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Thermo Scientific VARIOKLAV 65 TC Operating Manual

Steam sterilizer
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VARIOKLAV
Steam sterilizer 65 TC
Operating manual
50112712_082007_GB

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Summary of Contents for Thermo Scientific VARIOKLAV 65 TC

  • Page 1 VARIOKLAV Steam sterilizer 65 TC Operating manual 50112712_082007_GB...
  • Page 2 +49 6184 90 69 40 Phone: +49 89 54 84 28 81 Fax: +49 6184 90 74 74 Emergency - Phone:49 173 9 72 77 43 Fax: +49 89 54 84 28 89 Internet: www.thermo.com Internet: www.hille-technik.com Email: info.labequipment.de@thermo.com Email: hille@hille-technik.com Thermo Scientific 50112712_082007_GB...

  • Page 3: Table Of Contents

    Preparing the sterilization load ............. 51 8.3.1 Packaging types pursuant to DIN EN 868-1 (05-97) ....51 8.3.2 Steel wire baskets................. 52 8.3.3 Sterilization containers..............53 8.3.4 Loading the sterilizing chamber ............ 54 Selecting sterilizing programs ..............57 Thermo Scientific 50112712_082007_GB...
  • Page 4 Preparations for transport (frost protection) .......... 78 15.1 Recommissioning................80 Packing the sterilizer ................. 81 Opening the door without power.............. 82 Technical specifications, abridged ............83 18.1 Recommended feed water quality according to DIN EN 285:2006 .. 83 Glossary ...................... 84 Thermo Scientific 50112712_082007_GB...

  • Page 5: User Considerations

    (instruments, bowls). For sterilizing and drying porous materials, textiles, or tubes where it is indicated that these are suitable for steam sterilization. Implants certified for steam sterilization by the manufacturer and possessing no lumens or fillings. Thermo Scientific 50112712_082007_GB...
  • Page 6 • Deciding on the release of non-approved sterile packs. • Evaluation of operating situations and process where performance values lie outside the prescribed limits or threshold limit values and necessary measures where required. Conventions Indicates a list. ♦ Indicates an operating step. Indicates alternatives. Thermo Scientific 50112712_082007_GB...

  • Page 7: Safety Considerations

    Information concerning an easier working practice will appear at the appropriate places in the text. LIFE HAZARD No matter what the problem, never use force when opening or closing the swing door of the sterilizer. Life hazard! The system might be damaged! Thermo Scientific 50112712_082007_GB...
  • Page 8 Step back when opening the sterilizer. DANGER You must wear heat-isolating protective gloves and long- sleeved working clothes when opening and loading the sterilizing chamber (9) and when removing the sterilized articles: Watch for hot surfaces and hot steam! Thermo Scientific 50112712_082007_GB...
  • Page 9 This allows you to check sterilizing conditions and sterilization quality on a daily basis. DANGER To ensure uniform testing conditions, it is recommended to perform the Bowie & Dick test when the sterilizer is hot. To insure this, execute the Vacuum & Empty program first. Thermo Scientific 50112712_082007_GB...
  • Page 10 (where appropriate) the bottom is to be checked. This will guarantee safe storage conditions. Replace the filter if necessary. DANGER Check the sterilized items for apparent damage. Damaged and / or moist packaged items must be considered non-sterile. Thermo Scientific 50112712_082007_GB...
  • Page 11 Only connect the sterilizer to the specified socket. DANGER When a fault occurs and for maintenance purposes, disconnect the steam sterilizer from the mains supply. Pull the mains plug or neutralize the fuse. See type plate. Thermo Scientific 50112712_082007_GB...
  • Page 12 Only use deionized or distilled water when topping up feed water. Do not use tap water! Feed water quality pursuant to DIN EN 285. CAUTION For error-free operation and to avoid corrosion damage, carefully follow the maintenance manual. Thermo Scientific 50112712_082007_GB...

  • Page 13: In Case Of Emergency

    A mains circuit breaker with an ELCB switch and the CEE socket must be installed in the immediate vicinity of the unit. The sterilizer is disconnected from mains. ♦ In emergencies contact the authorized Thermo service: +49 / 173 / 97 27 74 3 Thermo Scientific 50112712_082007_GB...

