Getinge 433/533HC-E Series Sterilizers

Description

Getinge 433/533HC-E Series Sterilizers Features

Featuring the new AVANTI 8.4″ touchscreen display making it easier than ever to custom name cycles for fast, accurate identification. The 433HC-E and 533HC-E Series offer cycles employing either gravity/downward displacement or pressure/vacuum pulsing. The sterilizers offer up to 24 cycles in two easy steps for applications including wrapped and unwrapped porous and non-porous hard goods, utensils, gowns or towel packs and liquids in self-venting or unsealed containers.

• Optimized for OR/Point-of-use Sterile Processing, Central Sterile Processing (CSSD) and surgery centers
• Avanti touch panel control interface
• Multiple shelf adjustments for larger loads
• USB port standard for downloading back-up cycle performance
• Multiple shelf adjustments for larger loads

Getinge 433/533HC-E Series Sterilizers Specifications

Chamber Sizes

132°C and 135°C Validated Cycles

Medical devices are becoming more complex and now the manufacturer’s written instructions are becoming more differentiated. The 433/533HC-E Series Steam Sterilizers are validated with pre-vacuum and gravity sterilization cycles at 132°C (270°F) and 135°C (275°F). Preprogrammed cycles include gravity cycles and pre-vacuum cycles for immediate-use steam sterilization (IUSS). This saves you time programming custom cycles and self-validating sterilization efficacy.*

*Deviation from pre-programmed cycle parameters requires user validation

FACTORY DEFAULT CYCLES – 24 Total Cycles

275°F (135°C) Prevac-1 Cycle (3 total)

• For sterilizing double wrapped instrument trays up to 25 Lb. (11.3 kg) per tray – or fabric packs.
  • 275°F (135°C) sterilize temperature
  • 3 minutes exposure
  • 16 minutes dry time

275°F (135°C) Prevac-2 Cycle (2 total)

• For sterilizing a single, wrapped instrument; wrapped instrument tray up to 25 Lb. per tray – or fabric packs.
  • 275°F (135°C) sterilize temperature
  • 3 minutes of exposure
  • 3 minutes dry time

275°F (135°C) Prevac-3 Cycle (1 total)

• For sterilizing a single, unwrapped porous or non-porous instrument; or unwrapped porous and non-porous instruments in trays up to 25 Lb. per tray.
  • 275°F (135°C) sterilize temperature
  • 3 minutes exposure
  • zero minutes dry time

270°F (132°C) Prevac-4 Cycle (1 total)

• For sterilizing double wrapped instrument trays up to 25 Lb. (11.3 kg) per tray – or fabric packs.
  • 270°F (132°C) sterilize temperature
  • 4 minutes of exposure
  • 16 minutes dry time

270°F (132°C) Prevac-5 Cycle (1 total)

• For sterilizing fabric packs.
  • 270°F (132°C) sterilize temperature
  • 4 minutes of exposure
  • 3 minutes dry time

250°F (121°C) Gravity-1 Cycle (3 total)

• For sterilizing double wrapped instrument trays up to 25 Lb. (11.3 kg) per tray – or fabric packs.
  • 250°F (121°C) sterilize temperature
  • 30 minutes of exposure
  • 45 minutes dry time

275°F (135°C) Gravity-2 Cycle (3 total)

• For sterilizing double wrapped instrument trays up to 25 Lb. (11.3 kg) per tray – or fabric packs.
  • 275°F (135°C) sterilize temperature
  • 10 minutes of exposure
  • 45 minutes dry time

275°F (135°C) Gravity IUSS-3 Cycle* (4 total)

• For sterilizing single unwrapped, non-porous instrument; or unwrapped non-porous instrument trays, up to 25 Lb. (11.3 kg) per tray.
  • 275°F (135°C) sterilize temperature
  • 3 minutes of exposure
  • 30 seconds dry time

275°F (135°C) Gravity IUSS-10 Cycle* (2 total)

• For sterilizing unwrapped porous or non-porous single instrument; or unwrapped porous or non-porous instrument trays, up to 25 Lb. (11.3 kg) per tray.
  • 275°F (135°C) sterilize temperature
  • 10 minutes of exposure
  • 30 seconds dry time

Note: Refer to AAMI ST79 guidance for Immediate-Use Steam Sterilization (IUSS). Sterilization by the unwrapped method (IUSS) with little or no dry time is efficacious when used in compliance with validated written instructions provided by the device manufacturers, the sterilization equipment manufacturer, the container manufacturer (if applicable) and when done in accordance with professional guidelines. Implantable devices should not be sterilized by the unwrapped method.

