 5 – 10 minutes, then remove the sterile goods.

Shutting Down the Sterilizer

At the end of the day, switch off the main switch of the sterilizer and also the main breaker. The user
should drain off the steam generator by turning on the drain valve at the side of the sterilizer once a week.

CAUTION!
When unloading the sterilizer the door edges and the chamber are still hot! Do not
touch these surfaces! Danger of burns! When removing the sterilized items we
recommend to wear protective gloves.

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Routine Operation

PREPARING AND PACKAGING OF THE STERILIZATION LOAD

Cleaning the Sterilization Load prior to Sterilization

Thorough cleaning and disinfection is vital when processing and maintaining sterile product supplies.
Cleaning of instruments, flasks, needles, etc., is also necessary to avoid burning residue of fat or albumin,
and causing discoloration in the instruments and the sterilization chamber (brown color tones).

Good instrument cleaning is achieved by keeping them in water for about 30 minutes with a solvent for the
fat and albumin. Instruments should be thoroughly rinsed, with special attention paid to eliminating active
washing agents. The final rinse should be with demineralized water or distilled water, regardless of
whether solid pieces or porous materials are being handled.

Drying the cleaned pieces is a final, indispensable step before they are sterilized. If the manufacturer
recommends treatment with oil prior to sterilization, use only special emulsifying instrument oils on the
items to be sterilized.

Hot-ironed or thermally dried textiles may not be packed nor sterilized before they have been allowed to
cool and to reach room temperature.

According to the requirements of an adequate treatment in terms of the accepted rules for supply with
sterile materials the careful cleaning and disinfection of the sterilization material is indispensable!

Wrapping and Loading Sterilization Material

Use bags made of either sterilization paper acc. to EN868-4 transparent sterilization wrapping material acc.
to EN 868-5 (paper and film) for wrapping and storing single pieces before and after sterilization. The
closure seams should be at least 6 mm wide. Double seams are recommended. At least 30 mm of space
should remain between the seam and the items to be sterilized. As an alternative, sheets of non-woven
material (i.e. non-woven fabrics) may also be used as wrapping material.

Bags and tubes made exclusively of plastic are unsuitable as sterilization wrapping materials and should
always be avoided or at most used only subsequently as storage wrapping materials.

When shallow trays and cartridges or containers are used, we recommend only those which are made of
aluminum. Items to be sterilized dry much less effectively with other materials (plastic, stainless steel), so
that longer drying times are required.

Underlays made of gauze or cellulose are not suitable!

Wrapping of Solid Items for Sterilization

When an instrument set is prepared, ensure that the mesh tray full of instruments does not weigh more
than 8.5 Kg. The shallow trays and the containers must be filled in such a way that the contents do not
protrude beyond the edges of the shallow tray or container. If necessary, the materials should be spread
over two mesh trays, baskets or cassettes. The maximum filling height should be limited so that there is a
minimum gap of 2 cm between the top of the contents and the top edge of the container or the underside
of its lid, or the bottom of the next basket up (when piled up).

When instruments and utensils are wrapped individually or in sets, in paper bags or mixed paper-
transparent film bags according to EN 868-4 and EN 868-5, either in simple or double wrapping, ensure
that they are not placed flat in the sterilization baskets but rather vertically against one of the sides and
supporting each other so that they remain in this position.

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When loading the baskets, also make sure that hollow vessels such as shallow dishes, bowls, cups or
empty bottles are always positioned with their openings downward so that any condensate which forms
can run off and is not collected within the vessels.

Wrapping Porous and Temperature-Sensitive Materials

Cloths, jackets, other textiles and similar types of bandaging materials should be packed into cassettes
vertically standing. The weight of a full sterilization cassette or container should not exceed 7 kg. This also
applies for making packages of laundry which are wrapped in paper or combination materials and placed in
a sterilization basket. When paper is used to package items to be sterilized, the standard requirements of
EN ISO 11140-3 should be adhered to. For wrapping rubber and temperature sensitive materials the same
wrapping as for textiles should be used analogously. Here too, it is suitable to pack the items singly or in
sets in the same way as instruments. If gloves are sterilized, especially in pairs, it is advisable to use paper
bags and place the gloves stretched out inside, making sure that they do not touch each other. When
metal sterilization containers are used, care must be taken that temperature sensitive materials are placed
in them in such a way that there is no direct contact with the metal. Intermediate layers of paper and
textile are permissible. This should be applied for the packing of materials which tend to stick to
themselves.

