Getinge HS 6613 ER-2 Original User Manual
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Getinge HS 6613 ER-2 Original User Manual

Getinge HS 6613 ER-2 Original User Manual

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HS 6613 ER-2
UNITED DOCTORS HOSPITAL
2530290-090-01
Original User Manual

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  • Page 1 HS 6613 ER-2 UNITED DOCTORS HOSPITAL 2530290-090-01 Original User Manual...

  • Page 3: Table Of Contents

    TABLE OF CONTENTS PREFACE ........... . . 1 SAFETY .

  • Page 5: Preface

    In the event of an accident or incident you are obliged to report this. See “Reporting an accident or incident” under SAFETY GETINGE STERILIZATION AB shall not be liable for any damages, directly or indirectly, due to actions, which are not in accordance with this manual.

  • Page 7: Safety

    SAFETY Attention symbols Some of the warnings, instructions and advice in this manual are so important that we use the following special symbols to draw attention to them. The designs and symbols used are: Warnings This symbol indicates a warning in the text of the manual. It warns of a hazard that may lead to more or less severe injury and in certain cases mortal danger.
  • Page 8 Symbols on the unit Hot surface This symbol warns of a hot surface. Electrical danger This symbol warns of an electrical danger. Other dangers This symbol warns of other dangers. SAFETY...

  • Page 9: Reporting An Accident Or Incident

    The unit is a product in the GETINGE range. The unit may also be a sterilizer that is a medical engineering product and which conforms to the EU medical devices directive, or which is constructed in a similar way to a medical device.
  • Page 10 SAFETY...

  • Page 11: Introduction

    INTRODUCTION HS 66 HS 66 is the designation of a series of GETINGE high-pressure auto- claves with vertically sliding automatic doors, all with the door opening 660 x 660 mm There are both stand-alone and built-in versions. The autoclaves are intended for sterilization of materials in the health service as well as in industry.
  • Page 12 The control unit is therefore prepared for controlling an autoclave having a GETINGE ASF automatic loading and unloading unit. As with other GETINGE double-jacketed autoclaves, the external sur- face of the chamber is more than half covered by all-welded U-sec- tions..

  • Page 13: Overview Of Safety Devices

    For this reason, they must not be replaced with components of any make or design that has not been approved by GETINGE. It is of the highest importance that the operational reliability of these components is continuously upheld during their entire service life.
  • Page 14 Doors The doors are closed and locked while the process is running and remain locked in the event of media loss. The doors cannot be opened until the pressure in the chamber has been equalized with the ambient pressure, not even if fault management gives an opening command. The sliding doors are operated by a compressed air cylinder which has a severely throttled inlet.

  • Page 15: Built-In Electrical Steam Generator

    undesired flow through the valves in case of power failure. A fail safe function is achieved. Pressure vessels The sterilizer chamber jacket and steam generator are pressure vessels, designed and built in accordance with standards laid down by official bodies charged with monitoring this area of safety. The internal steam supply to the sterilizer is protected against excessive supply pressure by a safety on the steam generator, the sterilizer or both.
  • Page 16 When the key is in the safety valve check position, steam is produced continuously and regardless of the setting of the operating pressure switch. Water level regulation Version with conductive measurement The Getinge conductive level system is designed for water with a con- ductivity above 2 μS/cm. 12 - INTRODUCTION...
  • Page 17 The distance between the electrodes is another factor that affects the overall sensitivity of the level control system. Version with float The GETINGE float-based level control system is intended for water with a conductivity of 0 to 2 μS/cm, but it can also be used for higher conductivity.
  • Page 18 Overfilling protection The timer relay prevents the steam generator over-filling with feedwater if the level control system stops working. “Reset level button ” If a fault occurs on any of the safety components of the steam generator, it must be reset manually in accordance with applicable boiler regula- tions.

