- Frank`s Hospital Workshop
Contents
1. 1 Cool water supply condensate drainage connector G 2 Cool water intake connector G 3 Electrical connecting cable with sealed contact plug 4 Manufacturer Name Plate 16 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 5 16 Cooling Water Condensate Drainage 3 1 Connect hose for shared outlet of condensate and if necessary cooling water here ATTENTION Do not use the optional salable condensate reservoir when using the A35 S with supplemental cooling Operating the apparatus with supplemental cooling requires the connection of the connection pipe contained in supply schedule to an outlet to be provided on site see chapter 7 1 5 17 Cold Water Supply 3 2 When using supplemental cooling see chapter 7 7 connect pipe here as described in chapter 7 1 1 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 17 Vers 02 04 98 6 System Functions The WEBECO Small Steam Sterilizer A 35 S operates with streaming and saturated steam and functions according to the flow processing procedure The feed water which is required for the production of steam is filled in a feed water container This feed water container has to be filled with demineralized or deionized water approx 15 liters after removing the cover of the housing From this container the required amount of feed water will be metered into the sterilization chamber automatically during the program run2. IMPORTANT Operation with supplemental cooling without water supply leads to highly reduced drying capacity A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 41 Vers 02 04 98 8 Effectiveness Test 8 1 General The effectiveness of the sterilization process of Automat A35 S to be tested with thermoelectric measurements and or biological indicators according to DIN EN 866 3 The test is based on DIN 58 946 part 8 Steam Sterilizers Small Sterilizers Effectiveness Test According to this standard the following tests are to be conducted operation procedure test prior to first use Le when acquiring the apparatus periodical tests in six months intervals special test to detect necessary repairs or replacement of spare parts which might influence sterilization performance special test when unsatisfactory sterilization performance is suspected IMPORTANT The tests and their results are to be documented 42 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 8 2 Biological Test The two sterilization programs of the A35 S are to be tested The test is to be conducted with biological indicators according to DIN EN 866 3 part no 00 92 92 For this test sterilization material and sterilization wrapping appropriate for respective purpose of the sterilization program is to be used The biological test of the A 35 S is to be conducted in accordance with DIN 58
3. green appropriate conditions red inappropriate conditions gt 0 lt 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 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 11 Vers 02 04 98 the red display Water Shortage is enlighted please refill 5L demineralized or destilled water 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 Illustration 2 WEBECO A 35 S Display and Operation Unit 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 A35SE1 2 WEBECO Hygiene in Medizin und Labor
4. 04 98 7 1 1 Water Supply With regard to the water supply the provisions of the DVGW in accordance with DIN 1988 part 4 Technical Regulations for Drink Water Installations are to be followed a Cooling Water Inflow 3 2 The cooling water delivery pipe hose with a connector on both sides G3 4 is connected to the cooling water inflow 3 2 and the on site G water valve The cooling water inflow is provided with a hinged cover which is to be removed from the cooling water delivery pipe before it is connected The hinged cover should be stored at a secure place In the case of equipment failure the back flow of processed water used drinking water into the drink water system is to be prevented by a back flow prevention device either as single safety system at the apparatus supply or via a collective safety device system for the work area department practice etc As single safety system a back flow prevention device with pipe ventilation which screws directly onto the water valve G 3 4 may be supplied article no 5 1630 0120 to be installed at the wall Please note that the water valve must be situated at least 150 mm above the apparatus supply see chapter 10 IMPORTANT When deinstalling the Water Cooling the cooling water inflow has to be tightened with the lock again Otherwise water leakage is possible A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 23 Vers 02 04 98 b Coolin
5. 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 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 3 Vers 02 04 98 e 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 e 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 A WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 2 Apparatus Description Item Description Part No A35 S 029949 Manufacturer Webeco Hygiene in Medizin und Labor GmbH amp Co KG MuhlenstraBe 38 23611 Bad Schwartau 3 Area of Application This Small Steam Sterilizer provides sterilization of wrapped or unwrapp