  • Page 14: Termination Program

    ♦ Select the correct sterilizing program for your load. ♦ Start the newly selected sterilizing program. In case of anomalies and problems: ♦ Contact the authorized service: DANGER If a program is interrupted, the load must be re-sterilized for safety reasons. Thermo Scientific 50112712_082007_GB...

  • Page 15: Residual Sterilizing Risks

    • Damaged and / or moist packaged items must be considered non- sterile. • If the sterilizer is deployed in a different place, environment conditions may change. E.g. deviant process-relevant parameters as per DIN EN 285 Thermo Scientific 50112712_082007_GB...

  • Page 16: Unpacking The Sterilizer

    3 Unpacking the sterilizer 3 Unpacking the sterilizer VIII VIII B In order to commission the VARIOKLAV Type 65 TC steam sterilizer, please follow the Initial Commissioning Instructions to the letter. Thermo Scientific 50112712_082007_GB...

  • Page 17: Putting The Sterilizer Into Service

    INFORMATION The temperature of the cooling water influences the suction power of the water ring vacuum pump: The colder the cooling water, the higher the vacuum attained. Recommended values as per DIN EN 285 (1997), Annex B. Thermo Scientific 50112712_082007_GB...
  • Page 18 The term "machinery" also covers an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole. (3) The following are excluded from the scope of this Directive: steam boilers, tanks, and pressure vessels. Thermo Scientific 50112712_082007_GB...
  • Page 19 Technical specifications including functional description and flow diagram (FI diagram); Electrical circuit diagrams with legends; List of spare parts. Calibration logs of the temperature sensor and the pressure sensors respectively Thermo Scientific 50112712_082007_GB...

  • Page 20: Tests

    Validation of sterilization processes pursuant to Section 4, paragraph 2 of the German Regulation for Operators of Medical Devices (MPBetriebV) has to be applied for by the owner and can only be performed by the operator. Suitable validating aids are available from Thermo Electron on request. Thermo Scientific 50112712_082007_GB...

  • Page 21: Scope Of Delivery

    Hoses for supply and waste removal are supplies as per the accessories ordered. Warranty periods 1-year warranty for all electrical and mechanical parts. Exception: expendable items. 5 years warranty for stainless steel pressure vessel and double wall. Thermo Scientific 50112712_082007_GB...

  • Page 22: Installation

    For further details, please consult the Initial Commissioning Instructions. Lateral view 65 TC Front view 65 TC Vorderansicht 65 TC 850 mm 569 mm 530 mm Bottom view 122 mm 613 mm 50 mm Figure 1: Footprint, VARIOKLAV Type 65 TC benchtop sterilizer Thermo Scientific 50112712_082007_GB...

  • Page 23: Installation Site

    Section 1 which comply with this Directive and bear the CE marking indicating that they have undergone conformity assessment in accordance with Section 10. The weight when performing on-site water pressure tests for pressure vessels or steam boilers for repeat testing is also 250 kg. Thermo Scientific 50112712_082007_GB...

  • Page 24: Heat Emanation

    Actions to be taken on malfunctions such as power failure, absence of other consumables such as steam, cooling water, aeration, or fire and actuating safety valves; Turning off the unit; k) Unit care; Residual risks during correct use; m) Consequences of operator error. Thermo Scientific 50112712_082007_GB...

  • Page 25: Instructions For Maintenance

    Inspections; g) Maintenance tasks; h) Repairs; Modifications to the sterilizer or to the consumables supply; Recommissioning; k) Repeated performance evaluation; Repeat testing of the pressure device and related equipment; m) Extraordinary operation modes. Thermo Scientific 50112712_082007_GB...

  • Page 26: Controlling The Batch

    DIN EN 285. If the sterilization values are within the predefined range, the process evaluation system accepts and releases the sterilization process. The printout on the printer (3) will read Program cycle successful. Thermo Scientific 50112712_082007_GB...

  • Page 27: Short Operating Manual

    5 Short operating manual 5 Short operating manual INFORMATION Attach the short operating manual close to the sterilizer. Thermo Scientific 50112712_082007_GB...