  • Page 19: The Process

    THE PROCESS The steam sterilizing process The universal steam autoclaving process can be divided into three main phases: A Pre-treatment B Sterilizing C Post-treatment Pre-treatment It has been found that moisture is an essential element in achieving ste- rility with steam. It is therefore important that the steam comes into close contact with the micro-organisms to be killed.
  • Page 20 When sterilizing liquids, the temperature is measured with a tempera- ture sensor in the load. The condition for countdown of sterilizing time is that both temperature sensors in the chamber and the sensor in the load indicate the programmed sterilizing temperature. Post-treatment The purpose of the post-treatment is to normalize the temperature and moisture content of the goods.

  • Page 21: Maintenance Program

    Maintenance program Leak test Fully automatic process for steam autoclaves With autoclaves equipped with an analogue pressure transducer the leak test can easily be automatically performed. The leak test is to be per- formed with an empty chamber. The chamber additionally has to have been warm, for example as a result of a heating program having been run beforehand.
  • Page 22 See Components in the TECHNICAL MANUAL for printer settings and maintenance. The system stores the last process so that an “emergency printout” can be produced afterwards if there is a problem with transmission of the printout or with the printer itself. If the system is fitted with a SUPERVISOR, the printer is connected to that.
  • Page 23 HEATING 00:08:50 115.8 132.5 115.6 1.880 00:08:33 107.8 132.6 104.3 1.107 POS PULSING 00:08:14 115.9 132.5 115.7 1.876 00:07:57 107.2 132.6 103.1 1.103 POS PULSING 00:07:38 116.0 132.6 115.7 1.880 00:07:21 106.0 132.6 100.1 1.119 POS PULSING 00:07:02 116.1 132.2 114.9 1.877 00:06:44...

  • Page 24: Documentation Of The Process

    AI01 JACKET TEMP A100 DRAIN TEMP SIGNALS DRYING AIR PULSE 00:00:00 DRYING STEAM PULSE 00:00:00 DRYING TIME 00:05:00 STERILIZING TIME 00:04:00 STER. TEMP. 134.0 C POS. PULSE NEG. PULSE PARAMETER SET- TINGS CYCLE COUNTER MACHINE NAME :HS55 PROCESS START 13:20:45 DATE 29/06/2004 1.
  • Page 25 Printout is possible in four modes. The mode shown below is preset before delivery and is recommended by GETINGE. The system stores the last process so that an “emergency printout” can be produced afterwards if there is a problem with transmission of the printout or with the printer itself.
  • Page 26 PROCESS START : 08:01:36 NEG. PULSE AUTOCLAVE NAME : HS6613-2 POS. PULSE AUTOCLAVE NUMBER STERILIZING TEMP134.0 C CYCLE COUNTER STERLIZING TIME 00:07:00 DRYING TIME 00:05:00 DRYING STEAMPULSE 00:00:00 DRYING AIRPULSE00:00:00 PROGRAM: P1 POROUS LOAD 134 ----------------------------------------------------------------------------------------------------------------------------------------- CHAMBER PRESS DRAIN TEMP 0 .

  • Page 27: Instruments

    INSTRUMENTS Loading side Steam supply pressure gauge. Control switch. Pressure gauge chamber pressure. Door interlock key Operator's control panel Emergency stop. Panel lock. Operator's control panel Learn the function of the control panel by studying chapter Control unit PACS 3500. Door-blocking key See chapter Introduction, “Safety devices, an overview”.
  • Page 28 Unloading side Recorder for temperature and Operator’s control panel pressure. Pressure gauge chamber pressure. Emergency stop. Recorder See recorder operating instructions in the TECHNICAL MANUAL chapter Components. Operator.s control panel Learn the function of the control panel by studying chapter Control unit PACS 3500.

  • Page 29: Operation

    OPERATION Program start Where applicable, the operator must state process parameters and other information requested by the control system. On equipment where an authorisation code for programs not intended for routine sterilization is activated, the operator must also enter an authorisation code immedi- ately after startup.