6. the conditions for stainless steel and chromium plated brass are particularly unfavourable Overloading the sterilizer has negative consequences for the drying result Passing the commended times of sterilization without additional cooling the drying of the sterilization goods is significantly reduced so that additional drying times e g 5 10 minutes evaporation with slightly opened door are recommended see chapter 6 INDICATION If dishes or trays are used they should not be set onto flat and solid surfaces The condensate coat created by cooling down to room temperature may subsequently cause soaking of the wrapped sterilization material Therefore dishes and trays are better set on grids or other structured surfaces CAUTION When loading or unloading the chamber the door plate and the chamber walls are preheated Do not touch these areas Danger of burning A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 31 Vers 02 04 98 7 3 Programs 7 3 1 Program Selection Start According to the nature of the sterilization load the following programs may be selected Program 1 General Program for Instruments 134 C Program 2 General Program for thermolabile Instruments 121 C The programs will be started with the respective program start key During operation the running program is indicated by the respective green display 2 3 2 4 At the same time the door spindle will be locked automatically that means t
7. Co KG A35SE1 2 Vers 02 04 98 9 Maintenance Work 9 1 General To ensure continued and proper use of the apparatus regular cleaning and maintenance work is required This is to be conducted by the operator user or person in charge of the equipment Repairs on the apparatus are to be conducted by the manufacturer WEBECO GmbH amp Co KG or authorized customer service only In addition we refer to the operator requirements in accordance with DIN 58 946 part 5 attachment A 4 repeat tests and A 5 special tests ATTENTION The apparatus is not explosion protected therefore the apparatus may not be treated with cleaning or desinfection agency which with air could generate an explosive mixture A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 45 Vers 02 04 98 9 2 Maintenance Times to be Reference performed Test Location Nam e Chamber floor insert tray instrument dishes Wire sieve inside Test or Activity cleaning by user person in charge of equipment according to chapter weekly and if 9 3 required Spindle at rotary closing device greasing by user person in charge of equip according to chapter 9 4 ment cleaning by user person in charge of equipment replacing by user or customer service Reservoir according if required to chapter every three 9 4 months Ventilation filter according every 6 to chapter months and if 9 5 required safety te
8. load has to be distributed equal on different sterilization trays if there is a great volume of massive wrapped sterilization goods ATTENTION Plastic bags or tubes are not suitable for sterilization wrapping and should be avoided at all cost i e only used as storage wrapping at a later stage 28 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 The sterilizer A 35 S is supplied complete with an insert tray with removable bearing rails for holding dishes and trays When loading a basket the tray is removed A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 29 Vers 02 04 98 IMPORTANT For an optimal drying transparent sterilization wrapping is recommended paper and foil according to DIN 58 953 in relation with dishes made of aluminium When using other wrappings res other materials plastics stainless steel the drying of the sterilization goods is significantly reduced so that additional drying times e g 5 10 minutes evaporation with slightly opened door are recommended ATTENTION Cellulose and cotton surfaces are not suitable 30 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 2 2 4 Post Treatment of Sterilization Material When unloaded from the sterilizer all material sterilized with steam contains residual moisture which should evaporate freely when the material is cooled Compared to containers made from aluminium or wire baskets
9. of the door ATTENTION Be careful not to damage the inside of the door and of the seal groove e Insert new door seal into groove and apply slight pressure to the door with the closing spindle e _ Switch off the unit again ATTENTION e Lubricants may not be used 48 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 10 Spare Parts Accessories The following spare parts and accessories are available from the manufacturer or an authorized customer service Article Aeration Filter Drainage hose reservoir Delivery hose G3 4 Supply hose G3 4 G3 4 Insert Tray 2 or 4 Parts Removal lever for Traydish Removal lever standard Door Seal Instrument Dish aluminium 35x18x3cm Sterilization Container aluminium 35x18x5cm Sterilization Container aluminium 35x18x18cm Sterilization Basket stainless steel 35x18x8cm Sterilization Basket stainless steel 35x18x18cm Tray dish aluminium 28x19x4cm Tray dish aluminium 28 x 19 x 3 cm Back Flow Prevention Water Stop Device A35SE1 2 Vers 02 04 98 No old 5 2014 0604 2 0120 0106 5 6110 0006 5 6110 0007 1 0901 3518 11112 4920 1 1112 4750 5 5405 3502 10901 3518 11109 6481 1 0935 1818 1 5904 3501 1 5904 3502 15928 1904 15901 2819 5 1630 0120 5 4107 0200 No new 02 31 79 01 21 69 02 51 49 02 51 50 00 16 85 00 15 93 00 15 89 024847 00 11 63 00 14 69 00 11 93 00 92 32 00 92 33 00 92 74 00 92 2