250°F (121°C) Liquid1 Cycle** (1 total):

• For sterilizing liquids in a vented or open 1000 mL (34 fluid oz.) or smaller containers. Important: Liquid cycles are not intended for sterilization of liquids used for direct patient contact.
  • 250°F (121°C) sterilize temperature
  • 30 minutes of exposure
  • Dry time: Not applicable

250°F (121°C) Liquid2 Cycle** (1 total):

• For sterilizing liquids in a vented or open 1000 mL (34 fluid oz.) or smaller containers. Important: Liquid cycles are not intended for sterilization of liquids used for direct patient contact.
  • 250°F (121°C) sterilize temperature
  • 45 minutes of exposure
  • Dry time: Not applicable

273°F (134°C) Vac Bowie & Dick test cycle (1 total):

• For conducting B-D tests of pre-vacuum sterilizer using a validated test pack.
  • 273°F (134°C) sterilize temperature
  • 3 minutes & 30 seconds of exposure
  • zero minutes dry time

268°F (131°C) Vacuum Leak Test (1 total):

• For testing the vacuum integrity of the sterilizer’s piping. Note: Vacuum leak test parameters are not adjustable.
  • 268°F (131°C) sterilize temperature
  • 3 minutes of exposure
  • 15 min dry time; 5 min equalize; 15 min test

Note: Selection of time and temperatures other than factory recommendations require operator verification of the cycle efficacy.

* Steam sterilization by the unwrapped (IUSS) method is employed when immediacy does not permit the use of the preferable, wrapped sterilization procedure. Implantable devices should NOT be sterilized by the unwrapped method.

** Liquid cycles are not intended for sterilization of liquids used in direct contact with patients.

CYCLE PROGRESSION

Gravity/Wrapped Goods (Pressure pulse conditioning)

1. Conditioning—steam flows into the chamber for a time period, followed by a series of positive pressure pulses to remove chamber air.
2. Heat-Up—to the selected temperature.
3. Exposure—selected chamber temperature is attained and timed.
4. Exhaust—chamber vented to atmospheric pressure.
5. Dry—filtered air is drawn through the chamber for the duration of time selected. (Either Gravity or Vacuum Dry is selectable; Vacuum Dry is recommended)
6. Cycle Complete—signaled by a tone, light and display a message on the Avanti touch screen.

Pre-vacuum/Wrapped Goods (Vacuum/pressure pulsing conditioning)

1. Conditioning—steam flows into the chamber for a time period, followed by a series of pressure/vacuum pulses to remove chamber air.
2. Heat-Up—to the selected temperature.
3. Exposure—selected chamber temperature is attained and timed.
4. Exhaust—chamber vented to below atmospheric pressure.
5. 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.
6. Cycle Complete—signaled by a tone, light and display message on the Avanti touch screen.

Pre-vacuum/Unwrapped Goods (Vacuum/pressure pulsing conditioning)

1. Conditioning—steam flows into the chamber for a time period, followed by a series of pressure/vacuum pulses to remove chamber air.
2. Heat-Up—to the selected temperature.
3. Exposure—selected chamber temperature is attained and timed.
4. Exhaust—chamber vented to below atmospheric pressure.
5. Dry—typically, not required for the unwrapped vacuum cycle.
6. Cycle Complete—signaled by a tone, light and display a message on the Avanti touch screen.

