Webeco A 35-S User manual

Operating Instruction

Steam Sterilizer

A 35 - S

O:\EUK\TEDOK\GA AKTUELL\A35\ENGLISCH\A35SE1-2.DOC 04/98

Table of Contents

Page

1. Preliminary Notes............................................................1

1.1 General Remarks........................................................1

1.2 Safety Indications.......................................................3

2. Apparatus Description.....................................................5

3. Area of Application...........................................................5

4. Specifications..................................................................6

4.1 Installation and Connection Data.................................6

4.2 Ambient Conditions .....................................................6

4.3 Technical Parameters.................................................7

4.4 Standards and CE-Conformity .....................................8

5. Apparatus Overview......................................................10

6. System Functions..........................................................18

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Page

7. Installation and Operation..............................................22

7.1 Installation................................................................22

7.1.1 Water Supply ......................................................23

7.1.2 Electric Supplies..................................................24

7.2 Operation..................................................................25

7.2.1 Operating Prerequisites.......................................25

7.2.2 Operating Procedure...........................................25

7.2.2.1 Loading the Sterilizer.....................................25

7.2.2.2 Cleaning of the Sterilization Material prior to

Sterilization................................................................27

7.2.2.3 Wrapping and Loading of Sterilization Load...28

7.2.2.4 Post-Treatment of Sterilization Material.........31

7.3 Programs ..................................................................32

7.3.1 Program Selection/Start......................................32

7.3.2 General Program for Instruments 134°C..............33

7.3.3 General Program for thermolabile Instruments 121°C....35

7.4 Notification- and Failure Reports ...............................36

7.4.1 Indications ...........................................................36

7.5 Automatic Safety Lock..............................................39

7.5.1 Door Spindle Interlock.........................................39

7.5.2 Unlocking of Door Spindle ....................................39

7.5.3 Opening the Door during Power Failure...............40

7.6 Shutdown of Apparatus .............................................40

7.6.1 Temporary Standstill ............................................40

7.6.2 Shutdown of apparatus for standstill or transport.40

7.7 Activating/Deactivating Additional Cooling .................41

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Page

8. Effectiveness Test.........................................................42

8.1 General.....................................................................42

8.2 Biological Test..........................................................43

9. Maintenance Work........................................................45

9.1 General.....................................................................45

9.2 Maintenance.............................................................46

9.3 Cleaning....................................................................47

9.4 Repairs.....................................................................47

10. Spare Parts, Accessories ............................................49

11. Operation Quick Guide ................................................51

12. Index...........................................................................54

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1. Preliminary Notes

1.1 General Remarks

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

• It is appliance orientated and contains the apparatus
description, handles the assembly, starting procedure,
cleaning instructions, maintenance, and maintenance
roster, including effectiveness test and repairs, as well as
storage and transport requirements.

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

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

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

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

The references to illustration and position numbers in the

text are placed in brackets, i.e. (3/5) refers to illustration
number 3, position number 5.

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1.2 Safety Indications

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

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

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

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

• Please read carefully these operation instructions before
starting installation or preparing operation.

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

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

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

- these Operating Instructions

- all other applicable supplemental user instructions

- applicable national laws and safety regulations

• Preservation of the maintenance schedule shall be
ensured by the user. Maintenance and service actions
shall be performed only by the manufacturer or by its
authorized representatives. If maintenance actions will be
performed by personnel of the user, he is responsible for
the safety and maintenance indications to be followed.

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2. Apparatus Description

Item Description Part-No.:
A35-S 029949

Manufacturer:
Webeco Hygiene in Medizin
und Labor GmbH & Co. KG,
Mühlenstraße 38, 23611 Bad Schwartau

3. Area of Application

This Small-Steam-Sterilizer provides sterilization of wrapped
or unwrapped surgical and dental instruments at 134°C as
well as sterilization of thermolabile sensitive to heat
materials at 121°C. It is designed for use at on-site
locations.