10. of the wrapping The wrappings may not be placed on top of each other res they may not overlap Items with areas on which condensate may be produced are to be arranged so that accumulating condensate may drain out After loading the door is to be shut Give the closing spindle a firm turn clockwise Closing of the door is monitored by a door contact switch ATTENTION The sterilization of liquids i e warmth volatile materials is not permitted Danger of explosion 26 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 2 2 2 Cleaning of the Sterilization Material prior to Sterilization In order to comply with the requirements of sterilization load maintenance proper cleaning of sterilization materials is absolutely essential The cleaning of instruments glassware pipettes etc is also essential to avoid that oil and protein containing contaminants burn in and thereby discolour instruments and sterilizer Scalding Proper cleaning is possible if the instruments are soaked in water which contains fat and protein dissolving substances for ca 30 minutes This is then followed by thorough rinsing and drying of the instruments In addition to the removal of contaminants special care is to be taken that wash active substances WAS are removed For the last rinsing act demineralized water or destilled water shall be used The sterilization material then is to be dried If oil treatment is recomme
11. 5 02 29 39 02 41 73 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 49 Condensate Reservoir 03 01 53 Biological Indicator one item 16002 1310 009292 50 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 11 Operation Quick Guide 1 The water container has to be filled with demineralized or destilled water Switch on mains 2 Load sterilizer see chapter 7 2 2 1 Please see chapter 7 3 for loading instructions 3 Close door and firmly turn closing spindle clockwise 4 Turn the red drag pointer of the pressure gauge 1 1 left until 0 is displayed 5 Start suitable program according to kind of load to be sterilized by pressing the program start key 2 1 2 2 The running sterilization cycle is shown through the program display 2 3 2 4 above the Start key 6 After the start of the sterilization cycle the residual time display 2 5 shows the remaining time until the Program End 7 The end of the program is indicated by a blinking program display 2 3 2 4 The sterilization material may be unloaded While pressure reading gt 0 lt black pointer it has to be tested if the necessary sterilization pressure 1 1 bars 121 C 2 1 bars 184 C has been reached Otherwise the sterilization load must always be considered non sterile 8 Turn the closing spindle counter clockwise for opening of the door see chapter 7 5 A35SE1 2 WEBECO Hygiene in Medizin und Lab
12. 946 part 8 For the biological test 1 to 5 bio indicators are needed for each container or dish dependent of the groth of the sterilization container respectively of the groth of the dish with perforated bottom Additional to this one bio indicator is needed This additional bio indicator is the positive control This indicator is not subjected to the tested method The indicator is not put into the sterilizer it is not treated volume of basket floor space of the quantity of bio container in liter sterilization dish in indicators cm2 ee a DE Sn a a e a VE FREE The bio indicators are placed in the load of the small steam sterilizer at the critical place for the process see picture A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 43 Vers 02 04 98 Arrangement of one bio indicator in the sterilization good Distribution of 3 bio indicators Distribution of 5 bio in the sterilization good indicators in the sterilization The indicators remain in their primary packing paper The indicators have to remain in their packing even after the sterilization process to prevent a recontamination They have to be send in their packing to the WEBECO customer service or an independent hygienic institute There the used bio indicators are fertilized and tested if micro organism grow The untreated bio indicator is fertilized as well and has to show groth 44 WEBECO Hygiene in Medizin und Labor GmbH und