Gravity/Unwrapped Goods (3 minutes for nonporous items or 10 minutes for porous items)

1. Conditioning—steam flows into the chamber for a time period to remove air. The 10-minute Flash cycle for porous items has a series of positive pulses for dynamic air removal.
2. Heat-Up—to the selected temperature.
3. Exposure—selected chamber temperature is attained and timed.
4. Exhaust—chamber vented to atmospheric pressure.
5. Dry—filtered air is drawn through the chamber for the duration of time selected.
6. Cycle Complete—signaled by a tone, light and display a message on the Avanti touch screen.

Liquids

1. Conditioning—steam flows into the chamber for a time period to remove air.
2. Heat-Up—to the selected temperature.
3. Exposure—selected chamber temperature is attained and timed.
4. Exhaust—an adjustable linear exhaust.
5. Cycle Complete—tone, light and display message signals.

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 1.44°F (0.8°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 (PI).
• 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.

CONTROL SYSTEM

Intuitive Touchscreen Control Streamlines Operations

The new, large 8.4” AVANTI SVGA color touch screen display makes on-screen navigation, cycle selection and modifications to cycle parameters easier than ever. Customize your sterilization cycles after names of surgeons or procedures for quick, accurate identification. You now have the ability to program up to 18 different pre-vacuum cycles for increasing numbers of IFU’s with slightly different parameters.

The operator panel is mounted above the door and provides the following features:

• Getinge Sterilizers employ the PACS 3500 modular PLC control system (CPU) to monitor and control all sterilizer operations and functions.

Control Interface

• The AVANTI user interface panel is a durable 8.4 inch diagonal SVGA color touch screen display.
• All user accessible control functions can be changed with appropriate password using the touch screen interface panel.
• Password protected supervisor and service access security
• The control system is factory programmed with standard sterilizing cycles.
• Tap to display cycle list and select cycles
• Each cycle is adjustable to meet specific reprocessing requirements.
• Quick, on-screen editing of cycle parameters
• Text messages in lieu of codes and symbols
• Audible and visual feedback
• Temperature can be set, controlled and displayed in degrees Celsius or Fahrenheit.
• Pressure is preset to be controlled and displayed in PSI.
• Variety of different process displays, including circle graph, plot graph, bar graph or a details list

Control Board

• NetCom Ethernet connection for remote monitoring of processes
• An RS 232 port is provided for serial communications for central data collection or remote service analysis and is ready for TDOC® connection.
• T-DOC instrument tracking interface
• USB printer interface
• A key lock is provided to insure all door power is disconnected when working in the chamber.

Panel Mounted Cycle Performance Documentation

• Thermal-paper cycle printer with take-up spool.
• Jacket and Chamber Pressure Gauges
• USB flash drive slot for back-up cycle records.

The Getinge 433-533HC-E-Series sterilizer provides three standard means for Cycle Documentation:

1. Paper Cycle Printer
2. USB Flash Memory Output
3. NetCOM Ethernet Connection

1. Cycle Printer

• Documents cycle performance using special thermal paper for a permanent record (100-year storage warranty).
• Thermal printing allows for quiet operation.
• The printer is located in the control panel and documents the following on a 200-dpi dot matrix printer with 1.88″ (47.6mm) wide paper:
  • Process start time and date, sterilizer name and number, daily cycle number and total cycle count
  • Cycle selected with time and temperature, with other adjustable parameters identified
  • Cycle phase transition points, temperature, pressure and total cycle time
  • Process fault information messages with the time of occurrence
  • Parameter Check provided a calculated, numeric process lethality
  • Summary verification of time at the selected temperature (min/max exposure values)
  • 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”.

2. USB flash drive

• For backup/informational purposes, the same cycle performance data is also automatically sent to a USB flash drive port in the front of the control panel.
• 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 compatible printer in lieu of the USB flash drive.

3. NetCOM Communications Card

• 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):
  • T-DOC data logging storage and printing
  • T-DOC instrument tracking and asset management
• Note: Separate equipment and setup required, including network Ethernet cable drop by the customer for each sterilizer. Internet access may be required.
  Contact Your Regional Representative for details.

AVANTI User Interface Features

The AVANTI touch screen serves as the user’s command and control center. The screen is divided into specific sections to display cycle selection, operation and process performance information in a consistent manner.