  • Page 28: Equipment Description

    6 Equipment description 6 Equipment description Components Figure 2: VARIOKLAV 65 TC Case and control panel Thermo Scientific 50112712_082007_GB...
  • Page 29 6 Equipment description Figure 3: VARIOKLAV 65 TC control panel, detail Figure 4: Integrated printer control panel, detail Door : Closes the sterilizing chamber. Locking lever (inside the : Lock the door. Two locking levers keep the inner door moulding) closed door tightly locked to the housing anchors.
  • Page 30 21 Door indicator : Indicates the condition of the door: yellow door closed, locked. green door open, unlocked. While the door is being locked or unlocked by the locking levers, both indicator lights are off. Thermo Scientific 50112712_082007_GB...
  • Page 31 The integrated timer (24) is used to set a start time for the sterilization cycle on the control panel (6) (see Chapter 10.3). During the entire period of operation, the sterilizer can be kept at working temperature using the Preheating key (23). This improves sterilization quality and reduces the risk of infection. Thermo Scientific 50112712_082007_GB...
  • Page 32 Filter block with filter cartridge Feed water tank Double wall Door T1/2 Sterilizing Monitoring Monitoring / control Heating chamber Double wall Sterilizing chamber temperature temperature Figure 5: Schematic representation of the VARIOKLAV Type 65 TC with double wall Thermo Scientific 50112712_082007_GB...

  • Page 33: Function

    Preheating key (23). For the definitions of primary pack and transport pack: see Chapter 8.3.1. „Speicherprogrammierbare Steuerung“: Control can be programmed via memory. Required values as per DIN EN 285 (1997), Annex B. Thermo Scientific 50112712_082007_GB...

  • Page 34: Safety Features

    The enclosed diagram gives you an overview over structural and programmed safety features (see annex). Thermo Scientific 50112712_082007_GB...

  • Page 35: Preparing For Sterilization

    CAUTION Take care to ensure that the door seal (7) is: free from dirt, not sticking to the door (1), and not damaged. The door seal (7) must sit snugly in the groove. Thermo Scientific 50112712_082007_GB...

  • Page 36: Requirements For Operation

    (see Maintenance Manual) • Documented instruction of users for daily operation and maintenance (see Chapter 4.6). • Operating instructions are available. • Type approval is available. • Validation was performed. Thermo Scientific 50112712_082007_GB...

  • Page 37: Preparing The Sterilizing Chamber

    Maximum level: see Figure 7. ♦ If necessary, fill the feed water tank (5) with completely deionized or distilled water. Max. Min. Screen Figure 7: Feed water tank filling level (5) Required values as per DIN EN 285 (1997), Annex B. Thermo Scientific 50112712_082007_GB...

  • Page 38: Sterilizing Programs

    (6) (see Figure 8) come with specific program runs assigned to them. This means that in addition to the process itself, the sterilizing time and temperature and certain options for a sterilizing article are predefined. Cycle Figure 8: Program keys on the control panel Thermo Scientific 50112712_082007_GB...
  • Page 39 Sterilizing program for packaged or unpackaged porous loads. After the sterilization cycle, the sterilized laundry contains < 1 % residual moisture. Pursuant to EN 868-1, packaged goods may be present in a primary pack or a transport pack (for a definition see Chapter 6.3.1). Thermo Scientific 50112712_082007_GB...
  • Page 40 Remove lidseal: This service program is restricted to service mode. “Ordinary” can see it in the cycle display (18) but cannot exe- cute it. The following diagrams describe various sterilization cycles. Thermo Scientific 50112712_082007_GB...
  • Page 41 When 20 kPa are reached, the drying phase starts. Throughout the drying phase, the double wall is maintained at sterilizing temperature. The sterilizing chamber is aerated via the sterile air filter. Thermo Scientific 50112712_082007_GB...
  • Page 42 = Beginning of the equilibration phase = Beginning of the testing phase = End of the testing phase Pressure Time (min) 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Diagram 3: Vacuum test Thermo Scientific 50112712_082007_GB...