13. GmbH und Co KG 13 Vers 02 04 98 5 8 Program Start Key 121 C 2 1 This key starts the program Instruments Thermolabile 121 C 5 9 Program Start Key 134 C 2 2 This key starts the program Instruments General 134 C 5 10 Program Indicator 121 C 2 3 During the program run the green display is enlighted The end of the program is signalized by a flashing indication 5 11 Program Indicator 134 C 2 4 During the program run the green display is enlighted The end of the program is signalized by a flashing indication 5 12 Display Residual Time 2 5 The residual time is shown in minutes from the program start to the program end 5 13 Thermometer 2 6 The Thermometer shows the actual temperature in the chamber grey appropriate conditions red inappropriate conditions 5 14 Display Water Shortage Feed Water Reservoir 2 7 Fill demineralized water or destilled water into the reservoir when the indication is red The device can not be started in this situation 5 15 Display Door unlocked 2 8 The indication is shining yellow when the door lock is unlocked Please open the door only in this situation 14 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 additional to this the indication chamber pressure has to show gt 0 lt A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 15 Vers 02 04 98 Illustration 3 WEBECO A 35 S Rear View
14. Interlock Rennen 39 7 5 2 Unlocking of Door Gpmdle RR 39 7 5 3 Opening the Door during Power Failure 40 7 6 Shutdown of Apparatus sss eee eee ee 40 7 6 1 Temporary Giandenl RR RR 40 7 6 2 Shutdown of apparatus for standstill or transport 40 7 7 Activating Deactivating Additional Cooling 41 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 8 Effectiveness Tester samt 42 8 1 0 nennen nennen nennen 42 Ee e ie Her ek EE 43 9 Maintenance Work 45 9 1 TEE 45 9 2 MaintenaN e ee Net 46 RR Tele EE 47 GE e EE 47 10 Spare Parts ACcessortes eee 49 11 Operation Quick Guide se sese 51 12 Tote E EE 54 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG lll Vers 02 04 98 1 Preliminary Notes 1 1 General Remarks e 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
15. Operating Instruction Steam Sterilizer A35 S O EUK TEDOK GA AKTUELL A35 ENGLISCH A35SE1 2 DOC 04 98 Table of Contents Page 1 Preliminary Note S aaa a a a 1 Tal General Remake 1 1 2 Safety Indications nen nenn nennnnn nennen 3 2 Apparatus Description nenne nennen ernennen 5 3 Area Of Appltcatton nennen nennen nennen 5 ee 6 4 1 Installation and Connection Data nn 6 4 2 Ambient Conditions sss sees nne 6 4 3 Technical Parameters snneesneenenenneeeneeenrrerrree rennene 7 4 4 Standards and CE Conformiy sss eee eee eee e 8 5 Apparatus Overview eee eee ee ee 10 OB OVSE RUNCU S rss ae 18 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG Vers 02 04 98 7 Installation and Operation 22 En Bi E E Te unseren 22 TAA Eeer EE 23 7 1 2 Electric Guppltes eee 24 7 2 ODEON raana e 25 7 2 1 Operating Prereousites nn 25 7 2 2 Operating Procedure sss sese 25 7 2 2 1 Loading the Gienltzer cesses eee 25 7 2 2 2 Cleaning of the Sterilization Material prior to EU Te tie 27 7 2 2 3 Wrapping and Loading of Sterilization Load 28 7 2 2 4 Post Treatment of Sterilization Material 31 Fe PVOGKAMS Sa ee ae ui 32 7 3 1 Program Selection Start RR 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 Heporte eee eee 36 A Ise ee 36 7 5 Automatic Safety Locke 39 7 5 1 Door Spindle
16. S isa medical device and with reference to Annex IX of the MDD to be classified as class lla medical device WEBECO GmbH amp 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 Il article 3 of the MDD reg no SY 9711455 01 On this base the small steam sterilizer WEBECO A35 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 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 A35 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 e 73 23 EEC Low Voltage Directive in conjunction with 93 68 EEC e 89 336 EEC EMC Directive in conjunction with 92 31 EEC and 93 68 EEC 8 _WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 As far as applicable for a m directives the apparatus A 35 S complies with the following standards e EN 61010 1 e EN 55011 e EN 50082 2 e EN 61010 2 041 e EN 50081 1 e 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 futu
17. The chamber is designed so that the required steam is produced in the bottom part Cooling water can be connected to the apparatus to shorten the program run up to 10 15 or when the apparatus is frequently used for example 3 times directly one after another The required dosage is automatically produced during the different phases The drying vacuum prevents from steam exhaust when the door is opened After loading the door is shut steamtight by turning the closing spindle For the sterilization process the respective program will be selected and started 18 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 The following programs may be selected Program 1 General Program for Instruments 134 C Program 2 General Program for thermolabile Instruments 121 C With program start the sterilization cycle progresses as follows a b The sterilization chamber automatically fills with a metered amount of feed water The steam created through heating up displaces the remaining air from the chamber The holding time phase commences when the operating pressure and thus the sterilization temperature provisions for saturated conditions is reached At the end of the holding time a decrease in pressure occurs and the drying phase begins supported by physical vacuum The sterilization cycle is finished by ventilation of the sterilization chamber This is visually displayed by a flashing p