Four process display screens are available to show important cycle information in different formats for ease of recognition.

The Optional Screens Are:

1. Bar Graph
2. Circle Graph
3. Plot Graph
4. Details Display

1. 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.

Lower Button Field

• Across the bottom and displays the application buttons that are used to give commands.
• Cycle Select:
  • Tap to access and select from 24 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 a cycle.

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 noncritical system messages are displayed in the central area.

2. 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.

Middle Display Field

• 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 are viewed and can be changed with the proper password clearance.
• Simply “tap” the value on the screen when in “standby” and follow the intuitive displays to 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.

3. 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.

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:
  • System Menu
  • Process Screen
  • Documentation – Password Required
  • Alarm History

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 set up the following:
  • Refer to the MENU tree in Appendix C of the User Manual
  • Access the system “About” section to identify the model and software version number
  • Add new users with passwords
  • Adjust system menu for setting the calendar
  • Select language, date format, and temperature and pressure measurement
  • Re-order and/or re-name cycles
  • Edit cycle parameters
  • Activate the utilities control feature to shut-off water and steam to the sterilizer to conserve energy
  • Print the last cycle
  • Note: Adjustment of time and temperature parameters requires user validation of the cycle efficacy. Factory recommended cycles are validated to ANSI/AAMI ST8.

4. 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.

NOTE: A screen saver extends the life of the backlit LCD and saves energy. Touching any key illuminates and reactivates the display.

CONFIGURATION OPTIONS

• Recessed or Freestanding With Cabinet Package
• Single or Double-Door for Pass-Thru Operations
• Water-Ejector Vacuum or Vacuum Pump
• Stainless Steel Piping to Jacket and Chamber

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, door, and jacket material are constructed of 316L 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 (310 kPa).
• The gasket ring holds a continuous, one-piece silicone gasket, 0.63” (16 mm) in diameter.
• The body assembly is thermally insulated with 1.5” fiberglass insulation and is double thick between the 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.
• When rack and shelves are supplied, shelf adjustments will be approximately every 2.5” (63.5 mm).
• Individual rack supports and shelves are easy to remove for cleaning.

VERTI-GLIDE DOOR

• The vertical sliding door is counterbalanced for ease of operation.
• When open, it is totally out of the way, allowing safe and complete access to the chamber.
• Opening or closing the manual door requires only gentle upward or downward hand pressure.

Optional Power Door

• Operated by a footswitch, and the door will stop automatically if an obstruction is encountered.
• If the footswitch is actuated while the door is opening or closing, the direction will be reversed.
• The Power Door can be opened or closed manually.

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 sealed position.
• The door is insulated with fiberglass insulation and covered with a stainless steel panel.

PANELING

• The front paneling is constructed of nominal 0.050” (1.27 mm) No.3 brushed finished stainless steel and is hinged for easy access to components, the manual gasket retract valve and, if specified, the electric steam boiler.
• The trim panels are built-in to fit within a recessed wall or optional cabinet.
• When specified, the cabinet model will be made of the same material.

OPTIONAL – INTEGRAL STEAM BOILER

• The carbon steel or 304L stainless steel steam boiler will have a 30 kW capacity at standard 3-phase voltages and include an automatic fill valve to ensure the correct water
  level at all times.
• The unit includes ASME CSD-1 low water cut-off safety device.
• The sterilizer control on/off switch controls the boiler control power (115V).
• The steam boiler is automatically controlled to generate and maintain a supply of steam to the sterilizer at a minimum of 40 psig (3.72 Bar).
• An automatic feed water pump is provided as standard.

