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User's manual MST-V_CB_V29 - Frank's Hospital Workshop

1. CAUTION Keep the movement area of the door unobstructed during door opening and closing 6 8 1 Unloading sterilizer e Open the chamber door by pressing the open door button e Align the front end of the transfer carriage with the end of the sterilizer refer to Figure 6 6 e Move carriage forward until lever latches with lock bolt e Verify that transfer carriage is latched with chamber by pulling transfer carriage backwards transfer carriage must remain stationary e Carefully pull the loading cart from chamber onto transfer carriage until transfer carriage latch engages to loading cart e Disengage transfer carriage e Push transfer carriage in chamber direction e Pull transfer carriage unlock lever e pull transfer carriage away from the sterilizer chamber e Close the chamber door by pressing the close door button User s Manual Page 35 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 6 9 Cycle documentation At cycle end the cycle documentation is printed on the built in printer refer to Figure 6 12 The Panel Mount printer uses impact dot matrix technology For a detailed description of the printer see instructions in chapter 5 5 For printout examples see in chapter 5 6 Figure 6 12 Built in printer 6 10 Log off After using the sterilizer the user should log off to prevent that unauthorised persons can handle the Sterilizer Press first the menu button o
2. Set Values Leak rate 1 3 mbar min Test time 15 0 min Time Phase Press Temp mis mbara C 0 00 Vacuum 995 28 5 2 20 Stabilize 70 25 5 7 20 Air Leak Test 72 27 9 22 20 Air Break 79 28 3 24 03 Complete 980 29 1 Leak rate 0 5 mbar min CYCLE PASSED Cycle approved Y N Date Signature Figure 5 9 Printout of a Leak Test cycle General Specifications impact dot matrix 42 columns 57 5mm Paper roll diameter 38mm User s Manual Page 25 of 99 User s manual MST V_CB_V29 doc Revision 11 June 2008 Belimed Sauter AG 5 7 Door operation The doors of the Belimed Steam Sterilizer TOP 5000 are motorized they can be activated by pressing the control buttons open door and close door on the control panel of the operating or non operating end the corresponding door will be activated when the sterilizer status allows the opening or closing procedure The door motor is equipped with a safety clutch which stops the door if the closing force is gt 150N 2 Fabric packs 134 C 3 4 Rupper 121 C Warm up amp Leak Test 1 5 Bowie Dick Test close door cycle start i open door ER ES EJ Figure 5 11 Door operation buttons non operation end User s Manual Page 26 of 99 User s manual MST V_CB_V29 doc Revision 11 June 2008 Belimed Sauter AG 5 8 General precautions for the sterilization procedure The sterilization performances in terms of cycle duration level of dryne
3. User s manual MST V_CB_V29 doc Belimed Sauter AG
4. e Chamber pressure P1 e Chamber temperature T1 e Cyde graph e Cycle status phase e Cyde intervention button e Menu button Figure 6 10 In cycle display 6 7 Cycle failed If there was an injurious alarm during a cycle the door on the non operating end is locked On the operating end panel the message cycle failed is displayed refer to Figure 6 11 If the user must press the ok button Only the door on the operating end can be opened Unload the sterilizer The load must be wrapped again with dry material before sterilizing Figure 6 11 Cycle failed display User s Manual Page 34 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 6 8 Unloading the sterilizer WARNING BURN HAZARD Sterilizer and rack shelves will be HOT after cycle is run Always wear protective gloves and apron when removing a processed load Protective gloves and apron should also be worn when reloading sterilizer following previous operation WARNING FALL HAZARD To prevent falls keep floors dry by immediately wiping up any liquids or condensation in sterilizer loading or unloading area The door on the non operating end double door sterilizers can be opened if e The sterilization cycle is completed Test cycles door can be opened on the operating end only e The cycle passed no injurious alarms during cycle e The difference between chamber pressure and atmospheric pressure does not exceed 80mbar
5. 60 F Option cooling water circuit 101 101 VE Deionised water 15 80 C 2 5 e 0 1 m h 201 2 5 y 0 1 m h 261 for internal steam generator only Conductivity gt 1uS cm and lt 15uS cm DL Compressed air oil free 5 7 Y 5Nm h 03Nm 5 7 Y 5Nm h 0 3 Nm EL1 Electric supply external steam 4A 17kW 0 5 kWh 6A 26kW 0 9kWh 3N 380 400V 50 Hz 104 104 EL1 Electric supply intern steam generator 83A 56 kW 15 kWh 94A 65 kW 19 kWh 100A 100A 3N 380 400V 50 Hz ZL Air inflow to service room coming through customer s ventilation duct or from operating room Standard Waste line ALP Free air exhaust of vacuum pump A Floor drain waste water open 1s max 20 1 max 25 l min l min GU Floor drain 2 2 ALT Air outflow from service room 2 kW 3kw heat flow of 1 kW to be dissipated temperature in service room 30 C Option waste steam line upwards AD1 Waste steam chamber max 2 7 1 nipple 240 kg h max 2 7 1 nipple 240 kg h AD2 Waste steam jacket max 2 7 1 nipple 240kg h max 2 7 1 nipple 240kg h AD3 Waste steam steam generator max 2 7 1 nipple 290 kg h max 2 7 1 nipple 290 kg h Option Cooling water circuit KWV Cooling water forward 2 5 Y 2m h Discharge 2 5 Y 2 5 mh discharge o 6001 800l E AT 19K 36000kJ 45000kJ Cooling energy required 12kW 16kW KWR Cooling water backward Y Y Additional information Batch time by full charging EN 285 i textiles ca 45 min texti
6. Baskets of instruments together Rubber goods together Goods to be sterilized shall be packaged in a loose way Sufficient room shall remain free in order that the steam can reach the surface of the goods to be sterilized without hindrance Keep at least 5 cm 2 distance horizontally and vertically between the goods to be sterilized and the chamber walls Insure that the goods to be sterilized are placed in a stable way on the transportation cart and that they can t move or fall down during the process Open containers cups and tubes shall be placed in such a way that the condensed water will easily drain User s Manual Page 27 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 6 Operating the sterilizer 6 1 Turn on the sterilizer The Main power disconnect switch refer to Figure 6 1 is located behind the access door on the main control box This switch disconnects power to the control Under normal operation this switch is left in the On position at all times The Steam shut off valve refer to Figure 6 1 is located behind the access door on the top Ensure this valve is in the open position before trying to operate the sterilizer The Tap water shut off valve is located behind the lower maintenance door Ensure this valve is open The Deionized water shut off valve option internal steam generator is located behind the lower maintenance door on the left side Ensure this valve is in the open p
7. The gauges shall show Pressure indication Nominal conditions Maximum conditions bar bar Steam supply 2 5 3 2 5 3 5 Chamber 0 96 2 3 1 42 7 Jacket 0 96 2 3 1 42 7 Door seal door locked 2 9 3 2 2 8 3 5 Compressed air 5 7 5 7 Tap water 2 5 2 5 Deionised water 2 5 1 5 5 Table 5 1 Pressure indicators in service area 7 Tap water pressure gauge co Deionised water for optional steam generator Compressed air gauge Figure 5 3 Instrumentation User s Manual Page 22 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 5 3 Operating End Control Panel Figure 5 4 shows the arrangement of the control elements on the operating end The user s control panel with the interactive touch screen display is described with more details Figure 5 5 and Figure 5 6 hereafter The chamber temperature indicator can be configured in F or C The chamber pressure indicator can be configured in mbara barg kPaa psia psig in Hg Figure 5 4 Operating end control panel 2 Fabric packs 1349C 3 4 Rupper 1219C Warm up amp Leak Test 5 Bowie Dick Test oS ber Figure 5 5 Out of cycle display Figure 5 6 In cycle display m intervention User s Manual Page 23 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG
8. 5 4 Non Operating End Control Panel option Sterilizers with 2 doors are equipped with the non operating end control panel Figure 5 7 shows the panel on the non operating end Figure 5 7 Non operating end control panel No ltem Name Function 1 Push button Open door Open chamber door at end of cycle 2 Pushbutton Close door Close chamber 3 Push button n a 4 LED Open door Lights up when the door on the non operating end can be opened 5 LED In cycle Lights up while a cycle is running 6 LED Door locked Lights up when doors are locked 7 LED Alarm Lights up while an alarm is active 8 Bar Graph Cycle progress Shows the progress of a cycle 0 100 9 Display Temperature Chamber temperature Indicator or remain process time 10 Display Pressure Chamber pressure Indicator 11 Push button Emergency stop Emergency stop button User s Manual Page 24 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 5 5 Printer The cycle documentation printer is a panel mount printer refer to Figure 5 8 Technology Columns vr mem B Paper with nese Figure 5 8 Panel mount printer For replacing paper roll or ribbon refer to chapter 11 5 6 Printouts example BELIMED CYCLE DOCUMENTATION Hospital Charity Department CSSD Machine Type 12 6 12HS2 No 045556 Run number 345679 Operator Brown Cycle 4 Leak Test Version PR 13 03 2001 SW 2 2 Cycle start 24 03 2001 13 35
9. Manual User s manual MST V_CB_V29 doc Page 10 of 99 Revision 11 June 2008 Belimed Sauter AG 3 2 Required building system utilities Unless otherwise specified in the contract the utilities refer to Table 3 2 to Table 3 3 must be provided by the customer to the connection points refer to Figure 3 1 3 2 1 Utility connections Model 6 6 6 VS1 6 6 6 VS2 6 6 9 VS1 6 6 9 VS2 KE EE v 9 3 8 ES TEC ES st 3 2 Z S a8 2 7 2 z c A 9c c A 2 e S BE m 3 BE al E 3 5 52 5 5 52 E 3 ese E 2 a ze a S amp fe Ss amp fe OS Standard Supply lines SD Sterilizing Steam 2 5 3 Y 50 kg h 13 kg 2 5 3 Y 60 kg h 16 kg KW Tap water for vacuum pump 15 C 2 5 Y 1 m h 1901 2 5 y 1 2m h 2801 60 F Option cooling water circuit 101 101 VE Deionised water 15 80 C 2 5 Y 0 1 mh 141 2 5 Y 0 1 m h 171 for internal steam generator only Conductivity gt 1uS cm and lt 15uS cm DL Compressed air oil free 5 7 Y 5Nm h 03Nm 5 7 Y 5Nm h 0 3 Nm EL Electric supply external steam 4A 1 7kW 0 5 kWh 4A 1 7kW 0 6 kWh 10A 10A 3N 380 400V 50 Hz EL Electric supply intern steam generator 48A 32kW 10 kWh 69A 47 kW 12 5 kWh 50A 80A 3N 380 400V 50 Hz ZL Air inflow to service room coming through customer s ventilation duct or from operating room Standard Waste line ALP Free air exhaust of
10. Times are displayed in tenths of a minute In a third screen a complete program can be copied under a new number copy program Figure 9 41 Copy program display Guidance to copy a program 1 Select the program to be copied See chapter 6 4 2 Select a cycle 2 Enter the number of the new program in field new program number Warning Any existing program under that number will be overwritten 3 Press copy program button to copy the program To modify the program name and parameters the new program needs to be selected User s Manual Page 88 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 10 8 PLC functions The PLC functions allow the Belimed maintenance personnel to read any data from the PLC Warning Write entries are allowed only to Belimed maintenance personnel who are authorised by the sterilizer manufacturer The functions and addresses must be announced by the manufacturer before The Belimed maintenance personnel has access to the PLC data memory refer to Figure 9 42 databit Figure 9 42 PLC functions Reading a value from PLC e Select the data type e Enter the PLC memory address and DB No e Push button read value Change a value in the PLC e Read the value you want to change as described above e enter the new value in the field value e Press button write value The new value is displayed on the left side User s
11. User s manual MST V CR V29 doc Belimed Sauter AG Step 4 Place the cover back in its position Introduce the paper from the back side through the cover Place the cover on the housing with a distance of about 1 cm from the edge and shift it as far as it goes Figure 11 9 Figure 11 9 Printer place the cover back 11 2 Cleaning of Chamber and Front panels Clean chamber and front panels if dirty but at least once per week WARNING Before entering the chamber e g for cleaning turn the key switch off position 0 and keep the key in your pocket as long as you work in the chamber CAUTION Clean the chamber in cold condition only Chamber Clean with cotton towel or sponge Use water or washing up liquid See to it that no residues are left Front panels Clean with soft towel Clean dry or use washing up liquid or stainless steel cleaner EAB TOP Belimed part no 3 175 User s Manual Page 95 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 12 List of Figures Figure 3715 DICO A A A AAA A AA A A 13 Aa O ee a 16 Figure 4 1 Chamber labelling example 18 Figure 4 2 Lab elling Electrical RM e eG aed oa 18 Figure 4 3 Label DANGER OF SCALDING accedit doa orat b e e iia oe 19 Figure 4 4 Label Danger overpressure ee ee AA 19 Figure4 5 Label DANGEROUS VOLTAGE te et SA ee 19 Figure 4 6 Label Danger of squeeze hand while closing chamber door 19 Abla