18. ber with dry cloth e If necessary clean insert tray instrument dishes and lift and store in chamber Close chamber door 1 6 without applying contact pressure for transport close chamber with applying contact pressure Pack apparatus and connection pipes 40 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 7 Activating Deactivating Additional Cooling The setup procedure informs the apparatus if cooling water is connected as a supplemental cooling or not At every change of the method of operation the setup procedure has to be carried through The set up procedure is initialized if the left key 2 1 is pressed when switching on the main switch 1 2 As confirmation c is shown in the display of the residual time After releasing the key 00 or O1 is shown The meaning of the numbers is as follows 00 additional cooling off 01 additional cooling on When using the right key it is possible to switch between 0 and 1 Additional using of the left key 2 1 confirms the choice After releasing of the key the apparatus is in its normal operating condition The A35 S can work in continuos operation with or without supplemental cooling Thus the process time is shortened by approx 10 15 When working without supplemental cooling after 3 sterilizations directly after one another a reduced drying capacity or steam disturbance from the water reservoir is possible
19. ed 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 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 5 Vers 02 04 98 4 Specifications 4 1 Installation and Connection Data Dimensions heightxwidthxdepth 440x500x700mm Installation Base widthxdepth 500x550mm Chamber Dimensions diam xdepth 250x380mm Weight l ca 45kg Electrical Requirements 230V 50Hz 10A IEC 536 Protection Class Supply Connector for Cooling Water G 3 4 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 6 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 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 l electrical Heating Capacity 2 0 kW Acoustic Power Level lt 85 dB A A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 7 Vers 02 04 98 4 4 Standards and CE Conformity According to the EEC Medical Device Directive MDD 93 42 EEC the small steam sterilizer WEBECO A35
20. g Water and Condensate drain 3 1 Working with an existing drain or with an additional cooling the drain line hose with one connector G3 4 is connected at the cooling water and condensate drain 3 1 and a drain on the part of the builder Working without an additional cooling and if no drain is existing on site the drain line is connected with an optional deliverable condensate reservoir article no 03 01 53 The water level is to be inspected before every start of the program A filled up reservoir has to be changed at once otherwise the condensate reservoir might overflow The drainage pipe is to be installed as free drainage analogue dish washing machine drain or freely gt 20mm ending above gully This drain must be suited lower than the bottom of the apparatus Care should be taken to arrange the drainage hose such that no water backwash occurs IMPORTANT The working of the apparatus with the condensate reservoir is only possible without the supplemental cooling If this is not considered the condensate reservoir is overflowing c Connecting Pipes Suitable connecting pipes for supply and drainage of cooling water resp condensate are included in the delivery 7 1 2 Electric Supplies The sterilizer may be connected to a fixed socket with sealed contact for alternating voltage Electrical power 2 1 kW at 230 V AC 50Hz 24 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 2 Operati
21. 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 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 1 Vers 02 04 98 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 A35SE1 2 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG Vers 02 04 98 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 e The device shall be used only for its intended use as described by its designation and within this manual e The user shall follow strongly the advices and recommendations of this manual