STANDARD SAFETY FEATURES

• Steam Interlock Door Switch
  • Prevents steam from entering the chamber when the door is not sealed.
• Steam Safety Valve(s)
  • There are Steam Safety Relief valve(s) which ensures that the pressure in the chamber and or jacket do not over-pressurize.
• Door Obstruction Shut-off
  • If the automatic door encounters an obstacle, a safety clutch stops the door movement and after a short time-out, the motor is shut down.
• Analog Chamber Gauges
  • Two needle-style gauges give real-time pressure readings in the chamber and jacket even in the event of micro-computer control system outage.
• Parameter Check
  • The control system verifies all user-programmed cycle parameters against time/temperature sterility assurance level recommendations.
  • A warning appears if the user’s attempt to program a cycle beyond recommended parameters.
• Supervisor Password
  • A supervisor password is required to change cycle names or parameters.
• Abort Alert
  • Aborted cycles result in a warning message that requires user intervention before the chamber can be reopened.
• Gasket Retract Valve
  • In the event, emergency access to the chamber becomes necessary the gasket may be retracted manually.
• 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.
• Heat Guards and Insulation
  • Insulation and heat guards are built-in on all surfaces where users routinely come into contact, particularly near the door and chamber openings.
• Water Alarm
  • The chamber drain is continuously monitored for the presence of water during a cycle.
  • High water levels in the drain that cannot be corrected automatically result in an audible alert.
• Temperature of the Discharge Water
  • Controlled by RTD to be less than 140°F (60°C).
  • This device also conserves water by cooling the drain effluent only when needed.

Automatic Utilities Control Feature

• Provides a seven-day timer for programmed startup and shutdown of the sterilizer.
• When activated, this program shuts OFF water and steam valves to the sterilizer (including the optional steam boiler) to conserve energy.
• Cycles running beyond the programmed shutoff time will be completed.

AVAILIBLE ACCESSORIES

OPTIONS

• Optional 30kW steam boiler can replace house steam (3 pH power)
• Stainless steel boiler option for RO water clean system applications
• Optional mechanical vacuum pump in lieu of water-ejector
  • Better cycle performance
  • Lower water consumption
• Optional Water Saver Package for Vacuum Ejector Models only
  • 115V
  • 230V
• Optional 115V Water Chiller Unit for Water Saver
• Optional House chilled water COIL in lieu of electric Water Chiller
• Optional Uninterrupted Power Supply (UPS).
  • Provides control power for up to 30 minutes to complete a cycle in process. (Vacuum ejector models only)

LOADING ACCESSORIES

• 500 Series “SMART” Fixed Height Transfer Trolley and Load Car
• Interior Rack With Extendable Shelves
• Removable Load Car With Transport Trolley
• Instrument Basket
• Peel Pouch Sterilization Rack

STERILITY ASSURANCE ACCESSORIES

• BIOSIGN Steam-24 Biological Indicator (BI)
• BIOSIGN SSI Test Pack
• Getinge Assure AccuFast Biological Test Pack
• CHEMISIX Family of Chemical Sterilization Monitors
• Steam Sterilization Integrators
• Assure S.M.A.R.T Green Bowie & Dick Test Pack

ATP CONTAMINATION MONITORING SYSTEM

• The Getinge Assure SafeStep Contamination Monitoring System verifies the cleanliness of surfaces, endoscopes and cannulated instruments in just 15 seconds.
• By detecting ATP (adenosine triphosphate) – an indicator of residual contamination.
• SafeStep gives you the testing power to minimize HAIs and optimize patient and staff safety.

INSTALLATION, SERVICE, AND SUPPORT

• National Installation at all Levels
• Complete product IQ, OQ and PQ services.
• Service contracts and life cycle technical support.
• Performance optimization for maximum uptime performance.

ENVIRONMENTAL IMPACT

• Getinge steam sterilizers are designed and constructed with our environment in mind.
• To aid in the conservation of natural resources, and in recognition of prevailing Environmental Policies, in particular, ISO 14001, Getinge steam sterilizers are more than 90% (by weight) recyclable.
• Under normal operation, Getinge steam sterilizers produce no harmful byproducts.
• The Getinge steam sterilization process, in and of itself produces nothing more dangerous than hot drain water.

STANDARDS

The sterilizer shall comply with or meet the requirements of:

• Compliant with AAMI ST8:2008 for tray sets up to 25 pounds each
• Validated with programs to sterilize at either 132°C or 135°C
• 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 2010
• Cycle Performance Validated to ANSI/AAMI ST8:2008
• CSA 2314.7-03 (R2008)