12. cycle user ad intervention batch data Figure 9 26 Menu display Press maintenance button The following functions can be selected refer to Figure 9 27 e Replace door seal at operating end access level 3 e Calibrate touch screen access level 3 e Calibrate sensors access level 5 e Machine set up access level 5 e Maintenance intervals access level 5 e Printer self test access level 5 e Cycle parameters access level 5 e PLC functions access level 5 e O Test Level 5 e Air Detector option access level 5 calibrate sensor door seal touch screen adjustment machine maintenance printer set up interval self test cycle PLC a Figure 9 27 Maintenance menu display User s Manual Page 78 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 10 1 Replace door seal The maintenance personnel can replace the door seal on the operating end by pressing replace door seal button while the chamber door is open refer to Figure 9 28 Press blow out door seal button to remove door seal on the operating end Press pull back door seal button and the vacuum pump sucks a vacuum behind the door seal Press standby button to set the sterilizer to initial load position Press complete button to set the sterilizer to complete unload position to replace the door seal on the non operation end For replacing the door seal refer to main
13. docu TB side 2 automatic Figure 9 9 Set up display User s Manual Page 64 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 4 1 Early start night time shutdown Press early start night shutd button The display shows the input mask refer to Figure 9 11 P1 chamber T1 chamber status door locked E night time shutdown pro g NO BE Figure 9 10 Early start night time shutdown display Night time shutdown If you press night time shutdown button the sterilizer goes into a sleep mode at the end of the next cycle All valves are closed an optional connected steam generator is turned off To restart the sterilizer turn key switch off and on again Early start Conditions for early start The Sterilizer must be in the initial position and the chamber doors must be closed If you want to start a cycle early in the morning usually the warm up and leak test cycle set early start date and time enter prog no and activate early start button left side With the keys and the starting date can be selected gradually The sterilizer goes into a sleep mode the display is turned off At the pre set early start time the sterilizer goes into an active mode the operating panel display is turned on and the pre selected cycle starts The system suggests the date of the next day and the last pre set time If the sterilizer is in sleep mode early start or n
14. in the sterilizer refer to Figure 9 7 Figure 9 7 Readings display P1 Chamber pressure control P2 Chamber pressure documentation P3 Jacket pressure P4 Steam supply pressure T1 Chamber temperature control T2 Chamber temperature documentation T3 Air detector temperature option T4 Condenser temperature chamber outlet cooling T5 Circulation tank temperature vacuum pump cooling User s Manual Page 63 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 4 Set up Press menu button The menu functions are displayed refer to Figure 9 8 pura readings S print last cycle SS cycle user ad intervention Pah data ministration maintenance Figure 9 8 Menu display Press set up button The display shows the set up functions refer to Figure 9 9 e Early start and night time shutdown access level 1 e Set clock access level 2 e Select Language access level 1 e Steam generator on off access level 1 if steam generator connected e Drain steam generator access level 2 option internal steam generator e Configure cycle selection access level 2 e Set screen contrast access level 1 e Activate on line documentation e Automatic loading unloading device on off access level 1 option early start set FEOS night shutd clock guag steam config cycle contrast generator selection sr j drain steam TB side 1 online generator automatic
15. personnel and CAUTIONS indicate the potential for damage to equipment The precautions may be repeated where applicable throughout the manual The following is a list of all safety precautions to be taken Carefully read them before proceeding to use or service the unit WARNINGS e BURN HAZARD The chamber door surface can be hot gt 70 C 158 F if the ambient temperature is above 30 C 86 F e BURN AND SHOCK HAZARD Repairs and adjustments should be attempted only by authorised persons fully acquainted with this equipment Use of inexperienced unqualified persons to work on the equipment or the installation of unauthorised parts could cause personal injury or result in costly damage e Observe the label Dangerous voltage turn off main switch before opening e BURN HAZARD Allow sterilizer generator if applicable and accessories to cool to room temperature before performing any cleaning or maintenance procedures e This sterilizer is not designed to process liquids e BURN HAZARD Sterilizer and rack shelves will be HOT after cycle is run Always wear protective gloves and apron when removing a processed load Protective gloves and apron should also be worn when reloading sterilizer following previous operation e FALL HAZARD To prevent falls keep floors dry by immediately wiping up any liquids or condensation in sterilizer loading or unloading area e EXPLOSION HAZARD This sterilizer is not designed to process flammable liqui
16. pre sterilization test pack weight and the pack must not exhibit wet spots Wrapped instruments Upon completion of the recommended cycle the wrapped instrument pack must have no wet spots on the outer wrappers Moisture retained in the load must cause no more than a 0 2 increase in pre sterilization weight 8 2 3 2 Summary e External droplets or visible moisture on the exterior pack or on the tape are unacceptable unless the wrap is completely impermeable to water Note This should be inspected while unloading the sterilizer e Water droplets on the interior of a wrap or on the items within the pack are unacceptable e A pack is unacceptable if the pack is damp or wet when opened for use e A general guideline is that the pack be completely dry after cooling to room temperature i e 21 C and 50 relative humidity for a minimum of one hour following unloading from the sterilizer 8 24 Solving wet pack problems If moisture is detected on the interior of the wrap in the huck towel or on the item the causes can be e Insufficient drying time e Chamber overloaded size density or weight of specific packs e Excessively large hard goods items being sterilized e No absorbent huck towel used e Materials not being permitted to cool and equilibrate to room temperature e Wet steam supply e Defective vacuum drying system e Airleak User s Manual Page 55 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belim
17. the entry field for the password refer to Figure 6 4 User s Manual Page 29 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG Figure 6 4 Log on display To enter a password press the field below password The alphanumeric keyboard is shown refer to Figure 6 5 EE A II aa75g4 s css2 537 E GEI a ll Figure 6 5 Alphanumeric TER Enter the password and press the J button After entering the Password press the Login button Figure 6 4 You will see message Invalid Password if you have entered an incorrect Password If the Password is correct the display switches to the Menu display User s Manual Page 30 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 6 3 Loading the sterilizer WARNING BURN HAZARD Sterilizer and rack shelves will be HOT after cycle is run Always wear protective gloves and apron when removing a processed load Protective gloves and apron should also be worn when reloading sterilizer following previous operation WARNING FALL HAZARD To prevent falls keep floors dry by immediately wiping up any liquids or condensation in sterilizer loading or unloading area Prepare the load as described in chapter 8 Techniques of sterilization CAUTION Keep the movement area of the door unobstructed during door opening and closing 6 3 1 Loading sterilizer If you want to enter batch data manually select
18. to push gasket into groove CAUTION Never use wire brush or steel wool on door and chamber assembly CAUTION Observe the Electrostatic Precautions outlined in the maintenance manual Always wear a grounding wrist strap when removing or replacing PC boards or ICs CAUTION Solenoid valves are equipped with a special material which can be attacked by oils and grease When replacing entire valve wipe threads clean of cuttings oils and use Teflon tape to seal pipe joints CAUTION Handle siphon and bellows assembly gently to avoid damage CAUTION Keep the movement area of the door unobstructed during door opening and closing CAUTION Any alteration of the sterilizer which affects its operation will void the warranty and could violate state and local regulations and jeopardise insurance coverage CAUTION Use only original BELIMED replacement parts for maintenance purposes in all other cases the manufacturer can no more guaranty the specified performances of the equipment nor apply the warranty conditions CAUTION In order to ensure the proper function of the sterilizer run a vacuum leak test cycle daily CAUTION The Bowie Dick Test Cycle has to be performed daily CAUTION Sterilize only goods which are declared to be steam sterilisable by their manufacturer and compatible with the chosen cycle parameters maximum temperature CAUTION Respect the maximum number of sterilisation s given by the manufacturer of the goods to be ste
19. 05 660 x 660 x 700 1970 x 980 x 960 1040 700 780 1000 6 6 6 VS2 2 doors 4 305 660 x 660 x 700 1970 x 980 x 960 1040 750 830 1050 6 6 9 Ve 1 door 6 440 660 x 660 x 1000 1970 x 980 x 1260 1340 800 910 1240 6 6 9 M52 2 doors 6 440 660 x 660 x 1000 1970 x 980 x 1260 1340 850 960 1290 6 6 12 VS1 1 door 8 565 660 x 660 x 1300 1970 x 980 x 1560 1640 900 1040 1465 6 6 12 VS2 2 doors 8 565 660x660 x 1300 1970 x 980 x 1560 1640 950 1090 1515 6 6 18 VS1 1 door 12 880 660 x 660 x 2000 1970 x 980 x 2260 2340 1100 1240 1865 6 6 18 VS2 2 doors 12 880 060x660 x 2000 1970 x 980 x 2260 2340 1150 1290 1915 1 without with control panel above chamber 2 Weight with internal steam generator 3 1 Sterile unit H x W x D 300x600x300mm Table 4 1 Size and Designation User s Manual User s manual MST V_CB_V29 doc Page 17 of 99 Revision 11 June 2008 Belimed Sauter AG 4 2 Marking The sterilizer can be identified through following two metal marking plates e Chamber jacket ratings Figure 4 1 are located just above the chamber door on the operating end sees BELIMED Ic 0036 A J Year of eng anno ai vost Raum Weepece 1 spece Veenema 1 terercaran amissiblie intaht vohume Fr fdnrek Presoten d esonl test pressovre prnsstone di prova PT bar Patur dato dato data Figure 4 1 Chamber labelling example e Electrical ratings Figure 4 2 are given o
20. 11 2 Replace ribbon eo te do 93 Emtee Replace ribbon tdSSElte 2 uec cs oie eb te dr eene e bate dete deti a 93 Figure SA Replace OR 93 Figure 11 5 Replace paper roll deer uS foa oct sia tlc IC ec AO 94 Figure 1162 Replace paper toll AMA 94 Eemere DEE eer dates tei ind evsulvdem dete tote deeg 94 Figure 11 8 Replace paper roll 4 hsc ameti tasa Gro tal 94 Figure 1 1 9 Printer plate the cover Dackcs enee 95 User s Manual Page 98 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 13 List of Tables Table IZA it A A A A cti A e tied 10 Table 3 2 Utilities for chamber size 6 6 6 10 00 0 oa 11 Table 3 3 Recommended feed water quality for sterilizers sss 15 a AAA A DU Ne 17 Table 5 1 Pressure indicators in service o aes 22 Ee 38 Table edu e A estu pute dI ue TA 40 Table 7 3 Ee gs oen abiens o O a fe LEE Due 41 IA e re Ca UAE IUE 42 Table 7 5 134 C Warm up amp Leak Test le Ee 43 Fable 726 E a AA A 44 EI E PA A A E EM EI CE 45 Table 7287 134 C Heavy Instr rmgrits Cycle Geesen ee easet tete esee ie eee eee ea ttes 46 Table 7 9 125 C Porous koad eyele aesti il 47 Table 7 10 121 C e e LLL LI I DEDE 48 Table 8 T Recommended Solid RE 53 Table 6 2 Recommendedsolidload co S Sd e E Us 53 Table 9 1 User menus and TOMS e Gate ele aa ds dao 59 A II Dt teu d ptt ts 73 Table 9 3 Ambient pressure Tor altitudes up to 2200m ia 80 User s Manual Page 99 of 99 Revision 11 June 2008
21. 8 User s manual MST V CB V29 doc Belimed Sauter AG 7 9 134 C Bowie Dick Test No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME Bowie Dick Test 134 C 1 Bowie Dick Test Pack Table 7 6 Bowie Dick Test cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 Bowie Dick Test Cycle 134 C P A Figure 7 7 Cyde Graph 134 C Bowie Dick Test cycle CAUTION The Bowie Dick Test Cycle has to be performed daily User s Manual Page 44 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 7 10 Leak Test Cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME LEAK TEST EMPTY CHAMBER max Leak rate 1 3mbar Min Table 7 7 Leak Test cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 Leak Test Cycle P 2 1 0 gt t 1 Figure 7 8 Cycle Graph Leak Test cycle User s Manual Page 45 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 11 134 C Heavy Instruments cycle CVELE STERILIZE STERILIZE RECOMMENDED LOAD TEMP TIME TIME Heavy 134 C 5 minutes 11 min Heavy instruments in stainless steel Instruments 3 containers 134 C max 14kg container gross weight Table 7 8 134 C Heavy Instruments cycle The cycle graph provides a visual representation of the Belimed Steam Ster