Wrapping solid Instruments

The wrapping for instruments and heavy instruments can be a single or double layer of transparent
sterilization wrap. Sterilization can also be done in cassettes or containers with no need for wrapping
beforehand.

The standard requirements of EN 868-3 must be taken into account when the items to be sterilized are
wrapped in paper. In case of large quantity loads of wrapped, solid items to be sterilized, the load should
be distributed as evenly as possible over two sterilization baskets or several sterilization cassettes.

Packets for sterilizing must be placed in the baskets in such a way that they do not lie flat but rather in
vertical position against one of the sides, supporting each other so that they remain in this position.
Horizontal surfaces, where condensation can form, should be avoided. Containers or objects with hollow
spaces should be placed so that any condensation that may form inside them can leave and not remain
within the object

OPERATING THE STERILIZER

Switching on and off the sterilizer takes place via the mains switch in the operation unit (NSA). Then, the
initialization of the control system takes place automatically and the main menu is displayed and in
sterilizers with built-in steam generators the preheating of the steam generator starts.

Preheating the Sterilization Chamber

The double-walled jacket of the sterilization chamber is heated automatically. Pressure is regulated
automatically.

Vacuum test

This test is performed without load, and makes it possible to check the tightness of the sterilization
chamber. Thus it shall be ensured that air, which penetrates during the vacuum phase possibly through
unavoidable smallest leaks into the chamber does not exceed a certain quantity. Higher quantities of
residual air inhibit the steam penetration of the goods to be sterilized and thus the success of the
sterilization.

NOTE:
We recommend to perform the vacuum test daily, however at least once a week prior to starting the Bowie
Dick test program (see below) or prior to starting the first sterilization cycle.

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After selecting, the vacuum test program is started. It ends properly with the indication of an acceptable
pressure increase (∆p <13 hPa/10 min). When necessary the program ends with an abortion or a failure
message.

Desecration- and Steam Penetration Test (Bowie Dick Test)

The Bowie Dick Test Program examines the desecration- and steam penetration performance of the
sterilizer. It permits the detection of specific process errors, harmful amounts of residual air or certain
technical defects.

For porous sterilization materials (e. g. textiles) this test is standardly performed at 134°C by using a
standardized test package (EN285, chapter 8), as the only load. With the help of a loading trolley the test
package must be inserted into the chamber center, arranged approximately 100-200mm above the
chamber floor. The test package consists of folded cotton sheets. In the center of the test package a
sheet of paper with a chemo-indicator is inserted. The indicator´s change of color is evaluated after the
test has been performed. For making and preparing the test package and for evaluation of the test results
we refer to the data of the manufacturer of the indicator.

For hollow devices (e. g. hoses, complex instruments) this test is also performed at 134°C by using a
suitable Helix-Test Device (Process Challenge Device, PCD) as the only load. This must be arranged in the
chamber center, e.g. with the help of a loading trolley. The hollow device-PCD consists of a long tight
plastic hose, closed at one end with the test device receptacle. The receptacle contains a suitable chemo-
indicator. The change of color of this indicator serves for evaluation of the test result. For making and
preparing of the PCD and for evaluation of the test results we refer the data of the manufacturer of the
indicator.

NOTE:
We recommend to perform the deaeration- and steam penetration test once a day prior to routine
operation, i.e. before starting the first sterilization program.

Loading the Sterilizer with Sterilization Material

The loading can also take place with sterilization containers in cartridges and in baskets (stacking version).
In order to avoid contact with door and chamber surfaces where condensation forms, the loads of the load
carts may not exceed the mass of the sterilization units. If the loading trolleys are loaded with instrument
cartridges in stacks, the heaviest ones should always be on the bottom in order to prevents strong flows
of condensation.

In case of mixed loads, care must be taken that baskets are above cartridges rather than vice versa. Here
too, lighter containers should be on top of heavier ones and containers with absorbent, porous goods
should be placed above those with solid materials.

CAUTION!
When loading and unloading the sterilizer it is possible that the door leaf and the
chamber are heated. Do not touch these surfaces, danger of burns!

Starting and Running a Program

See, the above chapter “Operating the Sterilizer”

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Process Control and Documentation

During the course of process run, the relevant parameters are constantly monitored, displayed, and
updated in accordance with the selected display menu.

The control system monitors these parameters internally and compares them with the nominal values
assigned to each program phase. If there are deviations which exceed the values specified for these
phases, a message or an alarm signal is given depending on the steps which must be taken as a
consequence.

