Operating Instruction
Steam Sterilizer
A 35 - S
O:\EUK\TEDOK\GA AKTUELL\A35\ENGLISCH\A35SE1-2.DOC |
04/98 |
Table of Contents |
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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 |
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4.1 |
Installation and Connection Data................................. |
6 |
4.2 Ambient Conditions ..................................................... |
6 |
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4.3 |
Technical Parameters ................................................. |
7 |
4.4 Standards and CE-Conformity..................................... |
8 |
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5. Apparatus Overview ...................................................... |
10 |
6. System Functions .......................................................... |
18 |
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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 |
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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 Notificationand 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 |
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7.7 Activating/Deactivating Additional Cooling................. |
41 |
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8. Effectiveness Test......................................................... |
42 |
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8.1 |
General..................................................................... |
42 |
8.2 |
Biological Test .......................................................... |
43 |
9. Maintenance Work ........................................................ |
45 |
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9.1 |
General..................................................................... |
45 |
9.2 |
Maintenance ............................................................. |
46 |
9.3 Cleaning.................................................................... |
47 |
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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 workor 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 workor 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 |
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Weight |
: |
ca. 45kg |
Electrical Requirements |
: |
230V/50Hz/10A |
IEC 536 Protection Class |
: |
I |
Supply Connector for Cooling Water: |
G ¾ |
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4.2 Ambient Conditions
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Operation |
Storage and |
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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. |
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Year of Delivery |
: |
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Sterilizer Pressure Chamber |
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Permissible |
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operation overpressure |
: |
3 bar |
Test pressure |
: |
3,9 bar |
Working Pressure |
: |
1,1 / 2,2 bar |
Permissible |
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operating Temperature |
: |
138 °C |
Working Temperature |
: |
121 / 134 °C |
Capacity of |
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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
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
0197
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 |
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∙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 TÜVDB 123/01 was formally issued.
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5. Apparatus Overview
Illustration 1: WEBECO A 35 - S, Front View
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1 |
2 |
3 |
4 |
5 |
6 |
7 |
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.
5.5Chamber 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“.
5.6Apparatus 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:
WEBECO A 35 - S, Displayand Operation Unit
8
7
6
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3 |
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1 |
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2 |
4 |
5 |
1. |
Program Start 121 °C |
5. |
Display Residual Time |
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2. |
Program Start 134°C |
6. |
Thermometer |
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3. |
Program Indicator 121°C |
7. |
Display Water Shortage |
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4. |
Program Indicator 134°C |
8. |
Display Door unlocked |
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