EN-US - Getinge Infection Control
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1. e Parameter Check provided a calculated numeric process lethality e Summary verification of time at selected temperature min max exposure values e Cycle verification signature line Paper roll is replaced by a drop in and quick feed method and the printed strips can be either accumulated on an automatic take up reel or torn off for individual cycle storage A paper feed switch is provided along with a switch for printing a duplicate of the last cycle For backup informational purposes the same cycle performance data is also automatically sent to a USB flash drive port in the control tower A USB memory module is supplied with each unit and will hold approximately 10 000 cycles This backup cycle data can be sent directly to a USB printer in lieu of the USB flash drive A NetCOM communications card is provided standard as part of the control system of each unit The NetCOM is providing all of the cycle performance data to the USB port device NetCOM also supports a separate Ethernet connection between the sterilizer and the following external data management systems See Note e T DOC Instrument Tracking and Asset Management e T DOC Data Logging storage and printing e Getinge Online web based remote monitoring Note Separate equipment and setup required including network Ethernet cable drop by customer for each sterilizer Internet accessibility may be required Refer to arrangement drawing and contact your Getin2. Column LJ Left Hand Hinged Right Hand Control Column shown DOUBLE DOOR UNIT LJ Recessed both ends DOUBLE DOOR DESIGNATIONS O Control End CE Door Right Hand Swing Left Hand Control Column Remote End RE Door Swing and Column opposite Q Control End CE Door Left Hand Swing Right Hand Control Column Remote End RE Door Swing and Column opposite CONTROL PANEL LOCATION LJ On Unit O Wall Mounted GETINGE GETINGE GROUP Floor Mounting O Depressed Pit Mounted for level loading O Floor Mounted with Scissor Lift O Floor Mounted for use with Transfer Carriage ELECTRICAL SUPPLY Sterilizer 1 115V 1Ph 50 60 Hz O 230V 1Ph 50 60 Hz STEAM SOURCE O House steam LANGUAGE SELECT ONE O English O French O Spanish LOADING EQUIPMENT O 4003 Floor Loading Cart with 3 Shelves Qty O 4004 Transfer Carriage Qty __ _ O 4003RC Floor Loading Cart for Transfer Qty _ _ _ OTHER STERILIZER ACCESSORIES amp OPTIONS O Air Compressor O Auto Blowdown Control for stand alone electric boiler O Steam Separator Tank for Auto Blowdown O Water Saver Package for Vacuum Ejector Models only O 115V O 230V 115V Water Chiller Unit for Water Saver House chilled water COIL in lieu of electric Water Chiller Limited Access Kit Hinged control tower Uninterrupted Power Supply UPS Provides control power for up to 30 minutes to complete a cycle in process Vacuum ejector models only O T DOC Pa
3. Avanti touch screen PERFORMANCE When installed and connected to specified utility services the system provides accurate and repeatable performance During the timed exposure phase the temperature will be controlled by the chamber sensor at 1 1 F 0 6 C above the set point 0 1 C Temperature selectivity is in 0 1 F 0 1 C increments Timing functions are selectable in one second increments and accuracy is within 0 04 Temperature is controlled by a time proportioning continuous algorithm called Proportional Integral Pl A battery with a 10 year life holds programmed cycle values in memory In the event of a power interruption current cycle status is stored for up to 1 minute DESIGN CONSTRUCTION The chamber is constructed of an inner shell reinforced by a series of U channels that form the outer jacket of the chamber The gasket ring and backhead on single door models are formed and welded to the chamber body Chamber and door material is 6 mm 0 236 thick stainless steel Type SA240 316Ti The jacket material is also 316Ti stainless steel The interior chamber finish is polished to a high luster finish All pressure vessel construction meets ASME code requirements for working pressures up to 45 psig 810 kPa The gasket ring holds a continuous one piece silicone gasket 0 787 20 mm in diameter The body assembly is thermally insulated with 1 5 fiberglass insulation and is double thick between t