  • Page 43: Sterilization Control

    All process data are documented in a tamper-proof fashion by the integrated printer (3) (see Chapter 9.1). In this way, all relevant information for each test run or sterilization process is reliably stored for future reference. Thermo Scientific 50112712_082007_GB...
  • Page 44 ♦ Close the door (1) until it touches the sterilizing chamber (9). ♦ Press the START/STOP key (20). The door is automatically locked. The yellow control LED on the control panel (door indicator, 21) is lit. The Vacuum test program is started. Thermo Scientific 50112712_082007_GB...
  • Page 45 The test pack consists of special DIN A5 paper that can be reused 15 times (see Figure 11). For details, see the detailed user instructions by the manufacturer enclosed with the test pack. Thermo Scientific 50112712_082007_GB...
  • Page 46 If necessary, you may arrange the sheets. ♦ Place an indicator test sheet in the middle of the test pack and load the test pack into the frame. Thermo Scientific 50112712_082007_GB...
  • Page 47 ♦ Place the STERICLIN Bowie & Dick simulation test pack in a steel wire basket in the lower third of the sterilizing chamber near the door. ♦ Place the helix test pack (test object with indicator system) on a steel wire basket near the bottom. Thermo Scientific 50112712_082007_GB...
  • Page 48 (9) and removing the sterilized articles: Watch for hot surfaces and hot steam! ♦ Remove the STERICLIN Bowie & Dick simulation test pack from the sterilizing chamber (9). ♦ Remove the test object with indicator system. Thermo Scientific 50112712_082007_GB...
  • Page 49 If the indicator strip of the test object with indicator system (helix test) does not reveal four uniformly blackened bars, optimal sterilizing conditions are not ensured. In this case, please contact a service agency without delay and stop using the sterilizer. Thermo Scientific 50112712_082007_GB...

  • Page 50: Daily Release Of The Sterilizer

    If the sterilizer is not used immediately on being cleared for use: INFORMATION It is recommended to keep the sterilizer at working temperature until the sterilization workload has been completed. Always press the Preheating key after unloading sterilized items. Thermo Scientific 50112712_082007_GB...

  • Page 51: Preparing The Sterilization Load

    Pack containing one or several medical devices in their primary packs. Example: Transparent pack inside a pack Transport pack: Pack containing one or several primary and / or secondary packs, designed to offer adequate protection during transport and storage Thermo Scientific 50112712_082007_GB...

  • Page 52: Steel Wire Baskets

    This allows the steam to circulate freely and the condensate drips off ideally. Primary pack: The sealed or closed package system enclosing the medical device in an impermeable manner. Thermo Scientific 50112712_082007_GB...

  • Page 53: Sterilization Containers

    Perforated stainless steel lid with filter Quick lock Perforated aluminium floor with filter Figure 16: Principal design of a sterilization container Thermo Scientific 50112712_082007_GB...

  • Page 54: Loading The Sterilizing Chamber

    This is how the sterilization containers are loaded into the sterilizing chamber (9): Pursuant to Din 58953-9, “cloth” (wrapping cloth) not only refers to textile wrappings, but also to other materials with similar characteristics, such as steam permeability and drapability. Thermo Scientific 50112712_082007_GB...
  • Page 55 ♦ Check to see that the sealing surface on the door (1) and the door seal (7) are clean. ♦ Close the door (1) until it touches the sterilizing chamber (9). The door will lock automatically when the selected program has been started. Thermo Scientific 50112712_082007_GB...
  • Page 56 3. Sterilization containers are placed near the bottom, 4. Heavy instrument containers are placed in the lowermost position of the sterilizing chamber. This will clear the way for the condensate accumulating liberally on heavy sterilizing items to drip off. Thermo Scientific 50112712_082007_GB...

  • Page 57: Selecting Sterilizing Programs

    (18). ♦ Press the START/STOP key (20). The green START/STOP key (20) lights up. The door is automatically locked. The yellow control LED on the control panel (door indicator, 21) is lit. The selected program is started. Thermo Scientific 50112712_082007_GB...

  • Page 58: Settings

    After sterilization the preset program parameters are automatically restored. The next time you select a program with the program key (19), the preset settings appear again. You can set the drying time on the control panel (6): Thermo Scientific 50112712_082007_GB...