22. Belimed Infection Control Belimed Steam Sterilizer MST V TOP 5000 USER S MANUAL Model 6 6 6 VS1 VS2 660 x 660 x 700 mm Model 6 6 9 VS1 VS2 660 x 660 x 1000 mm Model 6 6 12 VS1 VS2 660 x 660 x 1300 mm Model 6 6 18 VS1 VS2 660 x 660 x 2000 mm Table of contents 1 Limitation of liability and indemnity eese 5 25 lntrodU EE 6 2 1 Become familiar with the SyStem acu acis bdo e het dades e EHE Ei eut land 6 22 IE US 6 237 SUMMMALY Ol safety precocidad 7 cu UE E 10 E Cuba CORO O Un OP ee 10 3 2 Required building system DEIER 11 32 Atilio connections mena A A aif nud 11 3 2 2 BODEN EE 13 3 3 Installation O 14 e a joo o nouerit A E nO A 14 E ele Lo ispre eea aee a eE ea Ae Teaia EEEE REEE EEEE 14 Gelee 14 30 Utility senice requerida 14 O 16 An Label ere ers irr eer tira ster ier sere es Ain nae Ina lI ences er tee 17 AEA Type ANC Mod l DESIG EE 17 21 2 Md 18 43 Waming EI GE 19 5 General description of the components and functions EE 21 A A P 21 OO 22 A abt raat earn aua na EN MEUM etch 23 5 4 Non Operating End Control Panel ODUOFI anno 24 So y PNE e ii 25 Se Printouts example aesa Sty eat nS San ings 25 a Ddr se rco TN re rcc 26 5 8 General precautions for the sterilization procedure s s ss ssesresresissesresresnrerresresrrresresrsrenrens 27 6 Operating the Sterilizer aca 28 Sch TU ita 28 OZ LO ONT sagas xsd ot nde wand bte te
23. Bu A ZAP act ce aeris A A LL Rua Ss dk a 20 Figure 4 8 Label CAUTION REFER TO MANUAL x atte e e ee eden 20 Figite 5 T Controlelemerits operating ende es ea aa bl 21 Figure 5 2 Control elements non operating end 21 Figura 5 3 Instr lientaltlOrT s sciet eese tete ene ia 22 Figures Operating end Bereet E 23 Figure 5 5 Out of cycle display ceat tetas eer erte eet 23 Figure 5262 Ihscycle di Aaa 23 als E 24 Figure 5 8 Panel mount printer AAA A AA E AE 25 Figure 5 9 Printeutora Leal LAA A tede Dette A oe 25 Figure 5 10 Door operation buttons operada ii 26 Figure 5 11 Door operation buttons non operation end 26 EICH Utility locati E 28 Oo ad layer st eae ance et het wane A ona EE 29 Figure 6 3 Menu display cc aec See ea A A Sok A Ee 29 Figure 6 4 Og Bel e 30 Eemere o alia 30 Figure 6 6 Align transfer carriage with chamber 31 Figure 6 7 Loading Stenilizel zap ee nage AN he eh uie Ne a 32 Figure 6 8 Cycle selection buttons with cycle Start de 33 Figure 6 9 Cycle selection with dialog AAA Ee 33 EU O ee 34 Figure 6 11 Cveletall Bc displayi a aa AA 34 Figure 6 12 Built in a AAA A A nenne 36 AM enau a emt e 36 Figure 614e cycleinterventiondis e tet bt ve aw us 37 Figure 7 1 Pre treatment FRVV AAA ad el Se dh Sd el 39 Figure 7 2 Pre treatment FRVV with Air Detector option 39 Figure 2 3 CucleGraph e is AA 40 Figure 7 4 Cycle Graph 134 C Porous load ode 41 Figure 7 5 Cycle Graph 2912 EENEG ee 42 User s Manual Pa
24. Manual Page 89 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 10 9 I O Test The Belimed maintenance personnel can read the digital PLC inputs for diagnostics and wiring tests He also can temporary set an digital output refer to Figure 9 43 Leaving the Mask resets the manual set outputs Reading a digital input from PLC e Enter the Input byte address in the field input byte Values with 24V are displayed High with green background Writing a digital output e Enter the output byte address in the field output byte e Select the desired bit in the lower row The button changes to high with green background e Push the write outputs button The corresponding output is set Warning Digital outputs are set without any conditions not limit switches are checked The outputs stay set until a reset command is set or the mask is closed Only the emergency stop button stays in action o Big ii ow Low tow Low iow Cow Low Low ow tow tow tow Low write outputs Figure 9 43 O Test User s Manual Page 90 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 10 10 Air Detector Adjustment optional The following settings can be made for the Air Detector option Air Detector inactive Monitoring of the Air Detector can be deactivated by pressing this button for a batch The documentation is created with n
25. T V_CB_V29 doc Belimed Sauter AG The second display refer to Figure 9 30 functions are e The low steam pressure alarm delay time can be set default 300s e Pressure difference between set steam pressure and alarm pressure default 500mbar e Steam set pressure in out of cycle position default 3900mbar e Steam set pressure in cycle default 700mbar above chamber pressure during sterilize phase Figure 9 30 Machine set up display 2 e The third display refer to Figure 9 31 functions are The compensation time before the sterilization is started can be set default 4 seconds e The control temperature of the circulation tank default 40 40 C e the control temperature of the circulation tank during vacuum steps prevac dry default 21 30 C e The control temperature of the condenser if the chamber pressure is gt 500mbar default 50 30 C e The control temperature of the condenser if the chamber pressure is 500mbar default 35 15 C without with cooling water loop Figure 9 31 Machine set up display 3 User s Manual Page 81 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG e The fourth display refer to Figure 9 32 functions are The system can request batch data before a cycle is started e A buzzer can be activated at an incoming alarm until alarm is acknowledged e A buzzer can be activated at cycle end until a chamber door is opened e Display mode The remain p
26. UMMARY OF THE SAFETY PRECAUTIONS TO BE OBSERVED WHEN OPERATING THIS EQUIPMENT CAN BE FOUND ON PAGE 7 OF THIS MANUAL AND BEHIND THE SERVICE DOOR OF THE UNIT DO NOT OPERATE THE STERILIZER UNTIL YOU HAVE BECOME FAMILIAR WITH THIS INFORMATION Manufacturer Sales and Service Belimed Sauter AG Zelgstrasse 8 CH 8583 Sulgen Switzerland Phone 41 71 644 85 00 Fax 41 71 644 86 01 User s Manual Page 5 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 2 Introduction 2 1 Become familiar with the system This manual contains important information on proper use and maintenance of this sterilizer All operators and departments heads are urged to carefully review and become familiar with the warnings cautions and instructions contained herein This sterilizer is specifically designed to process goods using only the cycles as specified in this manual If there is any doubt about a specific material or product contact the manufacturer of the product for the recommended sterilization technique 2 2 Intended use The Belimed Steam Sterilizer TOP 5000 is designed to be used for the terminal sterilization of porous and non porous heat and moisture stable materials in the healthcare facilities The sterilizer is factory equipped with standard cycles their applicability is insured only under the specified conditions Depending of the chosen cycle materials as different as textiles glassware unwrapped or wrapped in
27. a dada dara alada dada dez 78 910 1 Replace door gie EE 79 9 10 25 Calibrate Ne 79 LA El aa a aa aaa a a andes 79 910 4 Machine Set e 80 DE MERCI geen 85 A tegt degt 86 9 10 7 Modify Cycle Parameters and copy program risa 87 9 10 83 y 89 A na ee LS LR ne ner a a a S MN a 90 9 10 10 Air Detector Adjustment optional rimar daa 91 10 ROUtINE Monitorings ii aan 92 UR eelere We dei le 92 10 2 Testing for pre vacuum SAI GIEM CY ces metere ttu rini stet epu shod saoh cnc teicioiinin tocaba 92 AE NIE quc eee EE ee 92 10 2 2 BOM DI e 92 11 Routine MaldtendNCE ii ias 93 11 1 Replacement of ribbon or paper rolls da 93 11 2 Cleaning of Chamber Ee 95 12 EES ea AC P T 96 13 A sv 99 User s Manual Page 4 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 1 Limitation of liability and indemnity In no event whether as a result of breach of contract warranty or tort including negligence and strict liability shall Belimed Sauter AG or its suppliers be liable for any consequential or incidental damage including but not limited to loss of profits or revenues loss of use of the Products or any associated equipment loss of the Buyer s Products damage to associated equipment cost of capital cost of substitute products facilities service or replacement power downtime costs caused by such Products or claims of the users for such damages Buyer and ultimate user hereby agree to indemnity Belimed Sauter AG and to hold B
28. a huck towel Open towel to fully cover the metal surface Arrange utensils so that the bottom of each is parallel to the one beneath it This allows air to escape from the utensils and helps drying Place internal chemical indicator in an area of the package where steam penetration is worst Ink side should not come in contact with metal surface Wrap utensils sequentially in two wrappers refer to Figure 8 2 Secure with sterilizer tape and identify Recommended weight of each wrapped utensil set is 6 8 kg for minimising moisture retention Note Wrapper size should be adequate for the desired method of wrapping Excessive size wrappers may cause drying problems User s Manual Page 51 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG eoo D So E W Figure 8 2 Double wrapping Envelope fold 8 1 5 Loading the cart e n loads which combine fabrics and hard goods instruments utensils place fabric packs on the upper shelves refer to Figure 8 3 e Place fabric packs on edge to promote passage of steam through the pack e Do not overload shelves e Do not compress packages e Provide at least 2 inches between the chamber walls and the packages the load should be within the cart e Place packages on sterilizer shelves do not staple packages e Never place utensil sets or packages outside of the cart e g chamber floor User s Manual Page 52 of 99 Revision 11 June 2008 User s
29. ct to e toii oben 69 Figure 9 iere eege 74 Figure 9 20 Cycle intervention display ssec cub ye A Ce D M A ID E T E DE 74 Figure 9 21 manual batch data ii A eee eet 15 Figure 9 22 Scanner based bateo daa ase ed tu Mb ab DU dp D o Ud eet 76 Figure 9 23 Automatic program selection by ICS 96 76 Figure 9 24 Out of cycle display with maintenance message 77 Figure 9 2 Maintenance message attests EA DN aede 77 Figure 9 26 Menu NS IN uS ae ee se sc A A A ue Saat asa ee 78 Figure 9 27 Maintenance menu display A A A ete 78 Figure 9 28 Replace doorseal dish aye a ana 79 Figure 9 29 Machine set up display e i Ae he de ad uet 80 Figure 0 302 Machine SU display a A A A a A r 81 Ad AAA A Edu Nat 81 Figure 9 32 Machine set up display E EE 82 User s Manual Page 97 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Figure 9 33 MI e o o 82 Figure 9 34 Machine set up IO A Shee a it tends 83 EC Machine SUE xc cocto c e m tete Dat tte somete eec ua 84 Figure 9 36 Machine setup 165 8535 LGR AP css e ate dE 84 Figure 9 37 Maintenance interval o de exea d epe 85 Fig re 9 38 Printer Sel LOS a A AAA atenta to a ened 86 Figure 9 39 Modify cycle parameters displasia 87 Figure 9 40 Modify cycle parameters display 2 87 Figure 91418 Copy programdispldy aae aoc ater qne adno nett se du vip d 88 Figure SC HEES 89 A EE 90 Kier He Al Detector adjustment A anra Re ace 91 Figure 11 1 Remowve printer COVBr iio 93 Figure
30. d cycle This function only works if the alarm has already gone 9 8 Batch data 9 8 1 Manual data entry Batch data entry must be activated in the set up menu Press menu button and then batch data button refer to Figure 9 19 The following batch data can be entered refer to Figure 9 21 Load details alphanumeric 12 characters batch No 12 digits Batch data is printed on the cycle documentation printer Load 1234 Figure 9 21 manual batch data entry 9 8 2 Batch data entry with Documentation system ICS 8535 BC An optional PC based cycle documentation system ICS 8535 BC can be supplied for electronic batch data acquisition Before loading the sterilizer the load ID numbers are to be read with a barcode scanner The ID s are displayed on the display refer to Figure 9 22 The bar code type EAN13 is used whereby 12 characters are displayed The 13 character is the check sum an is not displayed If necessary the last or all entries can be deleted User s Manual Page 75 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG ee transfer delete delete E batch data batch data last entry Figure 9 22 Scanner based batch data entry At cycle start the data is transferred to the system ICS 8535 and the table on the sterilizer is deleted afterwards The data can also be transferred several times to system ICS 8535 with the transfer batch data button even before progra