  • Page 30: Alarms - Avanti

    Authorization protected programs only: After the start button is pressed, the operator is [START] requested to enter the authorization code. Message If the operator chooses to attempt to start the sterilizer, even though starting is blocked, the operator panel display shows a message refer- ring to an essential condition that is not met.
  • Page 31 • An alarm signal goes off and the relevant fault code is displayed on the cycle screen, while the cycle screen’s background turns red. • After the alarm signal goes silent, the Alarm indicator in the status field blinks. • If the unit is equipped with a printer, the alarm text is also printed out as part of the cycle log.
  • Page 32 Alarms in standby mode An alarm from an idle sterilizer prevents it being started. • Call a technician. If the load contains liquids, choosing the wrong program may endanger personnel and equipment. Alarms during a cycle / Avanti A fault occurring during a cycle stops the cycle. All valves close in order to stabilize the conditions in the chamber.
  • Page 33 • If the unit is equipped with a printer, the alarm text is also printed out as part of the cycle log. Call a technician. In case of a serious fault, always call a technician. After the technician activates the key switch to the Stepping/Authorized user setting, the technician has the following alternatives: •...
  • Page 34 • Press More • Press to acknowledge the alarm, by which the Ack. Alarm indicator goes out and the red background disappears. To reset certain types of faults, a technician must first activate the key switch for Stepping / Authorized users. Repeated alarms If the process repeatedly hangs at the same alarm point, call a technician to step the process to the end.

  • Page 35: Error Codes

    NOTE! Important where a steam generator safety valve has been blowing off for a long time and the chamber is under pres- sure at the same time. Only switch off the sterilizer control switch as a last resort, because doing so disables certain safety functions. Instead, call a service technician who can trip the steam generator circuit-breakers.
  • Page 36 Error code/ Explanation Message AI FAIL- Jacket temperature sensor defective. JACKET AI FAIL- Pressure transducer defective. PRESSURE AI FAIL-LOAD Load temperature sensor defective. NOTE: Not present on all sterilizers. AI FAIL- De-aeration temperature sensor defective. DEGASS. NOTE: Not present on all sterilizers. Mistakes when correcting the above types of faults may lead to situations where there is a risk of injury.
  • Page 37 Error code Explanation LOW TEMPER- The chamber temperature has been below the ATURE permitted limit during the sterilization phase. PHASE TIME- The phase named on the display exceeded the time limits for completion. Check whether the cause is a component fault or media fault. POST.

  • Page 38: General Advice When Using The Sterilizer

    Error code Explanation TEMP. INTER- The independent safety interlocking of the LOCK door function, as controlled by the load tem- perature switch, or the Supervisor, is faulty. NOTE: Not present on all sterilizers. I/O FAULT The control system has lost communication with the input or output cards.

  • Page 39: Weekly Cleaning - Avanti

    Fire hazard There have been reports of textile loads catching fire in the sterilizer chamber. In all cases this has been due to the load becoming excessively dry and hot. This can happen in two ways: • The load has been placed in a heated chamber and left for a long time without the process being started.
  • Page 40 The sterilizer should have cooled down before cleaning. When the key switch cannot be constantly observed, the person doing the cleaning must always take the key with them. This is to ensure that no-one mistakenly resets the key switch. • Clean the strainer in the chamber floor drain.