  • Page 59: Adjusting The Removal Pressure

    ▼ key (17) to display the timer settings, the current time and the durrent date. To change the settings for day / month / year or hours / minutes, press the program key below, and change the value using the ▲ key (16) or the ▼ key (17). Thermo Scientific 50112712_082007_GB...
  • Page 60 The indicator in the corner of the Timer key is lit. The cycle display (18) now shows the timer setting (Figure 22) with the current time and date on the first line (U) and the timer setting on the second line (T). Thermo Scientific 50112712_082007_GB...
  • Page 61 When using the Transport, Empty Jacket or Door seal service programs or the Vacuum & Empty testing program, activating the timer key will not keep the sterilizing chamber at working temperature. For the testing programs, the sterilizer must be cold. Thermo Scientific 50112712_082007_GB...

  • Page 62: Turning The Acoustic Signal On And Off

    The indicator light in the corner of the Preheating key is lit. The locking levers of the door are locked automatically. The door seal is not deaerated. The sterilizer preheats the double wall up to the maximum temperature of the previously activated sterilizing program. It does not switch off automatically. Thermo Scientific 50112712_082007_GB...
  • Page 63 ♦ Open the door (1). You can now perform another sterilization cycle. When the sterilizer is not busy with a sterilizing program and the Preheating key is deactivated, it will go into standby mode after 5 minutes. Thermo Scientific 50112712_082007_GB...

  • Page 64: Starting And Running A Program

    The sterilizer always returns to a safe state before unlocking the door. If the program is followed by a drying phase, the Current values display (15) shows the drying time and the ▼ symbol. The drying time counts down to zero. Thermo Scientific 50112712_082007_GB...

  • Page 65: Batch Documentation

    317 * Drying footer notice, signature field. 16:18 106.5 99 * 16:18 105.4 15 * 16:22 106.5 16:23 108.2 End of cycle 16:24 109.5 86 * ------------------------ Program cycle successful SIGN. Figure 24: Sterilization log (example) ======================== Thermo Scientific 50112712_082007_GB...

  • Page 66: Batch Documentation Evaluation

    - must not vary by more than ≤ 1.5 K, - must not differ by more than 2 K. The holding time must not be less than 15 minutes at 121 °C, 10 minutes at 126°C or 3 minutes at 134°C. Thermo Scientific 50112712_082007_GB...
  • Page 67 16:15 135.6 Recooling Pressure values 16:15 135.6 317 * Sterilizing times Drying 16:18 106.5 99 * 16:18 105.4 15 * 16:22 106.5 16:23 108.2 End of cycle 16:24 109.5 86 * ------------------------ Program cycle successful SIGN. ======================== Thermo Scientific 50112712_082007_GB...

  • Page 68: Program End And Removal

    You must wear heat-isolating protective gloves and long- sleeved working clothes when opening and loading the sterilizing chamber (9) and when removing the sterilized articles: Watch for hot surfaces and hot steam! ♦ Rotate the door (1) to the side. ♦ Remove sterilized items. Thermo Scientific 50112712_082007_GB...
  • Page 69 For information on how to activate the Preheating key, refer to Chapter 8.4. INFORMATION The door (1) should always be left open when the sterilizer is not in use. This will allow residual moisture to escape. Thermo Scientific 50112712_082007_GB...

  • Page 70: Maintenance Information

    We also recommend entering into a contract for maintenance or for annual safety checks. In Germany, pressure device repeat tests must be performed by an expert meeting the requirements of the Pressure Vessel Regulation, Section 32. Thermo Scientific 50112712_082007_GB...

  • Page 71: After-Sales Service And Maintenance

    Minimal additional quantities of e.g. oxidising or reducing substances may attenuate or aggravate the process. CAUTION For error-free operation and to avoid corrosion damage, carefully follow the maintenance manual. Thermo Scientific 50112712_082007_GB...

  • Page 72: Inserting Paper Rolls Into The Integrated Printer

    ♦ Replace the printer cover (27). Guide the paper through the slot of the printer cover (27). Once the printer cover is flush with the device, lock the printer cover by turning the locking bar to the right. Thermo Scientific 50112712_082007_GB...