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4. Specifications

4.1 Installation and Connection Data

Dimensions (heightxwidthxdepth) : 440x500x700mm
Installation Base (widthxdepth) : 500x550mm
Chamber Dimensions (diam.xdepth): 250x380mm
Weight : ca. 45kg
Electrical Requirements : 230V/50Hz/10A
IEC 536 Protection Class : I
Supply Connector for Cooling Water: G ¾

4.2 Ambient Conditions

Operation Storage and

Transportation
Temperature : 15-35°C 5-50°C
Pressure : 850-1100mbar 650-1150mbar
rel. Humidity : 0-85% rel. humidity 0-65% rel. humidity

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4.3 Technical Parameters

Production-No. :
Year of Delivery :
Sterilizer Pressure Chamber
Permissible

operation overpressure : 3 bar
Test pressure : 3,9 bar
Working Pressure : 1,1 / 2,2 bar
Permissible

operating Temperature : 138 °C
Working Temperature : 121 / 134 °C
Capacity of

Sterilization Chamber : 19,5 Liter
Heating System : electrical
Heating Capacity : 2,0 kW
Acoustic Power Level : <85 dB(A)

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4.4 Standards and CE-Conformity

0197

According to the EEC Medical Device Directive (MDD)
93/42/EEC the small steam sterilizer WEBECO A 35 - S is a
medical device and with reference to Annex IX of the MDD to
be classified as class IIa medical device.

WEBECO GmbH & Co. KG has established a quality
management system according to DIN EN ISO 9001 and DIN
EN 46001 which has been approved by a "Notified Body"
applying Annex II, article 3 of the MDD (reg. no. SY 9711455

01).
On this base the small steam sterilizer WEBECO A 35 - S has

been applied to a regular procedure for evaluation of
conformity and has been proved to be compliant with the
essential requirements of Annex I of the MDD. This allows the
sterilizer to be marked by the sign

A respective formal Declaration of Conformity has been duly
signed.

Conformity of the sterilizer type A 35 - S in accordance with
this instruction manual with the a.m. MDD 93/42/EEC also
includes compliance with the essential requirements of the
EEC-regulations as listed below:

• 73/23/EEC (Low Voltage Directive)
in conjunction with 93/68/EEC

• 89/336/EEC (EMC-Directive)
in conjunction with 92/31/EEC and

93/68/EEC

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As far as applicable for a.m. directives the apparatus A 35 - S
complies with the following standards:

• EN 61010-1 • EN 55011 • EN 50082-2

• EN 61010-2-041 • EN 50081-1

• applicable standards of the series DIN VDE 0100, in

compliance with IEC 364

Furthermore this sterilizer complies with DIN 58 946, part 5,
actually known requirements of the future European standards
for small steam sterilizers, requirement level S (draft prEN
13060-1 and draft prEN 13060-4).

The apparatus contains a pressure chamber of "Test Group I"
in compliance with §8 of the German Regulations for Pressure
Vessels. We thus confirm, that pressure vessel and locking
device are constructed in accordance with all applicable
Technical Regulations for Pressure Vessels and AD­regulations, have been properly manufactured and submitted
to a fluid pressure test. In addition, an acceptance test
comprising a specification test and an equipment test has
been administered by the quality assurance section.

Within the framework of a type test in accordance to the
German Regulations for Pressure Vessels the register mark
TÜV- DB 123/01 was formally issued.

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5. Apparatus Overview

167

54328

Illustration 1: WEBECO A 35 - S, Front View

1. Pressure gauge 5. Drainage Valve

2. Main Switch 6. Chamber Door

3. Operation Quick Guide 7. Apparatus Name Plate

4. Aeration Filter 8. Cover Feed Water Reservoir

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5.1 Pressure Gauge (1/1)

With the black pointer of the pressure gauge the
relevant/present chamber pressure is displayed.
The red drag pointer shows the highest pressure that has
been reached during the program-run, if he has been reset to
„0“ before the program-start.

green: appropriate conditions
red : inappropriate conditions
>0< : door may be opened

5.2 Main Switch (1/2)

The main switch lightens green when it is switched on.

5.3. Aeration Filter (1/4)

Please pay attention to chapter 9.4 „Replace Aeration Filter“
when changing the filter.

5.4 Drainage Valve (1/5)

To drain the water reservoir put the draining hose onto the
valve and open it by turning it left.

5.5 Chamber Door with Rotary Closing Device (1/6)

Please pay attention to chapter 9.4 „Replace Door Sealing“
and „Grease Spindle at the Rotary Closing Device“.

5.6 Apparatus Name Plate (1/7)

If there are any questions to the customer service please
provide the production-No. which is indicated here.

5.7 Feed Water Reservoir (1/8)

When charging the feed water reservoir for the first time,
15L of demineralized or destilled water have to be filled in. If

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the red display „Water Shortage“ is enlighted, please refill 5L
demineralized or destilled water.

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Illustration 2:

245

678

1

WEBECO A 35 - S, Display- and Operation Unit

3

1. Program Start 121 °C 5. Display Residual Time

2. Program Start 134°C 6. Thermometer

3. Program Indicator 121°C 7. Display Water Shortage

4. Program Indicator 134°C 8. Display Door unlocked

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