  • Page 41: Approved Consumables

    The list of consumables below is intended as a guide to be used with GETINGE’s CE-marked sterilizers. Always check whether consumables have a use-by date before using them.
  • Page 42 Getinge AB recommends using chemical indicators in steam steriliza- tion processes. For other types of processes it the user’s responsibility to evaluate whether individual makes are applicable to the GETINGE sterilizer process. An established test method in which chemical indicators are used is the Bowie-Dick test, with test packages or its equivalent with a disposable package.
  • Page 43 As a result, only equipment that has been evaluated by Getinge AB and registered as approved equipment may be used together with the sterilizer. Should non-approved equipment be used, Getinge AB exempts itself of all product liability for the sterilizer and its CE label.
  • Page 44 Rails for AGS Support bar (Rails for basket Loading Platform Loading Module L-Rails (Extendable Shelves) Extendable Shelves (perfo) Extendable Shelves (Wire) Sterilizer Basket (DIN) (600*300*150/290) 600*400*115/150/290) Sterilizer Basket (ISO) (100) / (200) Sterilizer Basket (SPRI) (100) / (200) Sterilizer Basket (SPRI- Swedish) (100) / (200) Automatic Loader (Basket) Automatic Unloader...
  • Page 45 LT FIXED SAL PD 6610/ 633-10 LT FIXED SAL PD 6613/ 633-13 LT H/A 6610/6620HL/6910/ 633-10 LT H/A FOR 6613/6913/ 633-13 LT H/A FOR 6617 LT H/A SAL 6x10/633-10 LT H/A SAL 6613/6913/ 633-13 LT H/A SAL PD 6x10/633- LT H/A SAL PD 6x13/633- Other accessories.
  • Page 46 42 - OPERATION...

  • Page 47: Operation Instructions

    OPERATION INSTRUCTIONS The following operating instruction deals with the day-to- day use of the sterilizer. A further copy of this operating instruction, together with the program combination, is packaged with the sterilizer when it is dispatched from the factory. These documents must be displayed so that the personnel can read them when working at the operator panel.

  • Page 48: Daily Preparations

    Daily preparations • Learn the functions of the control buttons and signal lamps by stud- ying the Instruments and Control unit chapters. Find out how the user-programmable parameters are set on this unit. • Open valves for water, air and, where applicable, steam. •...
  • Page 49 If the lamp does not light up, start is prevented for some reason (also see chapter Operation and Control unit). • Choose the cycle by pressing the Cycles button in the button field. In order to run the latest cycle, this step can be skipped.
  • Page 50 Goods handling Remember that the goods may contain a considerable amount of heat when unloaded. Position them with regard to a good working environ- ment. Note that the goods may be very hot immediately after unloading. Let the goods cool down or wear safety gloves to handle them.
  • Page 51 To interpret the “Finished cycle” indicator Normal routine cycle: After completion of fault-free nor- mal routine cycle, the indicator shows a steady green light. Maintenance cycles: After a completed, fault-free auto- matic leakage test or filter steriliza- tion, for example, the indicator shows a flashing green light.
  • Page 52 On power failure or if the control switch or working switch of the sterilizer had to be turned off during a process, there is a risk of leakage at the door. Safety measure when there is positive pressure in the chamber: KEEP WELL AWAY FROM THE DOOR AND CALL A TECH- NICIAN! ALWAYS LEAVE THE PREMISES and call a technician if...

  • Page 53: Control Unit Pacs 3500

    CONTROL UNIT PACS 3500 The letters PACS stand for Programmable Autoclave Control System. The purpose of the control system is to issue orders and send them to the executive components of the unit so that a number of process steps are performed in accordance with a predetermined template.
  • Page 54 A number of special terms STERILIZATION refers to the entire series of treatments that make up a process aimed at achieving the total killing of all living organisms. This applies to sterilizers and usually includes air removal, heat treat- ment and a drying phase. STERILIZING refers to the actual killing part of the process, the heat treatment.