31. ds or any liquids at all e BURN HAZARD A steam supply malfunction may cause the sterilizer chamber to fill with scalding water Do not open chamber door if the unit fails to complete an automatic cycle or if water leaks past the door gasket upon unlocking the door e STERILITY ASSURANCE HAZARD Load sterility may be compromised if the chemical or biological indicator or the Bowie Dick Test or DART indicate a potential problem If these indicators show a potential problem refer the situation to a qualified maintenance technician before using the sterilizer further User s Manual Page 7 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG e STERILITY ASSURANCE HAZARD According to EN285 a measured leak rate greater 1 3mbar minute indicates a problem with the sterilizer Refer the situation to a qualified maintenance technician before using the sterilizer further e Before entering the chamber e g for cleaning turn the key switch off position 0 and keep the key in your pocket as long as you work in the chamber e When closing the door no person is to be inside the chamber The operator is responsible for the observation of this safety precaution User s Manual Page 8 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG CAUTIONS CAUTION Avoid letting moisture get into chamber insulation as it will cause rusting of the outer jacket CAUTION Never use sharp tools
32. e E E E pom Table 9 2 Alarm list User s Manual Page 73 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 7 Cycle intervention The cyde intervention touch screen button is used to e Abort a cycle before it is finished normally by operator access level 1 e Advance the cycle into the next phase for maintenance and qualification access level 2 or e Continue an interrupted cycle by emergency stop or motor starter failure access level 1 Press menu button The menu functions are displayed refer to Figure 9 19 readings 3 print last cycle cycle user ad maintenance Figure 9 19 Menu display Press cycle intervention button refer to Figure 9 20 cycle B cycle continue i advance Figure 9 20 Cycle intervention display 9 7 1 Cycle advance Press cycle advance button to advance the cycle into the next phase An alarm message manual advance is generated User s Manual Page 74 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 7 2 Cycle abort Press cycle abort button This causes the sterilizer chamber to depressurise if pressurised evacuate the chamber to dry and to air break The door opening deactivates the control prompts the operator to acknowledge the cycle aborted message and to Log on 9 7 3 Cycle continue Press cycle continue to continue an interrupte
33. e tests following exposure in a Bowie Dick Test cycle the pack is opened the indicator examined and conclusions are drawn as to the pattern of residual air if any that remained in the pack during the sterilization cycle Any indication of a malfunction must be reported to the supervisor who will take appropriate action to determine the cause of the problem Sterilizer should not be used during this time User s Manual Page 92 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 11 Routine Maintenance CAUTION Use only original BELIMED replacement parts for maintenance purposes in all other cases the manufacturer can no more guaranty the specified performances of the equipment nor apply the warranty conditions 11 1 Replacement of ribbon or paper roll The printer is built in a strong plastic housing with removable cover For replacing the ribbon or the paper roll the cover must be removed from the housing Step 1 Remove the cover Shift the cover while placing the two thumbs on the grooved rail and pressing into the opposite direction Figure 11 1 Figure 11 1 Remove printer cover Step 2 replace the ribbon cassette For replacing the printing ribbon press onto the edge of the ribbon cassette where the words PUSH and EJECT appear Figure 11 2 After that the ribbon cassette is unlocked on the right hand side and it can be removed Tighten the ribbon of the new cassette by tur
34. eam generator felt below minimu LI Max pressure steam generator Option Internal steam CD o Max steam pressure in steam generator exceeded o ola 5 5 E o o GE un CD o WEI supply Option Internal steam The WEI supply pressure is low lt 1bar g D 5 o Heating contactor Option Internal steam o 5 A steam generator heating contactor didn t switch off un Atmospheric pressure monitoring Atmospheric pressure switch difference to sensor P1 Deviation from time base un The real time clock deviates from the PLC time base Lack of cooling water Low cooling water pressure or cooling water tank empty 93 Overtemperature T4 Temperature in condenser is gt 80 C 62 Lack of compressed air mum HEN ESO O E O BS E pt pr p HEN EA Feed pump monitoring time has exceeded CY E proe EA p p RW EA HEN RES O O mm EE ES Compressed air pressure is lt 4 bar g User s Manual Page 72 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Time overrun TB 1 EN Loading device didn t reach end position within time limit Time overrun TB2 No st line Alarm message text Critical 2 line Cause alarm BM The PLC doesn t receive telegrams form printer interface No connection to system ICS 8535 s The PLC doesn t receive telegrams form documentation system ICS 8535 Lr m E ED nesana deve dirti im
35. ed Sauter AG 8 3 Sterility maintenance 8 3 1 Cooling All items removed from the sterilizer should remain on transfer carriage until adequately cooled e They should not be touched within cooling process e A cooling time of 30 90 minutes is recommended e During cooling the loading cart should be placed in a low traffic area where there are no air conditioning or other cold air vents in close proximity 8 3 2 Inspection As items are removed from loading cart they should be visually inspected Do not use e Any items with torn packaging e Packaging that appears to be wet 8 3 3 Sterile storage Sterile materials should be stored e at least 8 10 Inches above floor e at least 18 inches below ceiling e at least 2 inches from outside walls Items should positioned so that packaging e is not crushed e is not bent e is not compressed e can t become wet Closed or covered cabinets are recommended for the storage of seldom used supplies 8 3 4 Expiration dating Each item should be labelled with a control date for stock rotation and the following statement Contents sterile unless package is open or damaged Please check before using If the product contains material that degrades over time the product package should be labelled with a Clearly identifiable expiration date that takes this degradation into account and or that is based on the device manufacturer s instructions User s Manual Page 56 of 99 Revision 11 Ju
36. ed water quality It has to fulfil the requirements of EN285 Condition Nominal conditions Maximum conditions Temperature 4 16 C 40 60 F 21 C 70 F Degree of acidity PH 6 8 5 5 5 9 5 Calcium and magnesium 200 mg l 300 mg l Total hardness as CaCO 0 2 1 8 mmol l 2 mmol l Residue on evaporation 500 mg l 1500 mg l Conductivity at 20 C 1000 uS cm 1500 uS cm 3 3 4 9 Demonized water quality for steam generator Table 3 3 Recommended feed water quality for sterilizers Feed water has to fulfill the requirements of EN285 Annex B Table B1 The conductivity at 20 C must be 210 S cm and lt 15uS cm User s Manual User s manual MST V CB V29 doc Page 15 of 99 Revision 11 June 2008 3 3 4 10 Wiring Terminals Wiring between junction box contains main power switch and building service lines are not furnished by Belimed Connect the main supply line on the terminals as shown in Figure 3 2 Wire no Box connector no Phase L1 to 1 Phase L2 to 3 Phase L3 to 5 Neutral to N Protective Conductor to CD O ip Figure 3 2 Junction box 3 3 5 Preparation 3 3 5 1 Standard sterilizers e Check the sterilizer placement according to installation drawing e Measure overall height on the wall opening e Mark the centre lines of the sterilizer chamber on the floor with a colour marker e For correct positioning refer to installation drawing e Check the pos
37. elimed Sauter AG harmless from any and all liability for such consequential and incidental damages The responsibility of Belimed Sauter AG for damages du to injuries or death or death of employees of the Buyer or ultimate user of the Product caused by the product shall be limited to that portion of such damages as might be attributable to the negligence or strict liability of the Belimed Sauter AG Company The Buyer and ultimate user agree to indemnify Belimed Sauter AG and hold Belimed Sauter AG for harmless for any further damages indemnity or contribution If Buyer transfers title to or leases the Products sold to any third party buyer shall obtain from such third party a provision affording Belimed Sauter AG and its suppliers the protection of this article relating to Limitations of Liability and Indemnities The Belimed Sauter AG s liability for any claim of any kind including negligence and strict liability for any loss or damage arising out of or resulting from this agreement or from the performance of breach thereof or from the Products or Services furnished hereunder shall in no case exceed the price of the specified Product system component or service which gives rise to the claim Except as to title any such liability shall terminate one year from the date of installation of any Product or upon the expiration of the warranty period applicable to each type of product covered hereby whichever time period expires first IMPORTANT A S
38. er Password and Level The user name may contain maximum 20 characters and the Password may contain maximum 10 characters User names and Passwords may never be the same 9 1 3 2 Delete User Fields User and Password must be deleted in order to delete a user from the list Button BSP can be used for this 9 1 3 3 Change Password The Password can be changed easily in field Password User s Manual Page 61 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 2 Info Each user can open the information display Press menu button The menu functions are displayed refer to Figure 9 4 print Figure 9 4 Menu display Press info button The display shows the following information refer to Figure 9 5 e actual time and date e User name e Time since cycle start e Remaining time in the actual phase e Date of last Leak Test and last Bowie Dick Test e Cycle counter e Status of doors and steam generator if configured Figure 9 5 Info display User s Manual Page 62 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 3 Readings Each user can open the Readings display Press menu button The menu functions are displayed refer to Figure 9 6 e set u nll alarms last cycle cycle user ad Figure 9 6 Menu display Press readings button The display shows the actual readings of all temperature and pressure sensors used
39. erilizer User s Manual Page 32 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 6 4 Selecta cycle 6 4 1 Factory set cycles and cycle values The predefined programs of the Belimed MST V TOP 5000 steam steriliser are described in Chapter 7 1 6 4 2 Selecta cycle Ensure that the load is suitable for the intended sterilization temperature temperature resistant before selecting a cycle Five cycle selection buttons P1 P5 are shown on the screen refer to Figure 6 8 These buttons display the cycle number the cycle name and the sterilization exposure temperature 2 Fabric packs 134 C 3 4 Rubber 1219C Warm up amp Leak Test E A Bowie Dick Test close door Figure 6 8 Cycle selection buttons with cycle start button 6 5 Start a cycle The green Start button Figure 6 8 lights when the sterilizer is at start standby The selected program is started after you press the Start button if e a cycle is selected e chamber doors are closed e no alarms are pending e the minimum steam pressure is exceeded open door Figure 6 9 Cycle selection with dialog box User s Manual Page 33 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG If the sterilizer is not at start standby the cause is displayed with a dialog box Figure 6 9 when you press the Start button 6 6 In cycle During a cycle the following information is displayed
40. ge 96 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Figure 7 6 Cycle Graph Warm up La e e 43 Figure 7 7 Cycle Graph 134 C Bowie Dick Test oude 44 Figure 7 8 Cyel Graph Leak Ti SA Oe AA bath neh ones 45 Figure 7 9 Cycle Graph 134 C Heavy Instruments Cycle wenn core br ette emus 46 Figure 7 10 Cycle Graph 125 C Porous Load A ee od 47 Figure 7 11 Cycle Graph 12 1G Gravity Cy ii A i 48 Fig re 8 1 Do ble wrapping Ns a 50 Figure 8 2 Double wrapping Envelope Ich 52 Figure 8 3 Loading cart with combined solid di ia etin ed tetra 53 Figure 9e Ts Passwort ent ees aM rode LM ec LOI o EMO Ee LM LEM 59 ao MNA ene ege m une ie Re ee RU TES ERU ILC A RO EI 60 Figure 9 3 User AIN deo d ett A Re ee AAAA 60 Figure 9 4 TE A cea a eu a a cea aoa aan ae 62 Bite A O EOE TELM Eom ene 62 Figure 9 6 Ment display ae the eet SS E ada A AAA 63 Aa Readings AAA ln ht aca Rt al A E 63 Figure 9 8 MA a Ic e pr oto ROE Be DE OC 64 Aa EE usce eese eege Ee ee eege 64 Figure 9 10 Early start night time shutdown a A na 65 Figure 9 11 ERAS sa Eeer 66 Figure D Language and Units sp a 67 Figure dls A A 67 A de a eer 68 Figure 9 15 Mena DOLLS TEE US A A ae Ate A AA 68 Figure 9 16 Out of cycle display with active alatis eos e Sio o ee e fe o 69 Figure 9 17 In cycle display WAS rtr sab cote tent but tdt i ae I detur inn 69 Figure O 1B Alam display acie etc ect e c ette ret ete pa