4. CUSTOMER REFERENCE 833HC E SERIES VACUUM GRAVITY STEAM STERILIZERS FOR HEALTHCARE APPLICATIONS PRODUCT SPECIFICATION PRODUCT The Model 833HC E Vacuum Gravity Steam Sterilizer employs both gravity downward displacement with positive pulse conditioning and pressure vacuum pulsing for dynamic air removal Up to 17 cycles can be easily accessed in two easy steps Custom cycle names can be designated for each cycle and each cycle can be reconfigured for easy access All cycle phases are sequenced and monitored by the control system providing both audible and visual notification of deviation from certain operating parameters APPLICATION For general purpose gravity or vacuum steam sterilization of hospital instruments and supplies The selectable temperature range is from 230 F to 275 F 110 C to 135 C and from 219 F to 275 F 104 C to 135 C for liquid cycles Typical applications include wrapped and unwrapped porous and non porous hard goods gowns or towel packs and liquids in self venting or unsealed containers The liquid exhaust is microcomputer controlled for linear and consistent liquid cool down programmable within a specified range MODEL SELECTION LJ Standard O Optional CHAMBER DIMENSIONS 26 5 672mm wide x 62 1575mm high O 42 long 1067mm 39 6 Cu Ft 1120L O 76 long 1930mm 72 0 Cu Ft 2040L SINGLE DOOR UNIT C Recessed Only SINGLE DOOR DESIGNATIONS LJ Right Hand Hinged Left Hand Control
5. P1 0 01 01 53 grv GRAVITY1 00 25 48 04 EXPOSURE 00 30 00 Exposure Time 121 1C Exposure Temp 00 30 00 DryingTime The Status Field across the top of the touch screen identifies the selected cycle number cycle name and current cycle phase on the left side Cycle status and door status are displayed on the right side Text alarm messages and non critical system messages are displayed in the central area The Middle Field of the display screen shows actual real time cycle information in the optional format selected Cycle parameters such as exposure time exposure temperature or drying time can be changed with the proper password clearance Simply tap the value on the screen and input the new parameter value Changes must be acknowledged and saved by the user Note Adjustment of time and temperature parameters requires user validation of the cycle efficacy Factory recommended cycles are validated to ANSI AAMI ST8 User Access The PACS control system is operated via an easy to use menu system By default the user has access to the cycle selection door control and cycle start Users can run only validated cycles Access to other areas such as running test cycles re setting parameters calibration service and maintenance is controlled by pre defined password access Refer to the MENU tree in the User Manual Tap the MENU button to see the following sub menus e System Menu e Process Screen e Documentatio
6. a Load Carts to be used for storage prior to sterilization holding for cool down following sterilization and for transportation of sterile goods to surgical suites j e 1 b mu j Bae TT 4 ut gt a pe i it A Whe rt WA F n Models 4004 Carriage and 4003RC Load Cart TECHNICAL DOCUMENTATION 6013078801 800 E Installation Arrangement Drawing Floor Mount LH Door CE 6013095701 800 E Installation Arrangement Drawing Floor Mount RH Door CE Model 4003 Floor Loading Cart 6013095801 800 E Installation Arrangement Drawing Pit Mount LH Door CE When the 800 Series sterilizer must be installed directly on aai POOE Sa AoT Aranen Drawing the floor the chamber loading position will be elevated One Pit Mount RH Door CE solution is to utilize the Model 4004 Transfer Carriage with the Model 4003RC Floor Loading Cart The 4004 Transfer 800 E Pit Drawing 42 LH Door CE Carriage is used to support the 4003RC Cart in the proper elevated position while the cart is loaded with instrument 800 E Pit Drawing 76 LH Door CE sets and wrapped goods The carriage with load cart is docked with the sterilizer and the load cart is pushed off the P carriage into the chamber This action is reversed to 800 E Pit Drawing 42 RH Door CE remove the load cart from the chamber An alternate solution is to order the sterilizer with an integrated SCISSOR 800 E Pit Drawing 76 RH Door CE LIFT to raise and lowe