All relevant process parameters, messages and alarms are printed out on the built-in alphanumeric printer.
This permits a correct standardized documentation of the process. A sample printout and explanations of
the individual lines is given below.

The built-in alphanumeric printer uses thermal-paper. To ensure the legibility and document storage
required in EN 285 the thermal paper must be used.

A correct storage of thermal paper is important for stability of images and printability. Store at normal
humidity and temperature conditions of of 50% r. h. Do not store paper in plastic bags or plastic
wrappings. Avoid direct solar radiation and radiant heat. Do not use adhesive tape on the paper.

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30 of 39 M-A8P Rev.01
According to standard, the sterilizer is equipped with a digital printer for automatic documentation of the
most important operating- and process data as well as necessary messages and alarms.

A sample of a protocol printout and explanations regarding the individual blocks of information is shown in
figure above.

Process Control with Chemo Indicators

a) Indicator Tape it is used to seal the packages. Indicator tape is a process indicator, i. e. it shows
only if the package has been exposed to a sterilization process or not. The indicator tape must
correspond to the requirements of EN ISO 11140-1 .

b) Indicator Stripes They are inserted into the center of the load (e. g. textile package) and indicate
whether the required temperatures have been reached and whether the suitable penetration of
steam has taken place during a suitable duration of time.

c) Hollow Device Test Systems acc to EN 867-5 with chemo indicators of class 1 according to EN
ISO 11140-1 can be added to each batch and indicate if the process had a sufficient deaeration
and steam penetration at specified process conditions .

Process Control with Microbiological Indicators

Control of the sterilization process with bio-indicators is used in special cases within the scope of type tests
and periodic validation. Within the scope of routine operation this method is generally not workable
because evaluation and correct interpretation of the results require a respective special experience.
Furthermore the results of the test are only available some days after execution of the test (see also
annex).

Unloading the Sterilizer

If a program has ended successfully you can open the door on the unloading side in order to remove the
sterilization material and/or the loading trolley(s).

CAUTION!
When unloading the sterilizer the door edges and the chamber are still hot! Do not touch these
surfaces! Danger of burns! When removing the sterilized items we recommend to wear
protective gloves.

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Post Treatment of the sterilized Material

Every items sterilized with steam contains residual moisture upon removal from the sterilizer; this should
be allowed to evaporate while the material is cooling off.

Porous sterilized items can be considered adequately dry if their gain in weight due to residual moisture at
the time they are removed from the sterilizer is less than 1.0%. The upper limit for instruments is 0.2%.

This factor is particularly poor in the case of stainless steel or chrome-plated brass containers, as
compared to those made of aluminum or baskets. When cartridges with perforated bottoms are used, care
must be taken to position them so that these perforations are not blocked while they are cooling down to
room temperature.

Grates are particularly suitable for this since modern cartridges and containers have an indented edge for
better closure.

Cartridges should also be stacked on one another during the cooling and evaporation period.

Subsequent Operation

The sterilizer remains switched on and the doors remain closed. As many sterilizations as desired can be
carried out in succession or with pauses between.

Switching off the Sterilizer

At the end of the day, switch off the main switch of the sterilizer and also the main breaker. The user
should drain off the steam generator by turning on the drain valve at the side of the sterilizer.

IMPORTANT:
The unit, the water and if necessary the steam supply should be turned off after completion of the last
sterilization of the day.

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Alarm and Error Messages
The functions and operating conditions of the sterilizer are continuously monitored by the control system.
In case of deviations and operating errors, alarm and warning messages appear on the display and are
printed out by the processing data printer if necessary.

ALARMS

Alarm Messages
The following alarm messages can be triggered:

Code Messages Cause Location & Correction

I4 INPUT 04 WATER Steam generator water loading 1. Check for pressure of
SUPPLY DAMAGED time over limit of 5 min. water supply of steam
generator
2. Check for water pump
function
3. Check for function of
magnetic contactor
controlling water pump

I6 INPUT 06 MAGNETIC Vacuum pump overload 1. Check for vacuum pump

CONTACTOR function
DAMAGED 2. Check for function of
magnetic contactor
controlling vacuum pump
3. Check for electrical supply
of vacuum pump

- LOW Sterilizing temperature drop 1. Verify door gasket and

TEMPERATURE replace if needed
2. Check for the function of
steam trap
3. Check for the pressure
vessel leaks

- TEMPERATURE Temperature sensor damage 1. Check the function of

SENSOR DAMAGE temperature sensor and
change if needed
- DOOR SENSOR 1. Door sensor switch 1. Reset the sterilizer by
SWITCH DAMAGE damage pressing RST button on
2. sterilizer door not closed the control unit
properly 2. Check for the function of
door sensor switch
3. Verify sterilizer door
closing

ATTENTION!
If failures are indicated and their cause can not be eliminated, inform the respective customer service!