41. he health care facility to validate the cycle Reference appropriate EN285 guidelines for validating sterilization cycles to assure the proper Sterility Assurance Level SAL as well as moisture retention acceptance criteria After modifying parameters press save parameters button A new version is generated on the basis of the date if the parameters are changed Instruments save parameters Figure 9 39 Modify cycle parameters display 1 All parameters can be displayed and modified in a further mask save parameters Figure 9 40 Modify cycle parameters display 2 User s Manual Page 87 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Procedure for displaying or changing program parameters 1 Enter the parameter number in the parameter number field Belimed Service or the technician will be able to provide you with information on the corresponding number 2 The current parameter is displayed without unit in the current value field 3 In the case of modification enter the new value in the new value field 4 In the case of modification press the save parameters button H the parameters are changed a new version is generated on the basis of the date 5 The new value is displayed immediately in the current value field None of the parameter values have a unit This means e Temperatures are displayed in tenths of 1 C e Pressure is displayed in mbar absolute
42. ight time shutdown and you want to operate turn the key switch off and on again The early start and night time shutdown are turned off User s Manual Page 65 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 4 2 Set clock Usually twice a year change of winter to summertime and summer to wintertime the time has to be adjusted Press Set clock button refer to Figure 9 11 Press the date time button and enter the time and date in the format MM DD YY hh mm ss Legend MM Month 1 12 DD Day of the month 1 31 YY Year 00 99 hh hour 1 12 mm minute 0 59 ss second 0 59 xx AM or PM save date time Figure 9 11 Set clock display Press save date time button to set the new date time 9 4 3 Language and units Each operator access level 1 can select the language he wants to have displayed Press language button in the set up menu and then press the operation language select button W refer to Figure 9 12 All predefined languages are displayed Press the language you need in the display field The display changes to the selected language The administrator access level 4 has the right to change the units Temperature e Degree Celsius C e Degree Fahrenheit F Press the temp unit select button ee and choose the temperature unit Pressure e M Millibar absolute mbara e Bar gauge bar e Kilopascal absolute kPa e Pounds square inch absolute
43. ilizer TOP 5000 Heavy Instruments Cycle Figure 7 9 Cycle Graph 134 C Heavy Instruments cycle User s Manual Page 46 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 12 125 C Porous Load Cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME Porous load 125 C 20 minutes 6 minutes Fabric Packs max 7 5kg pack Table 7 9 125 C Porous Load cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 125 C Porous Load Cycle P Figure 7 10 Cycle Graph 125 C Porous Load cycle User s Manual Page 47 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 13 121 C Gravity Cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME u Gravity121 C 121 C pue single items not vacuum proof Table 7 10 121 C Gravity cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 121 C Gravity Cyde P A 1 D Figure 7 11 Cyde Graph 121 C Gravity cycle User s Manual Page 48 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 8 8 1 Techniques of sterilization Guidelines for preparing and sterilizing wrapped packs WARNING BURN HAZARD BURN HAZARD Sterilizer and rack shelves will be HOT after cycle is run Always wear protec
44. ion for steam line and main water headers to ensure adequate supply service pressure and demand flow at equipment terminals Effect of coincident draw of multiple unit installations must also be considered 3 3 4 3 Backflow preventer If local codes require a reduced pressure principle device on water supply line it shall be provided by the customer User s Manual Page 14 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 3 3 4 4 Pressure relief valves Belimed recommends piping all chamber relief valves to a vented manifold outside the equipment service area Caution Do not reduce the discharge capacity of the safety relief valve Recommended piping practices for relief valve piping can be found in Pressure equipment directive 97 23 EG 3 3 4 5 Blow down piping Blow down building steam water and compressed air supply lines before final connection to equipment 3 3 4 6 Steam and water pressure Sterilizer is equipped to operate on pressures listed in Table 3 2 and Table 3 3 If supply pressure exceeds those shown provide reducing valves Unless otherwise specified in the contract reducing valves are not furnished by Belimed 3 3 4 7 Steam quality Steam should be condensate free and 100 saturated vapour to ensure proper goods drying It has to fulfil the requirements of EN285 3 3 4 8 Water quality Water is used for vacuum pump and heat exchangers Refer to Table 3 3 for recommend
45. ition and carrying out of the floor drains A waste water and GU gully e Put the stainless steel tub on place if required e Remove transportation screws from all door counter weights e Place the chamber on the stainless steel tub e Adjust the chamber high using the adjusting screws Refer to the installation drawing e Open chamber door e Remove door locking bolts below chamber an insert the bolt 90 turned again e Adjust the chamber high with a spirit level along x and y axis by using the 4 adjustment screws on the feeds The chamber floor must be levelled to 785mm above ground e Close chamber door e Tighten the gap between steel tub and sterilizer ground frame with silicone compound e Install the 4 pressure sensors e Fill 5 litres of water into the vacuum pump circulation tank User s Manual Page 16 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 4 Labelling 4 1 Type and Model Designation The Belimed Steam Sterilizer TOP 5000 is available in the standard or in the floor flush configuration Table 4 1 hereafter resumes size and designation Each size is offered in both 1 and 2 doors configuration Model Configuration No of Chamber Chamber size Overall Dimensions Weights kg 2 sterile volume H x W x D H x W x D Transport units 3 litres mm mm 1 Operation Inspection 6 6 6 VS1 1 door 4 3
46. les ca 55 min Instruments ca 60 min Instruments ca 60 min Noise level ISO 3746 1995 65 dBA 75 dBA Table 3 3 Utilities for chamber size 6 6 12 to 6 6 18 User s Manual Page 12 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 3 2 2 Utility connection positioning The customer shall provide all supply connection lines with a built in manual stop cock All connections assemblies between the sterilizer and supply exhaust lines customer s supply are designed with flexible pressure resistant tubes made of 316L material in that way mechanical tolerances of 25 mm in any direction can be easily compensated which results in short assembly times Only exception is the steam supply lt SD gt which is realised in a rigid manner 1 EL Electric supply main switch 2 SD Steam connection models without steam generator 3 KW Tap water supply 4 DL Compressed air supply 5 VE Deionised water supply models with steam generator 6 A Drain 7 12 Gauges refer to chapter 5 2 Figure 3 1 Utility connections User s Manual Page 13 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 3 3 Installation instructions 3 3 1 Introduction The installation of the sterilizer will generally be performed by Belimed technicians They received a detailed training on all aspects of the installation running and maintenance of the Belimed Ste
47. m start 9 8 3 Batch data input via scanner with ICS 8665 Documentation System The data is not transferred automatically to system 8565 on program start The data must be transferred to system 8565 before program start with the transfer batch data button The program is then selected automatically by system 8565 This is indicated in a dialog box After this no other program may be selected Figure 9 23 Automatic program selection by ICS 8565 User s Manual Page 76 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 9 Maintenance messages After a predefined number of cycles a maintenance message is displayed in the Out of cycle display refer to Figure 9 24 2 Fabric packs 134 C i Rubber 1219C Warm up amp Leak Test 5 close door Bowie Dick Test Figure 9 24 Out of cycle display with maintenance message cycle start The maintenance message can be acknowledged by maintenance personnel access level 3 Press maintenance button in the out of cycle mask If the maintenance has been done press ACK button in the maintenance mask refer to Figure 9 25 confirm Figure 9 25 Maintenance message display User s Manual Page 77 of 99 User s manual MST V CB V29 doc Revision 11 June 2008 Belimed Sauter AG 9 10 Maintenance functions Press menu button The menu functions are displayed refer to Figure 9 26 e me print set up last cycle alarms
48. maintenance Level 4 Administrator Level 3 Maintenance personnel Level 2 Group leader Level 1 Operator Level 0 Access without password Table 9 1 User menus and rights 9 1 2 Direct login wo wo al al al al al al al wo o In the case of visible buttons for which the user has no authorisation the user is prompted directly to enter the Password The user can log in with his or her Password and then receives access authorisation LOGIN Password Figure 9 1 Password entry User s Manual Page 59 of 99 User s manual MST V_CB_V29 doc Revision 11 June 2008 Belimed Sauter AG 9 1 3 Administrate user The Administrator Level 4 has permission to create new users delete users or change Passwords Press the Menu button The Mask menu is then displayed Figure 9 2 print last cycle ze cycle user ad maintenance Figure 9 2 Menu display Press the User Administration button Figure 9 2 A list of all users with Password and Level is then displayed Only users with Level equal to or lower than the user logged in are displayed User Password Level Figure 9 3 User administration Figure 9 3 shows the factory default users with Password and Level User s Manual Page 60 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 1 3 1 Create New User A new user can be defined by making entries in fields Us
49. manual MST V_CB_V29 doc Belimed Sauter AG Basins jJ C JC E gt Wrapped instrument trays wrapped utensils A i d JV IN Ju JN IN AN y JN y AN JN JN Figure 8 3 Loading cart with combined solid load 8 1 6 Steam sterilization cycles Cycle no 1 and 2 is recommended for full load fabric packs instrument trays utensils Cycle no 3 for is recommended for rubber load TEMP TIME TIME 1 Instruments 134 C 134 C 4 minutes 25 minutes Instrument Trays Be dd de CENNE Fabric packs 134 C 134 C Fabric Packs Rubber 121 121 C Table 8 1 Recommended solid cycles Model Sterilizer Chamber Size Wrapped Fabric Packs W x H x D mm Instrument Trays 250x550x250mm up to 14 kg each up to 7 5 kg each gross weight 6 6 6 660 x 750 x 740 4 6 6 9 660 x 750 x 1040 6 6 6 12 660 x 750 x 1400 8 6 6 18 660 x 750 x 2000 12 12 Table 8 2 Recommended solid load Ensure that the load is suitable for the intended sterilization temperature temperature resistant before selecting a cycle User s Manual Page 53 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 8 1 7 Material qualification Fabrics Use only fabrics designed for steam sterilization with 134 C Life time of fabrics depend mainly on washing and ironing the fabrics Please note the manufacturers declaration Inst
50. mp during sterilize phase Jacket set pressure not reached within pre set time steam to jacket valve not open or low steam supply pressure S Steam NE E E E E ESA ES ES EN es WN E D D o 3 1 emesene Purno seria prase te deene De ES Door on the operating end hasn t reached the end position within 20 seconds User s Manual Page 71 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG No Critical alarm 1st line Alarm message text 2nd line Cause Door 2 time overrun Door on the non operating end hasn t reached the end position within 20 seconds Door 1 not closed Limit switch door closed on operating end is not actuated during a cycle LA Door 2 not closed Limit switch door closed on non operating end is not actuated during a cycle Door not unlocked Door seal didn t unlock during door unlock step A LO CO No LO Door not locked Minimum door seal pressure not reached Ext steam generator Alarm signal from external steam generator LI Feed pump Option Interna erator a 5 CD Motor protection switch feed pump has released LI Thermo limiter Option Interna erator o 5 Thermo limiter of internal steam generator has released D Di o WI feed time overrun Option Interna Feed pump monitoring time has exceeded nterna o 5 D Di o Minimum water level Opti Water level in the st