22. he door can not be opened yet see also chapter 7 5 IMPORTANT The sterilization chamber is pre heated very much after a program run at 134 C At a directly following program run of thermolabile instruments 121 C the good might be damaged Please wait at least 10 minutes for cooling down leaving the chamber door open 32 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 3 2 General Program for Instruments 134 C This program is designed for sterilization of wrapped see chapter 7 2 2 3 or unwrapped solid sterilization material no narrow lumen hollow objects The sterilization time is 5 minutes ATTENTION The net loading weight sterilization goods without baskets containers etc is given for Instruments unwrapped Instruments wrapped max 3 0kg max 1 0kg This program will proceed as depicted in the following line graphic A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 33 Vers 02 04 98 A Pressure in mbar abs 3000 1013 7 2 S 2 Z or 5 a e D O FH D 5 e gt gt D Z Rad E Ka gt ec B Ss Ep ol C D O g O D Iw D ao a gt Pressure Sterilization Drying Phase Increase Sterilization Cycle 34 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 3 3 General Program for thermolabile Instruments 121 C This program is designed for the Sterilization of wrapped or unwrapped t
23. hermolabile solid sterilization material no narrow lumen hollow objects The sterilization time is 20 minutes ATTENTION The net loading weight sterilization goods without baskets containers etc is given for Instruments unwrapped Instruments wrapped max 3 0kg max 1 0kg This program will proceed as depicted in the following line graphic Pressure in mbar abs 3000 2000 Pressure Increase Holding Time 20 Minutes at 121 C Pressure Decrease Postvacuum Drying Time Pressure is att Increase Sterilization Drying Phase Sterilization Cycle A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 35 Vers 02 04 98 7 4 Notification and Failure Reports Functions and operating conditions of the sterilizer are continuously controlled by the internal computer control In case of malfunctions or deviations an alarmcode is displayed in the residual time display 7 4 1 Indications Text in Display Cause Countermeasure S A1 pressure switch cable break Notify customer defective pressure switch service defective A2 Pressure Increase too Water Shortage Refill Water long Untightness Notify customer Heating defect service Notify customer service A3 Exceeding reswitching Water Shortage Refill Water time of Heating unsuitable see Operating Element Loading Instruction chapter Too much 7 2 2 Loading Reduce Loading A4 Failure Power Supply Failure of Power Test Power Supply Supp
24. locking of Door Spindle When switching on the sterilizer or at end of one program the door interlock device system is released and the door may be opened This condition is indicated by the shining of the yellow display 2 8 INDICATION If an attempt to open the door has been made while a sterilization process was in progress please take note of the following 1 After correct program run Program End release the locking device mechanism by applying a slight turn 2 The door locking device system can then be opened as usual by turning the spindle counter clockwise A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 39 Vers 02 04 98 7 5 3 Opening the Door during Power Failure During power failure the door can not be opened because of the automatic safety lock An emergency unlocking may only be performed by the customer service or technical trained personnel 7 6 Shutdown of Apparatus 7 6 1 Temporary Standstill After the final sterilization of the day e Interrupt cooling water supply if water cooling is installed through closing of water tap e _ Switch off power supply 1 2 7 6 2 Shutdown of apparatus for standstill or transport longer standstill a few weeks Pull out plug If necessary disassemble connecting water pipes 3 1 3 2 and remove remaining water Close water inlet with lock 3 2 Turn open drainage valve 1 5 and thoroughly empty feed water reservoir Wipe out cham
25. ly existing supply voltage notify customer service ATTENTION If failures are indicated and the cause can not be rectified the appropriate customer service is to be informed CAUTION If a program ends with a failure the sterilization material is considered to be non sterile 36 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 After a failure hot water may stand in the chamber and rinse out when opening the door d Danger of burning A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 37 Vers 02 04 98 IMPORTANT If failures occur during the process a recovery program will run automatically so that the device is in a predetermined and safe operation condition and that the apparatus door may safely be opened 38 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 7 5 Automatic Safety Lock To ensure the safety of the operator the sterilizer chamber is automatically secured by a door locking mechanism The condition of this mechanism is indicated by the yellow display 2 8 7 5 1 Door Spindle Interlock At the start of a program cycle pushing the Start button 2 1 2 2 the door spindle is locked automatically In this condition the door spindle may only be turned one quarter rotation counter clockwise until the mechanism locks The door spindle is not allowed to be tightened up or further to be closed during the running program 7 5 2 Un