NOTE, IMPORTANT:
If problems which occur during the course of processing lead to a process abortion, a recovery steps is
automatically started; it sets the unit back into a pre-defined, safe operational status so that the door
can be opened. The sterilization material has to be regarded as NOT STERILE!

INTERFERENCES WITH OPERATIONAL READINESS

If the sterilizer is not ready for operation upon pressing the start-key (or prior), following points have to
be regarded.

▪ Is there an alarm- or error message?

For further information see chapters regarding Alarm or Error messages.

33 of 39 M-A8P Rev.01
 ▪ Is (are) the chamber door(s) properly closed?
The chamber doors must be driven in front of the chamber as far as they will go (firm door
stop). Otherwise the electric door contact switch will not react.

▪ Has a safety fuse been triggered?

Check the fuses in the electro cabinet and on the on-site main fuse of the sterilization device.
(Examination by technically trained personnel).

▪ Is steam available?
See pressure indication manometer „Steam“, minimum pressure 2,2 bar.
(Examination by technically trained personnel).

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

minimum water pressure 2,5 bar
(Examination by technically trained personnel).

In case of problems with the equipment please inform the authorized personnel. If the cause of the
problems cannot be detected or eliminated inform the Technical Customer Service.

CAUTION!
The steam sterilizer may not be operated if problems occur which endanger persons operating it or
others or the success of the sterilization process.

MANUAL CONTROL OF THE PROCESS

All processes that are performed by the sterilizer consist of several successive process steps. If necessary,
it is possible to jump directly to the next processing phase even if the conditions for doing so have not yet
been met during normal operation. However, this possibility is intended only for maintenance purposes,
for the authorized technical service personnel, or for the Customer Service Department.

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Care, Maintenance and Inspection Schedules
Preventive maintenance has the purpose of ensuring that parts or modules which are subject to wear
and tear are exchanged before they can have an adverse effect on the process. These actions also help
to maintain the system in a flawless state of operational readiness.

After having carried out repairs respectively affected functions of the sterilizer need to be tested.

Regular care and maintenance checks are mandatory for this and should be carried out by the person
operating or using the unit or by a trained machine attendant.

Inspection and maintenance may only be carried out by technically trained specific personnel. We
recommend a semiannual inspection and maintenance by our Customer Service Department and the
conclusion of a corresponding service contract.

The first measure to preserve impeccable operational readiness of the sterilizer is to ensure that the
device
- is properly installed
- is only operated with media according to specifications
- is operated according to the specifications of this operating instruction.
This includes the performance of the examinations, care- and maintenance works that are described in
the following table.

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Preventive Maintenance Time Table
Interval Inspection location/ Description Inspection/ Action Who?

Daily, chamber walls, visual control for Operator

before door seals, cleanness, operational
operation operating media readiness

desecration, performing the Bowie Dick test

steam penetration

Weekly, system tightness performing the vacuum test

before
operation

Weekly chamber floor cleaning, inspection

lint sieve in the drain spout desalination
steam generator

printer, testing of operational Company

water level indicator steam readiness, Authorized
generator function test Technician
safety contact bar,

Every 3 safety valve for chamber, lift off

months preheating jacket and steam
generator

filters and sieves in the piping cleaning, examination

system

Semiannual complete sterilizer inspection,

and if maintenance, safety
necessary technical inspections

Annually ventilation filters, change, clean, inspect

sieves, valves

complete sterilizer function test

calibration
If
necessary complete sterilizer effectiveness test,
performance evaluation
(validation)

chamber door change seal

Every 5 complete sterilizer major overhaul Company

years Authorized
Technician

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Care and Maintenance by the Operator
Some actions of the afore mentioned time schedule have to be performed by the operator or the person
which is responsible for the sterilizer.

Daily
Following actions have to be performed daily:
●Visual inspection of the chamber walls, chamber floors, sieve in the drain spout and
the door seal for cleanness. If necessary remove contaminations with a damp cloth.
Cleansing agents must be free of halogens and may not contain elements which
accumulate residuals.