  • Page 55: Control Panel Type Avanti

    Control panel type Avanti General description Screen The screen can be divided into three areas: status field, middle field and button field. Status field The status field is displayed in all cycle images. The field contains information about the machine's current status, such as the current cycle and phase and the time these have lasted.
  • Page 56 Middle field The middle field is specific for the screen and displays unique functions and information for the respective menus; see the section Screens in the Main Menu chapter. Button field The button field shows the application buttons that are used to give commands.
  • Page 57 Buttons and symbols Symbol Operation Description Indicators Doors locked The machine’s doors are closed and locked. Doors closed The doors of the machine are closed. Cycle in progress The machine is processing the selected cycle. Completed cycle Steady light: Normal cycle concluded without warnings or errors.
  • Page 58 Help Buttons No function. For information, see "User Manual" or "Service manual." Cycles Open menu to select cycle. Note: Not displayed on the unloading side. Home Display latest start screen. Back Return to the previous window or menu, or undo the input. Back Alarm Display menu for alarm history.
  • Page 59 Close Close machine door. More Optional when alarms or preprogrammed functions are active. Alarm- Silence alarm Switch alarm signal off. signal handling Informa- Cycle Provides information about tion information current process and phase, as well as the time these have been going on for.
  • Page 60 Scroll list If there are more rows than space available on the screen, a scroll list is displayed on the right. To reach the row above or below, just drag the button. The various states of the buttons Active The button can be pressed Pressed The button is pressed.
  • Page 61 Pop-up windows and dialogue windows Alarm pop-ups Shown below is an example of an alarm pop-up. In the event of an alarm, the current alarm displays as a pop-up window on the screen and an alarm sounds. For alarm management, see the "Alarm"...
  • Page 62 The window remains on the screen until a selection is made by pressing the desired button. Green information window The window and an acknowledgement button lights up to signal that the process is ready. An audible signal sounds. The window remains on the screen until the acknowledgemente button is pressed or the door is opened automatically.
  • Page 63 Inputting window Here are two examples of inputting windows. To enter a name, press the desired letters. To toggle between small and capital letters, click the arrow up button down to the left. To switch to a numeric keyboard, press the button with numbers at the bottom left.

  • Page 64: Operator Menu Avanti

    Operator menu Avanti Description of menus and functions Start screen The start screen allows access to the main functions for starting a cycle. Open/Close door. The door is opened and closed with the buttons, Open Close respectively. Cycle selection Cycles are selected with the button in the bottom left corner of the button field.
  • Page 65 To select a cycle, press the desired cycle. The previous screen is displayed again. The selected cycle is displayed in the top left corner of the status field. Note! The function is not available from the unloading side. Start cycle Selected cycles are started with the button.
  • Page 66 The following information is displayed: • Machine name • Application version • Panel version • PACS version • PROM date • Serial number • Total amount of cycles Other menus require a password and are described in the Service Manual. Screens Circle graph The start screen shows a pie chart and three cycle parameters.
  • Page 67 The following cycle parameters are displayed: • Current chamber temperature • Current chamber pressure Plot graph The start screen displays a plot graph with various cycle parameters. The status field also shows other cycle parameters. The remaining cycle time is displayed to the right in the status field. The following cycle parameters are displayed in the status field: •...
  • Page 68 In order to enlarge the graph, press . When the graph is enlarged Zoom in it is possible to navigate by pressing somewhere on the screen and then dragging with a finger. Details Graph The start screen displays a list of parameters that shows information about the system and the current cycle.
  • Page 69 The following alarm information is displayed: Error Description of the alarm. Date The date when the alarm triggered. Time The time when the alarm triggered. Phase The phase that was current when the alarm triggered. Sub-phase The sub-phase that was current when the alarm triggered.
  • Page 70 66 - CONTROL UNIT...

  • Page 71: Program Combination

    Program combination 2530290-090 Liquids must not be processed with any of these programs. Hazardous waste and explosive materials must not be processed in this sterilizer. Door blocking key The door does not close when the key is in the locked position and the door is in open position, as indicated by the symbol.
  • Page 72 P 0 4 Bowie & Dick test Password required! RAX2003 Parameter Range Delivered Actual Negative pulses - - - ....Positive pulses - - - ....Sterilizing temperature °C 121 - 135 ....Sterilizing time 0 - 15 ....Postvacuum time 0 - 90 ....
  • Page 74 Print date 2014-06-30...

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