7. c door Power door guards Panels cover moving parts of the door as it slides into locked position Heat guards and insulation Heat guards and insulation are standard on surfaces where operators routinely come into contact with the door or chamber opening during loading and unloading operations CONTROL SYSTEM Getinge Sterilizers employ the PACS 3500 modular PLC control system to monitor and control all sterilizer operations and functions The control system is factory programmed with standard sterilizing cycles Each cycle is adjustable to meet specific reprocessing requirements All user accessible control functions can be changed with appropriate password using the touch screen interface panel The E Series control system consists of a user interface panel called AVANTI the CPU controller a NetCOM communications card a thermal printer mechanical chamber and jacket pressure gauges status indicators and controls On Off switch A key lock is provided to insure all door power is disconnected when working in the chamber Controls are located next to the door in a vertical column for convenience If specified the control column can be located remotely from the sterilizer with up to 32 8 feet 10 m of cable An RS 232 port is provided for serial communications for central data collection or remote service analysis and is ready for T DOC connection The AVANTI user interface panel is a durable 8 4 inch diagonal SVGA color to
8. ckage for Instrument Traceability amp Asset Management including T DOC Cycle Getinge Online for remote connectivity to view real time sterilizer process data Requires CAT 5 type Ethernet cable to connect hospitals network or existing internet connection to the machines NetCOM card Cabling is client s responsibility SEE ARRANGEMENT DRAWING O0O00 O QUALITY STATEMENT Confidence in the Getinge Group is the most important quality criterion This must be the hallmark of all our external and internal commitments activities and products Products and services supplied by Getinge must conform to the agreed terms and expectations to ensure recommendations for further business The achievement of these quality goals is the basis for a continued competitive and successful enterprise STANDARDS AND CODES The sterilizer shall comply with or meet the requirements of e ASME Section VIII Division 1 Code for Pressure Vessels Canadian Registration Number CRN Pressure Vessel Design Uniform Plumbing Code ETL Listed to UL 61010A 1 and UL61010A 2 041 ETL Listed to IEC 61010 1 and IEC 61010 2 040 cETL Listed to CSA C22 2 Nos 1010 1 and 1010 2 041 Seismic Anchoring Requirements per CBC Cycle Performance Validated to ANSI AAMI ST8 2008 STANDARD SAFETY FEATURES Steam interlock door switch Prevents steam from entering the chamber when the door is not sealed Steam safety valves Ensure that the pressure in
9. ge representative for details AVANTI User Interface Features The AVANTI touch screen serves as the users command and control center The screen is divided into specific sections to display cycle selection operation and process performance information in a consistent manner Bar Graph Displays temperature and pressure in a bar graph with a large easy to read digital time remaining display in the center Cycle time is the average of the last three cycles of each cycle type lal 122 1 C Chamber PSIA COREE PSI P10 01 01 53 grv GRAVITY1 00 25 48 04 EXPOSURE Chamber Temp OO t C SO 00 36 Remaining time The Button Field across the bottom displays the application buttons that are used to give commands e Cycle Select Tap to access and select from 23 recommended factory cycles Login Tap to access password protected features Menu Tap to select operating screen displays Door controls Use to open close and seal doors Cycle Start Turns green when conditions are OK to start a cycle Tap to start cycle Four process display screens are available to show important cycle information in different formats for ease of recognition The optional screens are e Bar Graph e Circle Graph e Details Display e Plot Graph Circle Graph Displays remaining time as a large easy to read graph that fills the circle as time elapses Cycle time is the average of the last three cycles for each cycle type 3 jal