  • Page 73: Changing The Ribbon Of The Integrated Printer

    ♦ Replace the printer cover (27). Guide the paper through the slot of the printer cover (27). Once the printer cover is flush with the device, lock the printer cover by turning the locking bar to the right. Thermo Scientific 50112712_082007_GB...

  • Page 74: Troubleshooting

    Error 5 Actual holding time (sterilizing time) Contact after-sales Holding time does not agree with selected service. sterilizing time. Error 6 Door seal loses pressure during Contact after-sales Compressor sterilization: service. Compressor defective, or leaking pressurized air system. Thermo Scientific 50112712_082007_GB...
  • Page 75 13 hPa. interior and repeat test. Contact after-sales service. Error 17 Maximum chamber temperature has Disconnect the sterilizer Overheating been exceeded. from mains immediately; if necessary, contact after-sales service. Thermo Scientific 50112712_082007_GB...
  • Page 76 20°C and device shows a chamber temperature of 3 °C Err3 Pressure sensor defective Contact after-sales service. in the Chamber Pressure sensor in sterilizing field: chamber in the Jacket Pressure sensor in jacket space field: Thermo Scientific 50112712_082007_GB...
  • Page 77 Or press the Preheating key (22) and the ▼ key (16) concurrently. Contact after-sales service. Sterilizer has performed 400 Replace the sterile air sterilization cycles. filter (see maintenance instructions). Table 2: Error codes and their meanings Thermo Scientific 50112712_082007_GB...

  • Page 78: Preparations For Transport (Frost Protection)

    ♦ Clean the sieve of the feed water tank under running water. ♦ Clean the entire sterilizing chamber as well as the feed water tank thoroughly with a moist soft cloth. Draining the vacuum pump ♦ Place the vessel below the screw cap (see picture). Screw cap Thermo Scientific 50112712_082007_GB...
  • Page 79 ♦ Press the ▲ key (16) or the ▼ key (17) on the control panel (6) repeatedly until cycle display shows the Transport program. ♦ Start the Transport program. Press the START/STOP key. Thermo Scientific 50112712_082007_GB...

  • Page 80: Recommissioning

    Following tests must be executed at commissioning: • Concordance with specifications • Calibration of the units concerning control, display and documentation • Checking measuring, controlling and regulating features • Checking operational safety • Checking vacuum-tightness • Checking consumables • Visual inspection Thermo Scientific 50112712_082007_GB...

  • Page 81: Packing The Sterilizer

    16 Packing the sterilizer 16 Packing the sterilizer VIII ♦ Pack the remaining accessories into the sterilizer as described on the content list. Thermo Scientific 50112712_082007_GB...

  • Page 82: Opening The Door Without Power

    When the sterilizer is reconnected to mains, the sterilization phase display may show an error message. ♦ Proceed as described in Chapter 14, Errors. DANGER If a program is interrupted, the load must be re-sterilized for safety reasons. Thermo Scientific 50112712_082007_GB...

  • Page 83: Technical Specifications, Abridged

    Traces of heavy metals (except iron, cadmium and lead) ≤ 2 mg/l Chlorides ≤ 0.5 mg/l Phosphates ≤ 5 μS/cm Conductivity (at 20 °C) pH value 5 to 7 Colour Colourless, clear, without residue ≤ 0.02 mmol/l Hardness Thermo Scientific 50112712_082007_GB...

  • Page 84: Glossary

    FRPV Fractionated prevacuum Fully deionized water Water from which all minerals and salts have been removed by ion exchange (anions for OH , cations for ) or reverse osmosis; not the same as softened water Infectious Catching Thermo Scientific 50112712_082007_GB...
  • Page 85 Unpackaged solid items, packaged solid items, packaged textiles and packaged hollow items to be sterilized Sterilizing temperature Temperature needed for sterilization Sterilizing time Time needed for sterilization Temperature sensor Thermometer Thermolabile Not stable when heated Toxic Poisonous Vacuum Negative pressure Thermo Scientific 50112712_082007_GB...

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