ATTENTION!
Use demineralized or distilled water to rinse the chamber after cleaning. Afterwards re-insert the lint
sieve.

● Check whether there is enough paper on the paper roll for the built-in printer.
The last ca. 100 cm of the paper are marked by a red strip which is running from the right to the
left side of the paper. If necessary, insert a new paper roll.

● We recommend to perform vacuum test and Bowie Dick Test daily however, at least weekly in order
to ensure and document the process technical functionality of the device beyond the a.m. points.

Weekly
Additionally to the time table, following works should be performed once a week:
●Clean the external surfaces with a damp cloth and neutral cleaning agent and disinfection
agent.

● Clean the inner walls of the (not heated) sterilization chamber with a damp cloth
using (a little) neutral (not acerbic) soapy water.

ATTENTION!
●Make sure that water does not get in contact with the electrical parts of the equipment in order to
ensure the safe operation of the sterilizer and to prevent endangerments of service personnel.

● Do not use pressurized water in order to clean the sterilizer.

● Do not use abrasive detergents to clean the surfaces.

● Do not use chemical aggressive (alkaline or acidic) detergents.

Please contact the Customer Service if there are contaminations or coatings on the surfaces
which can not be removed in this way.

● Make sure that there are no residues in the lint sieve. If necessary, clean it retrally under running
water.

● Clean the outer surfaces of the door seal with a damp cloth and neutral cleaning
agent when the door is open. For this it is not necessary to remove the seal from
it´s groove.

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ATTENTION!
If the quality of the raw water is particularly strained and the quality control for the
feeding water is not sufficiently ensured, we recommend to completely exchange the
vessel water weekly as prophylaxis.

● If the sterilizer is operated with external steam (see annex, chapter 2.1.17) the integrated
steam generator is switched off. To maintain the operational readiness of the integrated steam
generator water level and water quality have to be monitored. Furthermore, we recommend to
switch on the integrated steam generator once a week and to run an empty batch (e. g. using
the Bowie Dick-Test Program).

Cleaning and Changing the Door Seal

NOTE:
You can only open the door on the unloading side (SD) after a sterilization process
has successfully ended. In order to change the door seal, please establish this condition priority.

CAUTION!
Clean or change the door seals only if the sterilizer is completely cooled down, in order to avoid burns.
Please proceed as follows:

● Insert a screwdriver between seal and the groove, and use leverage to remove the seal cautiously and
take care not to damage it. If necessary, repeat this process until you can grasp the seal with your fingers
and then pull it out entirely. Please take care in doing so that you do not damage the sealing groove with
the screwdriver.
● If you merely wish to clean the seal, this is best done with a neutral soap solution and, if necessary,
methyl alcohol.

ATTENTION!
Do not use aggressive solutions or detergents and do not use silicone oil which contains benzoyl!

● Place the cleaned or new seal evenly into the groove. It is best to begin at the top in the middle. Then
follow along the four corners so that the length of line is uniformly distributed over the four sides. Now you
can press the seal completely into the groove. If necessary, use the back of a screwdriver handle.
● Re-attach the activating plate to the safety contact bar and fix it with the two screws.
● Open and close the door several times, to ensure proper function.
● Then perform a vacuum test to verify the tightness of the system.

Shutdown of the Sterilizer

(shutdown for longer periods of time)

If the sterilizer is to be taken out of operation for a longer time, we recommend that you have this be
carried out by the Customer Service Department.
• Water must be removed from all tanks, pipe components and lines. The pressure pump for the
vacuum system must be filled with a preventative against corrosion.
• Remove the connection hoses and the rest of the water.
• Wipe the sterilization chamber dry.

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 • If necessary, clean and dry the guide rail framework, the load carts and the baskets and store
them in the sterilization chamber. Close and lock the doors.
If necessary, have a professionally trained person disconnect the mains connection (remember to
•
turn off the mains connection current beforehand.

Disposal Information
• Dispose your old devices according to the legal regulations.
• Dispose of old batteries and accumulator batteries via specialized trade or a resource container for
old batteries.
Do not dispose of batteries via residual waste!
• Dispose of electric and electronical components as discarded electronics.
• Dispose of housings made of recyclable plastic via a collecting bin for plastic.
• Dispose of device parts made of metal via scrap metal utilization.
•

39 of 39 M-A8P Rev.01
Diagram