26. nded by the manufacturer prior to sterilization only emulgating special instrument oil may be used for the treatment of the sterilization material To avoid that oil and other contaminants from the sterilization goods drip into the dosing container a water separation system has been arranged in the apparatus i e contaminated condensate will be wasted A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 27 Vers 02 04 98 7 2 2 3 Wrapping and Loading of Sterilization Load For wrapping sterilization goods and sterilization load supply bags made from sterilization paper according to DIN 58 953 part 3 or from transparent sterilization wrapping paper and foil according to DIN 58 953 part 4 are to be used The seal seams should have a minimal width of at least 6 mm double seams are recommended Between seam and sterilization load there should be a free gap of at least 30 mm Alternatively the sterilization goods may be sterilized unwrapped in sterilization containers Using paper as sterilization wrapping keep in mind DIN 58953 part 2 The maximum load for massive wrapped instruments is 1 0 kg Instruments in sterilization wrappings are to be placed in aluminium dishes flatly on the paper side of the wrapping The wrappings may not be placed on top of each other resp they may not overlap Items with areas on which condensate may be produced are to be arranged so that accumulating condensate may drain out The
27. on 7 2 1 Operating Prerequisites Ensure that the apparatus plug is inserted into the socket Ensure that the water hoses are properly connected Switch on mains Open the water line if supplemental cooling is connected Turn the red drag pointer of the pressure gauge left to 0 Open door 7 2 2 Operating Procedure 7 2 2 1 Loading the Sterilizer The sterilization material is loaded into the chamber in sterilizing baskets trays or dishes Unwrapped solid material no hollow materials may be sterilized up to a weight of max 3kg Solid material wrapped in appropriate sterilization load wrapping may be sterilized up to 1kg max See details in chapter 7 223 to 7 225 WEBECO offers containers suitable for this sterilizer made from aluminium or baskets made from stainless steel see accessories list ATTENTION When loading or unloading the chamber the door plate and the chamber walls are preheated Do not touch these areas Danger of burning AN A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 25 Vers 02 04 98 INDICATION The height of the wrapped and unwrapped sterilization load is to be limited so that the minimal distance to the upper edge of the loading equipment or inside of the lid or stack basket on basket or bowl on bowl is at least 2cm Instruments in sterilization wrappings e g Transparent Foil Paper wrapping are to be placed in aluminium dishes flatly on the paper side
28. or GmbH und Co KG 51 Vers 02 04 98 9 Turn off apparatus after unloading it Opening of the door after switching off power supply is not possible see chapter 7 5 10 Attention Indication messages need attention although the sterilization load may be used When failures occur the sterilization load must always considered non sterile Wait always until complete automated failure recovery cycle has passed If necessary notify the customer service 52 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 WEBECO Hygiene in Medizin und Labor GmbH amp Co KG Muhlenstr 38 D 23611 Bad Schwartau Telefon 0451 2 80 72 0 Telefax 0451 2 80 72 31 2 80 72 53 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 53 Vers 02 04 98 12 Index ENEE EE deeg EE 44 Ambient Conditions eee 6 Apparatus Deseriplion nassen ern 5 Attention 1 15 18 23 24 26 27 30 31 32 40 43 REEI E ae ae Rea E en re ae 24 38 Biological Indicators unsere ee 37 38 Biological Test a 38 EI 18 32 Caution ee ee BA ee Se Bt ae de 1 28 32 42 CIE AMING Aalen teed ata tie a a 25 42 Cleaning of the Sterilization Material 25 Connection Dallas sera EH 6 e ee UE 23 28 GOING zn 15 19 20 21 22 23 28 29 35 36 DIMENSIONS EE 6 Beleg elle 34 AINA EE 10 11 15 20 44 Effectiveness Test cece occa aterm EE 37 deele ee enden 22 54 WEBECO Hygiene in Medi
29. r GmbH und Co KG A35SE1 2 Vers 02 04 98
30. re European standards for small steam sterilizers requirement levelS draft prEN 13060 1 and draft prEN 13060 4 The apparatus contains a pressure chamber of Test Group 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 AD regulations 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 TUV DB 123 01 was formally issued A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 9 Vers 02 04 98 5 Apparatus Overview 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 10 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 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