10. he jacket U channels A steam baffle is provided to prevent condensation from wetting the load An extra threaded opening permits passage of thermocouple leads to monitor interior and load temperatures Steam connection to the chamber and jacket is 316L stainless steel material A manual gasket retract valve is provided for emergency chamber access Door Operation The door operation is powered by an electric motor and is actuated by a switch The open motion is in two steps First a slide to clear the door locking pins then it swings open The door will stop automatically if an obstruction is encountered In an emergency the power door can be opened manually by a qualified technician At the beginning of the cycle steam pressure behind the gasket automatically seals the door and retracts automatically at the end of the cycle Sealing is positive and consistent The gasket is recessed for added protection and long life Once the cycle begins and the chamber is pressurized the door cannot be opened A safety switch prevents steam from entering the chamber when the door is not in the closed and sealed position The door is insulated with fiberglass insulation and covered with a stainless steel panel Paneling The control panel and paneling is constructed of nominal 0 050 1 27 mm No 3 brushed finish stainless steel and is hinged for easy access to electronic components The trim panels are built in to fit within a recessed wa
11. ll CONSERVATION FEATURES The 800 Series is provided standard with a vacuum water ejector for dynamic removal of air from the chamber Specify the Water Saver or Water Saver with Water Chiller option to reduce water consumption by as much as 80 or greater depending on load and cycle conditions Building chilled water loop can be used to cool down the recirculating vacuum ejector water in lieu of the electric water chiller Validated tray loads increased from 16 pounds 7 3 Kg to 25 pounds 11 3 Kg per tray while vacuum pump cycle time decreased 600 pounds of instruments can be processed in a single cycle of the full size 76 Model 833HC E A screen saver extends the life of the backlit LCD and saves energy Touching the panel illuminates and reactivates the display The temperature of the discharge water is controlled by a temperature device to be less than 140 F 60 C This switch also conserves cold water by cooling the drain effluent only when it is needed Automatic utilities control feature provides a seven day timer for programmed startup and shut down of the sterilizer When activated the Control System automatically shuts OFF water and steam valves to the sterilizer conserving energy Cycles running beyond the programmed shutoff time will be completed prior to shut down Sterilizer utilities can be re started manually or by programmed time ENVIRONMENTAL IMPACT Getinge steam sterilizers are designed and constr
12. n Password Required e Alarm History Details Display When the Details Screen is selected the center area of the screen displays real time process data in text form The remaining cycle time is displayed to the right of the text field 00 00 00 grv GRAVITY1 2 P10 09 24 15 01 STANDBY i Chamber Temp 25 f C Chamb Press PSIG 0 00 PSI S Jacket Temp 137 4 C Atmosphere PSIA 14 49 PSI Chamber PSIA 14 49 S Drain Temp 92 3 C Exp Temp Max 276 2 C _ Exp Temp Min 275 8 C Steam Diff 141 6 KPA Time at Exp Temp PT Pq amp p2 Biia Login Menu More Close Plot Graph The start screen displays a plot graph of various process parameters Each process parameter is displayed in contrasting colors Additional process parameters are displayed in the status field The remaining time is displayed to the right of the status field 00 00 00 vac PREVAC2 P10 00 24 15 01 STANDBY 2 geo soc ogo 00 00 lt R 25 8C i 14 49 PSI J 118 1C j E PSI 150 0 50 00 120 05 40 00 90 0 30 00 60 0 20 00 30 0 10 00 00 00 00 04 00 08 00 12 00 16 00 20 Time _ P1 IIC a a a Cycles Login j Menu J More Close SU 0158 Supervisor Access A start up password is provided with the sterilizer for establishing first time password access for defined users supervisors Use the special supervisor password to access and
13. r the load cart for loading and Getinge USA Inc 1777 East Henrietta Road Rochester New York 14623 USA Phone 800 475 9040 Fax 585 272 5033 GETINGE GETINGE GROUP Getinge Infection Control is the world leading provider of solutions for sterile processing in the healthcare sector We aim to ensure the highest quality and safety at the lowest total cost We offer complete solutions for a seamless work flow reducing the risk of contamination while helping healthcare to increase efficiency Getinge Canada Ltd 6685 Millcreek Drive Unit 3 Mississauga Ontario LON 5M5 Canada Phone 905 363 4150 GETINGE GROUP is a leading global provider of equipment and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences We operate under the three brands of ArjoHuntleigh GETINGE and MAQUET ArjoHuntleigh focuses on patient handling and hygiene disinfection DVT prevention medical beds therapeutic surfaces and diagnostics GETINGE provides solutions for infection control within Healthcare and contamination prevention within Life Sciences MAQUET specializes in therapeutic applications products solutions and services for OR and ICU ge USA Inc Printed in U S A ArjoHuntleigh Getinge and MAQUET are registered trademarks We reserve the right to make changes to specifications and product information HC_ST_PS_833HCE_0214 1_EN_US 2014 Getin