51. ms of default programs The Chapters which follow show the pressure time diagrams in the form of a general graph for the steam steriliser without the Air Detector option Changes as a result of program parameters are reserved 7 4 1 Legend further to the process sections The process sections are identified with the following abbreviations in the pressure time diagrams 1 Pre treatment venting and increase phase 2 Sterilisation plateau time 3 After treatment suction drying and venting phase 4 Test phase User s Manual Page 39 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 7 5 134 C Instrument cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME 1 Instruments 134 C 5 Min 11 2 3 Instrument in trays or containers 134 C Min max 7 8kg tray or container Table 7 2 134 C Instrument cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 134 C Instrument cycle Figure 7 3 Cycle Graph 134 C Instrument cycle User s Manual Page 40 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 6 134 C Porous Load cycles No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME 2 Fabric packs 134 C 5 minutes 6 minutes Fabric Packs 134 C max 7 5kg pack 10 Special 134 C 60 minutes 6 minutes porous load max 7 5kg pack Table 7 3 134 C P
52. n in 134 C max 7 5kg pack max 7 5kg pack LEAK TEST max Leak rate 1 3mbar Min M ee i max Leak rate 1 3mbar Min Heavy 134 C 5 Min 11 4 3 Heavy instruments in stainless steel Instruments Min containers 134 C UDE max 14kg container gross weight max 7 5kg pack 10 Special 134 C 60 Min 6 Min porous load max 7 5kg pack Special cycles selectable on demand Bowie Dick Test pack in Table 7 1 Factory set cycles 7 2 Changes to program parameters If different cycle parameters sterilize time or dry time are required it is the responsibility of the health care facility to validate the cycle Reference appropriate EN285 guidelines for validating sterilization cycles to assure the proper Sterility Assurance Level SAL as well as moisture retention acceptance criteria User s Manual Page 38 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 3 Differences in pre treatment with the Air Detector option Three fractions are set by default in the case of fractionated pre treatment FRVV The Belimed MST V steam steriliser is delivered with 8 fractions instead of 3 in the case of sterilisers with the Air Detector option The following pressure time diagrams show the differences with respect to pre treatment FRVV Figure 7 1 Pre treatment FRVV default Figure 7 2 Pre treatment FRVV with Air Detector option 7 4 Pressure time diagra
53. n the label located in the upper part inside the servicing door on the operating end MEETS MATES n mo Power supply lv A MMM conductor Hor el CEA TI A HERNNNNNNNNN Manufacturer SAUTER AG CH 8583 Sulgen Figure 4 2 Labelling Electrical Ratings User s Manual Page 18 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 4 3 Warning labels Those labels are placed close to the respective parts which represent a potential hazard e DANGER OF SCALDING Danger of scalding Switch off the machine and empty the system before maintenance Figure 4 3 Label DANGER OF SCALDING e DANGER OVERPRESSURE Danger overpressure Switch off the machine and de pressurize and empty the system before maintenance Figure 4 4 Label Danger overpressure e DANGEROUS VOLTAGE Turn off main switch before opening Figure 4 5 Label DANGEROUS VOLTAGE e DANGER OF SQUEEZE HAND Figure 4 6 Label Danger of squeeze hand while closing chamber door User s Manual Page 19 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG e BURN HAZARD Figure 4 7 Label Burn Hazard CAUTION refer to accompanying documents Figure 4 8 Label CAUTION REFER TO MANUAL User s Manual Page 20 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 5 General description of the com
54. n touch screen and then press the log off button in the menu display refer to Figure 6 13 Figure 6 13 Menu display User s Manual Page 36 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 6 11 Turn off the sterilizer After unloading the last cycle of a day turn off the sterilizer with the key switch refer to Figure 6 1 6 12 Cycle intervention The cycle intervention touch screen button is used to e Abort a cycle before it is finished normally or e Advance the cycle into the next phase for maintenance and qualification only or e Continue an interrupted cycle by emergency stop or motor starter failure Pressing Abort causes the sterilizer chamber to depressurise if pressurised evacuate the chamber to dry if possible and to air break The door opening deactivates the control prompts the operator to acknowledge the cycle aborted message refer to Figure 6 11 See mee continue aborto advance Figure 6 14 cycle intervention display User s Manual Page 37 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 7 Cycle description 7 1 Sterilizer Factory Cycles Settings Belimed steam sterilizers TOP5000 are shipped with the factory set cycles and cycle values listed in Table 7 1 No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD mme e me rr 5M Instrument in trays or containers 134 C Min max 7 8kg tray or container 6 Mi
55. ne 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 Operator device TOP 5000 9 1 User administration Each user is defined by a e user name alphanumeric max 20 characters e user access level numeric 1 4 for user rights see chapter 9 2 e Password alphanumeric max 10 characters 9 1 1 User s rights Users with four different access levels can be defined on the TOP5000 Level 1 Operator Level 2 Group Leader Level 3 Maintenance personnel Level 4 Administrator The Administrator only can define new users or delete users Additionally one user level 5 is reserved for Belimed Service and one user level 9 is reserved for the Belimed Administrator Important In some cases only buttons for which the operator has read or write access are displayed Table 9 1 shows the TOP5000 menus with the corresponding user rights User s Manual Page 57 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Start position cycle end cycle start o wp 1 o ri o o Start positon E N to A N 1 its q i A 7 3 o User s Manual User s manual MST V_CB_V29 doc Page 58 of 99 Revision 11 June 2008 Belimed Sauter AG Level 9 Belimed admin Level 5 Belimed
56. ning the small wheel on the right hand side in the arrow indicated direction Figure 11 3 Place the ribbon cassette over the paper The paper must be between the textile ribbon and the plastic rail Place the cassette in its definitive location until it engages clearly Figure 11 4 Figure 11 2 Replace ribbon cassette 1 Figure 11 3 Replace ribbon cassette 2 Figure 11 4 Replace ribbon cassette 3 User s Manual Page 93 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG Step 3 replace the paper roll Paper rolls with a diameter of 38mm 1 5 are compatible with the printer housing Remove the ribbon cassette according to step 2 Remove the spindle with the core of the empty paper roll and place it into the core of the new roll Place the roll in this way that the paper will be carried down and forwards Figure 11 5 If necessary cut off the paper end straightly Introduce the end of the paper from underneath into the corresponding slot at the printer until there is a resistance In order to get the paper in front of the textile ribbon press the paper advance button until about 5 cm come out of the printer Introduce the ribbon cassette in its location as explained in step 2 Figure 11 6 to Figure 11 8 Figure 11 5 Replace paper roll 1 Figure 11 6 Replace paper roll 2 Figure 11 7 Replace paper roll 3 Figure 11 8 Replace paper roll 4 User s Manual Page 94 of 99 Revision 11 June 2008
57. o verify the process insert the biological indicator in a test pack refer to EN 285 EN 554 EN866 3 guidelines and place pack on the lowest shelf of the cart Run test pack through a typical Pre vacuum cycle Cycle no 1 or 2 On completion forward test pack and monitor to appropriate personnel for evaluation 10 2 Testing for pre vacuum efficiency 10 2 1 Leak Test Daily run first a Warm up Leak Test or Leak Test cycle This test measures the integrity of the sealed pressure vessel and associated piping to assure air is not being admitted to the sterilizer during vacuum steps After running a Leak Test the leak rate is printed on the cycle documentation If the leak rate is out of range additionally an alarm message is printed The malfunction must be reported to the supervisor who will take appropriate action to determine the cause of the problem Sterilizer should not be used during this time The leak rate value will help define a trend over a period of time if the integrity of the system begins to deteriorate 10 2 2 Bowie Dick Test Daily run a Bowie Dick Test cycle before processing any loads This cycle should be used to test the adequacy of air removal from chamber an load so that steam can penetrate the load It is not a test for adequate exposure to heat in terms of time at temperature Tests such as Bowie Dick are designed to document the removal of residual air from a sample challenge load In case of thes
58. oc Belimed Sauter AG Figure 8 1 Double wrapping Square fold 8 1 3 Wrapped instrument sets e Inspect instruments to make sure they are functioning properly they are clean and dry e Open disassemble or unlock instruments to permit steam contact to all surfaces e Use mesh bottom tray or wire mesh or equivalent trays e Place a fully opened huck towel in the bottom of the tray This will assist drying e Place instruments on towel distributing them as much as possible Using an adequate size tray will allow optimal distribution of the instruments e Fold the towel excess over the instruments User s Manual Page 50 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG Place internal chemical indicator on instruments Ink side should not come in contact with metal surface Wrap instrument tray sequentially in two wrappers refer to Figure 8 1 Secure with sterilizer tape and identify Recommended weight of each wrapped instrument set is 5 8 kg for minimising moisture retention The maximum weight must not exceed 10kg Notes Instrument trays must be designed for effective sterilization and drying Use a towel which covers the tray with minimum excess overhang Wrapper size should be adequate for the desired method of wrapping Excessive size wrappers may cause drying problems 8 1 4 Wrapped utensils When placing utensils in a set separate each clean dry basin from the one beneath it by
59. orous load cycles The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 Porous Load Cycles 134 C P Figure 7 4 Cycle Graph 134 C Porous load cycle User s Manual Page 41 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 7 7 121 C RUBBER Cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME 3 Rubber 121 C 20 min 6 minutes Rubber Porous load 121 C max 7 5kg pack Table 7 4 121 C Rubber cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 Rubber Cycle P A Figure 7 5 Cycle Graph 121 C Rubber cycle User s Manual Page 42 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 7 8 134 C WARM UP amp LEAK TEST Cycle No CYCLE STERILIZE STERILIZE DRY RECOMMENDED LOAD TEMP TIME TIME 4 WARM UP amp 134 C 4 minutes 3 minutes EMPTY CHAMBER LEAK TEST max Leak rate 1 3mbar Min Table 7 5 134 C Warm up amp Leak Test cycle The cycle graph provides a visual representation of the Belimed Steam Sterilizer TOP 5000 Warm up amp Leak Test Cycle P Figure 7 6 Cycle Graph Warm up amp Leak Test cycle CAUTION In order to ensure the proper function of the sterilizer run a WARM UP amp LEAK TEST cycle daily User s Manual Page 43 of 99 Revision 11 June 200
60. osition before trying to operate the sterilizer The Key Switch refer to Figure 6 1 is located on the Operating End Control Panel Turn the key in the I position on open p Steam shut off valve Main power switch e Belimed Key switch gt O J closed d us y E x Tap water shut off valve Deionized water shut off valve Figure 6 1 Utility locations User s Manual Page 28 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 6 2 Logon To operate the sterilizer a user must be logged on The operator has to enter his password refer to Figure 6 3 to Figure 6 4 Note The Belimed service personnel can configure the system that a common user is automatically logged on The common user can select and start a cycle and can operate the door User System is entered in the batch log In this configuration it is not possible to trace back to the user who started the program e Fabric packs 1349C 3 4 Rupper 121 C Warm up amp Leak Test E close door Bowie Dick Test i open door cycle start Figure 6 2 Out of cycle display Then press the log on button in the menu display refer to Figure 6 3 on eo me rint set up P alarms last cycle maintenance Figure 6 3 Menu display The log on display shows