31. rogram indication 2 3 2 4 Before opening the door please ensure the pressure indicator 1 1 showing gt 0 lt bars Actual pressure and temperature values can be monitored at the different instruments 1 1 2 6 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 19 Vers 02 04 98 After starting the program cycle it cannot be interrupted Interruption of the power supply main switch 1 7 however is followed by a program break After power coming back a failure recovery program automatically is activated see also chapter 7 4 which leads to a safe system condition by which the sterilization goods can be unloaded without risk of hazard however not sterile The door can not be opened before this process see chapter 7 5 CAUTION When loading or unloading the chamber the door plate and the chamber walls are preheated Do not touch these areas Danger of burning ATTENTION Proper and safe sterilization requires an immaculate water quality for the steam generator Use only demineralized water or aqua dest 20 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 INDICATION As the connection hose 3 2 is under full pressure of the water supply whenever the inflow of the cooling water is automatically interrupted the intake line should be regularly checked to ensure its proper condition no tears proper connections Optionally a water stop device part no 02 41 73 can be p
32. rovided to be set between the raw water valve and the connecting hose to the sterilizer see also chapter 10 This is to avoid severe water damage due to burst hoses IMPORTANT After completion of the last sterilization process of the day the apparatus and if cooling water is used the water are to be turned off A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 21 Vers 02 04 98 7 Installation and Operation 7 1 Installation The installation of the apparatus should be performed by two persons who grip lateral under the apparatus for carrying The location for the A35 S may be freely chosen The location of the device has to provide a horizontal surface To avoid infringement of the device by heat stagnation care should be taken for free ventilation of cooling air for access below the bottom plate and escape from the top of the back plate when emplacing the unit The apparatus is specially designed to ensure a steam free working environment A Drainage steam line is not necessary If cooling water is used however the chosen location must be able to facilitate a cooling water intake and drainage pipe connection with the apparatus For the working of the device without the supplemental cooling water intake a condensate container is available part no 03 01 53 It is used for the condensate which obtains during the sterilization process 22 WEBECO Hygiene in Medizin und Labor GmbH und Co KG A35SE1 2 Vers 02
33. st by according if required manufacturer or to Chapter every year customer service 9 1 replacing of seal according if required by user person in to chapter every 2 years charge of 9 5 equipment or customer service complete overhaul by manufacturer or customer service Entire apparatus Chamber door Entire apparatus every 5 years A35SE1 2 Vers 02 04 98 46 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 9 3 Cleaning Wipe out chamber with moist cloth and dry Clean insert tray and instrument dishes with a wetting agent rinse off with clean water and dry 9 4 Repairs 1 Empty the clean water reservoir 1 5 by turning the drainage valve If the reservoir contains residue it is to be cleaned prior to the new fill Depending on residue a cleaning or fat dissolving agent is to be used which then is to be thoroughly rinsed off CAUTION Disconnect power supply prior to cleaning Grease spindle at the rotary closing device Remove old fat rests from the spindle then grease spindle with high melting point grease Replace aeration filter Switch on the unit and open the door Remove filter and replace with new filter part no 02 31 79 Close the door and switch off the unit again A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 47 Vers 02 04 98 4 Replace door seal e Switch on the unit and open the door e Remove door seal from the groove on the inside
34. zin und Labor GmbH und Co KG A35SE1 2 Vers 02 04 98 Falllke Eege EE ER Feed Water Hesenvoir cc eee 11 35 IMPONA 2 19 21 22 27 29 33 36 WICH CANON EE 1 2 24 28 NSU OMA cee eter there ed et aan ected Ee Buc te 6 20 Insirumente cc ee 13 17 24 26 29 30 31 Juge e le EE 18 Loading asia 23 26 32 e e ele EE 4 40 41 later TEE 5 14 Net Loading Weight sees eee 30 31 OM MSA a1 eege ed 25 Operating Prerequisites e eee eee 23 Operation ia 6 10 12 20 23 36 45 GE on af gr e 1 Pressure Chamber ale 7 Program SCC CUO EE 29 PROGINS Se EE 17 29 38 QUICK GUIDG rear 10 45 Recovery Program anne are 18 33 References to Ilustraton nn nenn nennen 2 A35SE1 2 WEBECO Hygiene in Medizin und Labor GmbH und Co KG 55 Vers 02 04 98 PRS US E 40 42 Salely IMGICATONS susanne 3 Sale LOCK rain 34 SEIVIce seele seine 4 Shutdown of Apparatus e sse eee eee eee 35 opare EE 44 SDECIICANONS hice elite 6 eelef Lee ernennen 8 EE Heger 35 Sterilization Of Be Ris sidis ressidar ea 24 System Lee EE 16 Table GrG OMENS esenea a aE Technical Parameterg eee ee eee 7 Thermoelectric Measuremente ee ee ee ee e ee e e 37 E sess erecta aces alates Nile he DS oe are Si ee ae aR tea 12 13 DR EE 44 Walter TE T ont tia tte ta eet Sanco 18 Water ee E 15 21 Weight ss een 6 WF ADDING 2s eebe 23 24 26 27 38 Wrapping and Loading of Sterilization Load 26 56 WEBECO Hygiene in Medizin und Labo
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