14. setup the following Refer to the MENU tree in Appendix C of the User Manual e Access the system About section to identify the model and software version number e Add new users with passwords e Adjust system menu for setting the calendar e Select language date format and temperature and pressure measurement e Re order and or re name cycles e Edit cycle parameters e Activate utilities control feature to shut off water and steam to the sterilizer to conserve energy e Print the last cycle FACTORY DEFAULT CYCLES MODEL 833HC E 17 Cycles total 275 F 135 C Prevacuum Cycle 6 total For sterilizing double wrapped instrument trays up to 25 Lb 11 3 kg per tray or fabric packs gt 275 F 135 C sterilize temperature gt 3 minutes exposure gt 16 minutes dry time 270 F 132 C Prevacuum Cycle 1 total For sterilizing double wrapped instrument trays up to 25 Lb 11 3 kg per tray or fabric packs gt 270 132 C sterilize temperature gt 4 minutes exposure gt 16 minutes dry time 250 F 121 C Gravity Cycle 3 total For sterilizing double wrapped instrument trays up to 25 Lb 11 3 kg per tray or fabric packs gt 250 F 121 C sterilize temperature gt 30 minutes exposure gt 30 minutes dry time 275 F 135 C Gravity Cycle 3 total For sterilizing double wrapped instrument trays up to 25 Lb 11 3 kg per tray or fabric packs gt 275 F 135 C sterili
15. the chamber and or jacket do not over pressurize Door obstruction shut off Safety clutch stops the door movement if an obstacle is encountered After a short time out the motor will be shut down Analog chamber gauges Needle style gauges provide real time pressure readings in the jacket and chamber even in the event of a micro computer control system outage Program check The control system validates all user programmed adjusted cycle parameters against sterility assurance levels for safe effective cycle recommendations A warning appears if user s parameters do not satisfy the program s SAL calculation Password protected menu tree All levels of cycle changes and parameter adjustments require supervisor password or service password Abort alert Aborted cycles result in a warning message that requires user intervention before the chamber can be re opened Gasket retract valve Allows door gasket to be manually retracted in the event emergency access to the chamber becomes necessary Door safety baffle In the unlikely event of a catastrophic door failure the gasket will blow out and a baffle at the chamber mouth directs steam away from areas where users might be working Water alarm High water levels in the drain that cannot be corrected automatically will result in an audible alert Door motion alarm An audible alarm chirps throughout the opening and closing motion of the power automati
16. to the chamber for a timed period followed by a series of positive pressure pulses to remove chamber air b Heat Up to selected temperature c Exposure selected chamber temperature is attained and timed d Exhaust chamber vented to atmospheric pressure e Dry filtered air is drawn through chamber for the dura tion of time selected Either Gravity or Vacuum Dry is selectable Vacuum Dry is recommended f Cycle Complete signaled by a tone light and display message on the Avanti touch screen e Prevacuum Wrapped Goods Vacuum pressure pulsing conditioning a Conditioning steam flows into the chamber for a timed period followed by a series of pressure vacuum pulses to remove chamber air b Heat Up to selected temperature c Exposure selected chamber temperature is attained and timed d Exhaust chamber vented to below atmospheric pres sure e Dry a vacuum is created for the duration of the time selected Filtered air is admitted at the end of the drying time chamber to atmospheric pressure Cycle Complete signaled by a tone light and display message on the Avanti touch screen h e Liquids a Conditioning steam flows into chamber for a timed period to remove air b Heat Up to selected temperature c Exposure selected chamber temperature is attained and timed d Exhaust an adjustable linear exhaust e Cycle Complete signaled by tone light and display message on the