61. ote non sterile This function is reset automatically with the next batch Air Detector Function Test The function test can be activated by pressing this button for a batch A needle valve is opened in order to create a leak in the next batch during pre treatment The documentation is created with note non sterile This function is reset automatically for the next batch Vacuum On Off Halt Continue Pressing button Vacuum On Off allows the vacuum to be generated in the chamber in initial position Pressing button Halt Continue halts or continues the function respectively This function is scheduled for setting the leakage rate of the needle valve Monitoring During Exposure Phase This button allows you to set whether the temperature of the Air Detector is to be monitored or not during the exposure phase disable air detector air detector function test vacuum f stop 1 on off Continue Figure 9 44 Air Detector adjustment For Air Detector Adjustment refer maintenance manual User s Manual Page 91 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 10 Routine Monitoring 10 1 Biological monitoring As part of the operator s verification of the sterilization process biological indicators may be used to demonstrate that sterilization conditions have been met A live spore test utilising B stearothermophilus is the most reliable form of biological monitoring T
62. peste nb eee b cus plua La ul dte ll latas a dte 29 GC MET NUTS Ee 31 63 1 GEOACING UE snesen a a a a a a a a 31 Er Gelee eet 33 6 4 1 Factory set cycles and cycle values ana daa dada 33 E ge 33 EE EN 33 A EE D E D E EAEE TTN e 34 ES ENEE M RC 34 6 8 Unloading Me EE 35 6 81 Unloading sterilize dts lolo o Llao a aa 35 User s Manual Page 2 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 6 9 EENEG DEE 36 A o eege 36 GT Tiro Mel ea 37 AA EEEE E ETE E een 37 J Cycle E TC E 38 TaT Sterilizer Factory Cycles UN ade 38 7 2 Changes to program e TE 38 7 3 Differences in pre treatment with the Air Detector option 39 7 4 Pressure time diagrams of default programs aid 39 7 4 1 Legend further to the Eeer it ane 39 To 34 C nstrument A E aaeatena aa Aaa 40 qo 134 C Porous Load ena ii ade 41 LN V2 TOC RUBBER Cycle MCI 42 7 8 134 C WARM UP amp LEAK TEST O 43 1 9 7134 C BOWIE DICK TE E 44 s UR MA a Ed ND DM scu 45 7 11 134 C o e ude dey ache Heide PRI Re eee 46 112 125C Porous Lodd ell c ccc 47 AAA E E Taia 48 Techniques of sterilization anti 49 8 1 Guidelines for preparing and sterilizing wrapped pack 49 A Rec cde hc oceania HU ad shan ents 49 p 12 Wrappeg fabrie WACK s eseneniteditetib tete tune te dit tutte a te Ded utut De dtt 49 ele e eu 50 Belay E ALG IISIIS cascade d usto date diete eek hal dau taa aa aai 51 8 5 Loading TEE 52 81 6 Steam sterili
63. ponents and functions 5 1 General view Figure 5 1 shows the main components or control elements which are accessible to the user from the operating end The number of control elements of the sterilizer is reduced to the absolute minimum in order to maximise the simplicity and security of use Maintenance door Inspection glass 6 Emergency Stop Printer T Touch operating Panel o Key switch on off 7 N Chamber gt Maintenance door Figure 5 1 Control elements operating end Figure 5 2 shows the main components or control elements which are accessible to the user from the non operating end Maintenance door Operating panel g e j Chamber M E O4 Maintenance door Figure 5 2 Control elements non operating end User s Manual Page 21 of 99 User s manual MST V CB V29 doc Revision 11 June 2008 Belimed Sauter AG 5 2 Indicators and gauges The system offers two types of indicators and gauges e The process indicators are all located on the display of the operating end control panel and of the non operating end control panel see section 5 3 and 5 4 e The service indicators and gauges are all located within the service area see service and maintenance manual The pressure gauges in the service area scaled in bar gauge
64. psia e Pounds square inch gauge for pressure psig and inches of Mercury for vacuum Un Hal User s Manual Page 66 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG Press the pressure unit select button w and choose the pressure unit english Figure 9 12 Language and units display 9 4 4 Steam generator If the steam generator can be activated form the sterilizer option you can turn on and off the steam generator by pressing the steam generator button refer to Figure 9 9 9 4 5 Drain steam generator If an internal steam generator option is installed it can be emptied by pressing the drain steam generator button refer to Figure 9 9 9 4 6 Configure cycle selection The administrator level 4 can define e The selectable cycles by a user can be activated green or locked red e Cycle start only after entering a password by the operator set yes e Automatic logon with user name Sytem using level 1 set yes To activate a cycle or a function or press corresponding button refer to Figure 9 13 Figure 9 13 Configure cycle selection User s Manual Page 67 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 4 7 Display contrast All logged on users can adjust the display contrast Refer to Figure 9 14 To increase the contrast of the display press contrast button To decrease the contrast of the display pres
65. re during sterilize phase on built in printer default 60 s The software version of the panel is displayed Figure 9 34 Machine set up display 6 User s Manual Page 83 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG The seventh display refer to Figure 9 35 functions are e Define the external documentation system none 8535 8535 BC 8565 BC Barcode reader for recording the load e f an external documentation system type ICS 8535 is connected via serial interface RS485 enter the sterilizer system address communication port address range 3 20 Figure 9 35 Machine set up ICS 8535 e P address documentation system ICS 8535 with Ethernet connection if the sterilizer is connected to an ICS 8535 documentation system each unit must have a TCP IP address Click on the Set IP address button to accept this address after it has been set Figure 9 36 Machine set up ICS 8535 TCP IP User s Manual Page 84 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 10 5 Maintenance interval The factory set maintenance intervals can be changed by Belimed maintenance personnel when special circumstances require shorter intervals e g quality of utilities do not fulfil our specifications The standard settings are defined in the Maintenance Manual Refer to Figure 9 37 The current values are displayed at the right You can reset the maintenance counters at an
66. rilized Check their proper function according to the manufacturer s information of the goods e g instruments User s Manual Page 9 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 3 Installation 3 1 Sterilizer sizes The Belimed steam sterilizers are available in the following sizes Table 3 1 Model Configuration No of Chamber Chamber size Overall Dimensions Weights kg 2 sterile volume HxWxD HxWxD Transport units 3 litres mm mm 1 Operation Inspection 6 6 6 VS1 1 door 4 305 660 x 660 x 700 1970 x 980 x 960 1040 700 780 1000 6 6 6 VS2 2 doors 4 305 660 x 660 x 700 1970 x 980 x 960 1040 750 830 1050 6 6 9 VS1 1 door 6 440 660 x 660 x 1000 1970 x 980 x 1260 1340 800 910 1240 6 6 9 VS2 2 doors 6 440 660 x 660 x 1000 1970 x 980 x 1260 1340 850 960 1290 6 6 12 VS1 1 door 8 565 660 x 660 x 1300 1970 x 980 x 1560 1640 900 1040 1465 6 6 12 VS2 2 doors 8 565 660 x 660 x 1300 1970 x 980 x 1560 1640 950 1090 1515 6 6 18 VS1 1 door 12 880 660x660 x 20001 1970 x 980 x 2260 2340 1 100 1240 1865 6 6 18 VS2 2 doors 12 880 660x660 x 2000 1970 x 980 x 2260 2340 1150 1290 1915 1 without with control panel above chamber 2 Weight with internal steam generator 3 1 Sterile unit H x W x D 300x600x300mm Table 3 1 Sterilizer sizes User s
67. rilizers Those details of the installation are part of their specific know how and will not be written down here If the customer requires to perform the installation himself Belimed will provide the necessary information and at least insure the supervision of the installation This is required in order to be able to insure the warranty of the system for the accepted duration Each installation drawing pertains to the sterilizing equipment as specified or purchased by the customer The general notes and recommendations are intended to complete the installation drawings 3 3 2 Space considerations Clearance in front of sterilizer for comfortable loading and unloading operations should be about twice the length of the transfer carriage unless otherwise specified on installation drawing 3 3 3 Mounting details 3 3 3 1 Service power One convenience outlet 230V is required for power tools next to the sterilizer 3 3 4 Utility service requirements 3 3 4 1 Terminal Fittings Unless otherwise specified in the contract piping shutoff valves and other appurtenances between terminal fittings on the equipment and wall or floor outlets are not furnished by Belimed Note Supply lines are to be safeguarded and separable in accordance with connection ratings 3 3 4 2 Pipe sizes Pipe sizes listed in paragraph 3 2 indicate the equipment termination sizes only Size of supply piping is dependent on length of pipe run from pressure regulation stat
68. rocess time or the chamber temperature on side 2 will be displayed e The door opening closing function can be set to an inching mode door moves only as long as the door open or door close button is pressed 10 open door on operating end 1c close door on operating end 20 open door on non operating end 2c close door on non operating end Figure 9 32 Machine set up display 4 The fifth display refer to Figure 9 33 functions are only with internal steam generator e Blow down interval default 1800s e Blow down pulse default 2s e degassing time default 2 sec depending on water quality e to reduce peak current the second heater can be delayed e during heat up phase default 2 sec during standby phase default 20 sec User s Manual Page 82 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG The sixth display refer to Figure 9 34 functions are Start point of the reduced steam pressure increase rate below sterilize pressure default 200mbar Pressure increase rate before sterilization reduced ramp default 200mbar min to prevent an over temperature on the top of the chamber Open time steam valve gravitation the steam inlet and thus also the steam outlet can be reduced by reducing the open time in the range between 10 and 100 Maximum chamber pressure during gravity the chamber steam valve is closed when the maximum chamber pressure is exceeded Print interval and data sto
69. ruments Use only instruments designed for steam sterilization with 134 C Instrument life time depends mainly on use and cleaning with chemicals 100 ASTM 316 Stainless steel instruments can generally be used for steam sterilization For other materials note the manufacturers declaration Other materials Before sterilizing other materials e g rubber refer to the manufacturers recommendations and restrictions steam temperature max sterilization time For rubber use only 121 C Rubber cycle 8 2 Guideline for Determining wet packs 8 2 1 Introduction Aseptic techniques for surgical procedures require that all supplies coming in contact with the surgical field have to be sterile An inherent inseparable quality for sterility of supplies is a state of dryness Wet materials transmit bacteria therefore a state of wetness would compromise the sterility of process packs and instruments presented to sterile field 8 2 2 Evaluation of wet packs A load must be examined for wet packs for three conditions e Water droplets on the exterior of a pack e Water droplets within a pack e Absorbed moisture in a pack User s Manual Page 54 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 8 2 3 Moisture retention acceptance criteria The EN285 1994 sets the following acceptance criteria 8 2 3 1 Fabric packs Moisture retained by the fabric test pack must cause no more than 1 increase in
70. s contrast button early start set ae night shutd clock guag steam config cycle contrast generator selection x drain steam TB side 1 online generator automatic docu TB side 2 automatic Figure 9 14 Set up display 9 4 8 Online documentation If there is an external PC based documentation system ICS 8535 installed the built in printer can be turned off refer to Figure 9 14 In case of a breakdown of the system ICS 8535 the built in printer can be activated by the group leader Active green background 9 4 9 Automatic loading and unloading device The optional external loading TB1 or unloading device TB2 can be activated refer to Figure 9 14 With the buttons T and J the loading device can be moved manually 9 5 Print last cycle The cycle documentation is printed at the end of the cycle It is possible to print a copy of the cycle documentation until the next cycle is started Press menu button The menu functions are displayed refer to Figure 9 15 readings print alarms last cycle batch data Use ac ministration maintenance Figure 9 15 Menu print last cycle display User s Manual Page 68 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 6 Alarm messages All important process parameters are continuously monitored If there is a deviation an alarm button is displayed in the main mask refer to Figure 9 16 user ad ele bath dan Fig
71. ss and water steam consumption can only be achieved when the loading prescriptions are respected Following aspects are to be followed The goods to be sterilized must be placed on the loading racks especially designed therefore avoid placing the goods directly onto the chamber floor Each shelf of the loading rack must be loaded individually do not stack trays Containers may be stacked only if their steam openings are remain free Some container types can only be stacked for transportation but not during sterilization When wire baskets are stacked pay attention that the goods of the underlying basket shall not be compressed The package must be able to expand during the sterilization process Heavy sterilization items shall always be placed in the lower part of the unit Overfilled baskets and trays can cause problems Loading of baskets has to be achieved in such a way that a hand can easily fit between the packs without compressing them Container weight Shall be limited to 7 8 kg for Textiles and max 10 kg for Instrument load Foil paper packaging has to be stacked in an oblique way to each other the paper side located downwards Textiles have to be placed vertically whenever possible Instruments shall be equally distributed among the tray Loading has to be performed with similar instruments or goods to be processed A recommended load can be the following Porous materials and textiles together Single or small amount of instruments
72. sterverhasbemnmesed weerpeeconsshvmempmphe wes B mmm 777 E or roteton stc o door noos estes Fio ce sor has been actnated by an operator or by de sem iei O O PLC battery empty do not switch off electric power switch change buffer battery am On Off Key switch off The key switch was turned off during cycle running Too long in step itoring time of a cycle phase has been exceeded EE Sen Ho CD 3 perature sensor T1 signal e 0 150 C kal s aal o o o o 3 5 3 5 ca D 5 d sensor T is out of rang C d d e sensor T4 signal is out of range 0 C T5 signal is out of range 0 C Ho CD 3 ca D 5 E 6 Ex ES 8 p 9 C 2 The monitoring ERE ES 12 MN E ES Es be 15 ile 2s faile 3 si i E pan is C User s Manual Page 70 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG No st line Alarm message text Critical iH 2 line Cause alarm Pressure sensor Pi soral sonorae azma OOO RECETTE SS n S ailed 1 T ed Pressure sensor P4 si is out of range 4 20m Undertemperature T1 Chamber temperature T1 is below alarm set point during sterilization phase gt x lt ignal gnal A e eso al ge ti gnal A ni During sterilization phase the difference T1 T2 is gt 1 C Air detector doesn t reach set temperature or is below set te
73. strument trays with single or multiple instruments can be sterilized The Belimed Steam Sterilizer TOP 5000 is factory equipped with cycles which has been tested in accordance with EN285 standards under defined load conditions The cycles parameters can be easily modified to perform the sterilization under optimised conditions A modification of the parameters of the standard cycles is under the responsibility of the user BELIMED can offer assistance or quote complete validation procedures to the relevant standards WARNING This sterilizer is not designed to process liquids CAUTION Any alteration of the sterilizer which affects its operation will void the warranty and could violate state and local regulations and jeopardize insurance coverage CAUTION Use only original BELIMED replacement parts for maintenance purposes in all other cases the manufacturer can no more guaranty the specified performances of the equipment nor apply the warranty conditions CAUTION In order to ensure the proper function of the sterilizer run a WARM UP amp LEAK TEST cycle daily CAUTION The Bowie Dick Test Cycle has to be performed daily User s Manual Page 6 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 2 3 Summary of safety precautions The following is a summary of safety precautions to be observed when operating or servicing this unit WARNINGS indicate the potential for danger to
74. tenance manual EPT SERE i doorseal door seal gt complete Figure 9 28 Replace door seal display 9 10 2 Calibrate touch screen If the touch screen adjustment is inaccurate adjust the touch screen Press calibrate touch screen button and follow the instructions refer to Figure 9 27 9 10 3 Sensors adjustment For sensor adjustment refer maintenance manual User s Manual Page 79 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 9 10 4 Machine set up The Belimed maintenance personnel must set the machine set up before running the first cycle The first display refer to Figure 9 29 must be adjusted e Enter hospital name into the hospital name field e Enter department name into the department field e Enter the machine number serial number into the machine No field e Enter the ambient pressure in mbar absolute into the norm ambient pressure field The ambient atmospheric pressure depends on the altitude of the sterilizer Enter the following values Altitude m ambient pressure mbar Altitude m ambient pressure mbar 0 1013 1200 877 200 989 1400 856 400 966 1600 835 600 943 1800 815 800 921 2000 795 1000 898 2200 7715 Table 9 3 Ambient pressure for altitudes up to 2200m Figure 9 29 Machine set up display 1 User s Manual Page 80 of 99 Revision 11 June 2008 User s manual MS
75. the Batch data menu refer to chapter 9 8 1 If the optional documentation system ICS 8535 BC is installed enter batch data with the barcode scanner first before loading the sterilizer refer to chapter 9 8 2 e Open the chamber door by pressing the open door button e Verify that loading cart is securely fastened to the transfer carriage e Align the front end of the transfer carriage with the end of the sterilizer refer to Figure 6 6 e Move carriage forward until lever latches with lock bolt Verify that transfer carriage is latched with chamber by pulling transfer carriage backwards transfer carriage must remain stationary Unlock loading cart by pushing unlock handle and pushing the cart into the sterilizer chamber e Disengage transfer carriage e Push transfer carriage in chamber direction e Pull transfer carriage unlock lever e pull transfer carriage away from the sterilizer chamber Close the chamber door by pressing the close door button until door is closed Chamber Running rail Lock bolt Align transfer carriage parallel to chamber Positioning lever Transfer carriage Figure 6 6 Align transfer carriage with chamber User s Manual Page 31 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG Loading cart Transfer carriage bow Transfer carriage unlock handle Transfer carriage unlock lever Transfer carriage Figure 6 7 Loading st
76. tive gloves and apron when removing a processed load Protective gloves and apron should also be worn when reloading sterilizer following previous operation 8 1 8 1 1 Preparing load Before sterilization materials must be thoroughly cleaned Wrappers may be made of 100 cotton 140 thread count two ply fabric and freshly laundered Reusable wrappers should be laundered between sterilization cycles Before wrapping packaging materials must be dry and should be under room temperature 15 C 25 C and at a relative humidity ranging from 30 60 for at least 2 hours 2 Wrapped fabric packs Place two wrappers on work surface Place contents on wrappers Fabrics should be folded flat with each succeeding layer placed crosswise to the one below to promote free steam circulation Place internal chemical indicator in the centre of the pack Wrap contents sequentially in two wrappers refer to Figure 8 1 Secure with sterilizer tape and identify The maximum weight must not exceed 8 kg density factor not in excess of 0 47kg dm3 and the size must be limited to 250x500x250mm Single Fabric Test Pack for validation should weigh approximately 7 kg and the size must be limited to 220x300x250mm Notes Wrapper size should be adequate for the desired method of wrapping Excessive size wrappers may cause drying problems Do not wrap too tightly User s Manual Page 49 of 99 Revision 11 June 2008 User s manual MST V CB V29 d
77. ure 9 16 Out of cycle display with active alarm Figure 9 17 In cycle display with active alarm Press alarm button All active alarms are displayed refer to Figure 9 18 The alarm mask has 3 buttons e Help e ACK e history The alarm is displayed with number time date and the alarm message Each alarm must be acknowledged by an operator access level 1 e To acknowledge an alarm press the ACK button e To display the history of the last 250 alarms press history button e To get more information about the active alarm press Help button 1 Emergenc Figure 9 18 Alarm display User s Manual Page 69 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG The operator should follow the Help instructions on the alarm Display If these instructions fail to clear the alarm consult your department supervisor or a trained service technician before using the sterilizer further 9 6 1 Critical alarms Only the critical alarms are printed out in the batch report If a critical alarm has occurred during a cycle the door can only be released on the operating end A message cycle failed is displayed on the operating panel and printed on the batch documentation The start of a new cycle is not possible if a critical alarm is pending 9 6 2 Alarm list Table 9 2 shows the list of alarms and the possible causes No st line Alarm message text Critical IW CE eiersenStopbuton onthe
78. vacuum pump A Floor drain waste water open ER max 15 ER max 20 l min l min GU Floor drain 2 7 AL1 Air outflow from service room 1 5 kW 1 8 kW heat flow of 1 kW to be dissipated temperature in service room 30 C Option waste steam line upwards AD1 Waste steam chamber max 2 7 1 nipple 240 kg h max 2 7 1 nipple 240 kg h AD2 Waste steam jacket max 2 7 1 nipple 240kg h max 2 7 1 nipple 240kg h AD3 Waste steam steam generator max 3 5 1 nipple 290 kg h max 3 5 1 nipple 290 kg h Option Cooling water circuit KWV Cooling water forward 2 5 Y 2 mih 2 5 Y 2m h o 4001 500 Bh 26000kJ 32000kJ Cooling energy required 8kW 10kW KWR Cooling water backward Y Y Table 3 2 Utilities for chamber size 6 6 6 to 6 6 9 User s Manual Page 11 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG Model 6 6 12 VS1 6 6 12 VS2 6 6 18 VS1 6 6 18 VS2 d ES s 2 8 8 o gt o s amp 2g SZ 2 2 5 c SN E c A 2 E Ki E E tel ei E alg S sge 5 ES ES A g x 2 a 2 x a SA ES S E a 59 S f 3 52 a E o a os a o a os Standard Supply lines SD Sterilizing Steam 2 5 3 Y 70kg h 19kg 2 5 3 Y 100 kg h 25 kg KW Tap water for vacuum pump 15 C 2 5 y 1 2 m h 3801 Jub y 1 2 m3h 430
79. y time by pressing the reset buttons Figure 9 37 Maintenance interval display User s Manual Page 85 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 10 6 Printer self test The printer system test forces a printout refer to Figure 9 38 Thereby the following are tested Serial communication between PLC and Printer interface Serial communication between Printer interface and printer Printer interface Accuracy of Sensor inputs on printer interface T2 P2 if a reference RTD T2 134 C and a reference input current P2 12mA are connected to the sensor inputs Printer function A record is printed out with machine type and no date time set values actual values allowed tolerance and result Additionally to the system test a printout of the alarm texts and the cycle phase texts can be forced al Alarm texts print self test l Figure 9 38 Printer self test User s Manual Page 86 of 99 Revision 11 June 2008 User s manual MST V CB V29 doc Belimed Sauter AG 9 10 7 Modify Cycle Parameters and copy program The Belimed maintenance personnel can modify the following cycle parameters refer to Figure 9 39 e Cycle name e Sterilize time e Dry time IMPORTANT The cycles listed in Table 7 1 have been validated using the techniques documented in EN285 If different cycle parameters sterilize time or dry time are required it is the responsibility of t
80. zation Cycles riris E E a 53 E ANE NERT 211 EE 54 8 2 Guideline for Determining wet Packs scroll doc 54 So Mt 54 E A ta Ea fats 54 8 2 3 Moisture retention acceptance criteria rr vage pota guid ov t 55 8 2 4 Solving T meia MO TENENTE 55 9 3 Sterility maintenan E oem esae cn iod ioni cn Mea MAS Rene ean eh alas d ea dee a iere 56 A e riako eea eO A a DAA ETET dap EA S 56 213325 KoE LOM Da OE ODD DO DR DEO bM 56 NET 56 8 321 EIDEN 56 9 Operator device TOP 5000 iris e 57 SCH Usera i 57 Oriel USES Mer eegene 57 On Direct a EE mats nt 59 9 1 3 Administrate User tinn a a a E n 60 SM ER 62 Een 63 User s Manual Page 3 of 99 Revision 11 June 2008 User s manual MST V_CB_V29 doc Belimed Sauter AG 94 DUDAS 64 9 4 1 Early start night time shutdown noia 65 SE EE Eden EE 66 SAS kanguage and UNITO ioina ve tete etu EE edat ue ue metano 66 944 ee 67 O A teen ee odo todo dotada o nd 67 SLEG Configure ENEE egene Eeer 67 947 DIM ent 68 9 4 8 Online EES 68 9 4 9 Automatic loading and unloading device o ccoconococicnonocncenenenononcnrornrcrcenennonrnrnross 68 A E ETE m 68 E E 69 961 Critical al MNS AAA 70 o a a ain 70 O 74 E eer 74 A A ee en ere ee eee eee ere ee ne 75 EE el 75 SE EE EE 75 98T Manta nt 75 9 8 2 Batch data entry with Documentation system ICS 8535 BC cece 75 9 8 3 Batch data input via scanner with ICS 8665 Documentation System 76 Sua Manten messages rta FORD REA 71 9 10 Maintenance THETGDORS

User's manual MST-V_CB_V29 - Frank's Hospital Workshop

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