17. uch screen display Jacket Chamber Pressure Pressure Gauge Gauge GETINGE SENINGE GROUP Touch Suraan Command Buttons that Operate the Sterilizer Printar CONTROLS OFF ON USB Port CONTROLS behind panel DISABLE ENABLE on right side with key Audible and visual feedback is provided to users when a selection is made or a fault message is displayed Temperature can be set controlled and displayed in degrees Celsius or Fahrenheit Pressure is preset to be controlled and displayed in PSI AVANTI user interface display is mounted at both ends of the pass thru sterilizer for full control capabilities at either door Cycle Performance Documentation The Getinge 833 E Series sterilizer provides three standard means for cycle documentation e Paper printer e USB flash memory drive e NetCOM Ethernet connection The paper printer documents cycle performance using special thermal paper for a permanent record Thermal printing allows for quiet operation The printer is located on the control panel below the touch screen and documents the following on a 200 dpi dot matrix printer with 1 88 47 6mm wide paper e Process start time and date sterilizer name and number daily cycle number and total cycle count e Cycle selected with time and temperature with other adjustable parameters identified e Cycle phase transition points temperature pressure and total cycle time e Process fault information messages with time of occurrence
18. ucted with Our environment in mind To aid in the conservation of natural resources and in recognition of prevailing Environmental Policies particularly ISO 14001 Getinge steam sterilizers are more than 90 by weight recyclable Under normal operation Getinge steam sterilizers produce no harmful byproducts The steam sterilization process in and of itself produces nothing more than hot drain water WARRANTY Getinge USA Inc warrants that each sterilizer is carefully tested and inspected and leaves the factory in proper working condition free from visible defects Sterilizers are warranted for one year from the start of the warranty including parts and labor excluding expendable parts The ASME pressure vessel is further warranted to the original owner against structural failure for a period of 15 years from the date of initial operation See warranty pamphlet for complete details MATERIAL HANDLING ACCESSORIES e a gt ry D X H A y R wo sal When the 800 Series sterilizer is installed in a recessed pit the chamber will be loaded at floor level Wrapped sets and container sets are arranged on the shelves of the Model 4003 Load Transfer Cart and loaded directly into the chamber Each load cart is validated for 12 instrument sets with a weight of 25 Lbs each The 42 Model will hold a single cart with 12 sets The 76 Model will hold two load carts for a total of 24 instrument sets Order several extr
19. ze temperature gt 10 minutes exposure gt 30 minutes dry time 270 F 132 C Gravity Cycle 1 total For sterilizing double wrapped instrument trays up to 25 Lb 11 3 kg per tray or fabric packs gt 270 132 C sterilize temperature gt 15 minutes exposure gt 30 minutes dry time 273 F 134 C Vac Bowie amp Dick Test Cycle 1 total For conducting B D tests of prevacuum sterilizer using a validated test pack gt 273 134 C sterilize temperature gt 3 1 2 minutes exposure gt zero minutes dry time 268 F 131 C Vacuum Leak Test 1 total For testing the vacuum integrity of the sterilizers piping Note Vacuum leak test parameters are not adjustable gt 268 F 131 C sterilize temperature gt 3 minutes exposure gt 15 min dry time 5 min equalize 15 min test 250 F 121 C Liquid Cycle 1 total For sterilizing liquids in vented or open 1000 mL 34 fluid oz or smaller containers Important Liquid cycles are not intended for sterilization of liquids used in direct contact with patients gt 250 F 121 C sterilize temperature gt 45 minutes exposure gt Dry time Not applicable Note Selection of time and temperatures other than factory recommendations require operator verification of the cycle efficacy Factory default cycles were validated to ANSI AAMI ST8 CYCLE PROGRESSION e Gravity Wrapped Goods Pressure pulse conditioning a Conditioning steam flows in
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