AMSCO 400 Small Sterilizer

AMSCO® 400 Series Small Steam Sterilizers are engineered to be fully compliant with current steam sterilization standards. The 20 x 20 sterilizer is validated to accommodate a maximum of three 25-lb sets (up to 75 lbs) per load, and the 16-inch models can sterilize two 25-lb sets (up to 50 lbs per cycle), per AAMI guidance for processing weights. They also accommodate solo sets and larger bariatric and orthopedic devices. An optional Steam Flush Pressure Pulse (SFPP) configuration adds this cycle to your autoclave, eliminating the need for Bowie-Dick testing which reduces operating costs. Also, the AMSCO 400 Series Small Steam Sterilizers prevacuum and steam-flush-pressure-pulse (SFPP) cycles have been validated, per AAMI recommendation, for porous items. Validated “immediate-use” prevacuum and gravity cycles are available, replacing “flash” terminology, and cycles can be customized and named by the user. AMSCO 400 Series software reduces steam and water usage per pound of instruments processed.

Description

AMSCO 400 Small Sterilizer Features

The AMSCO 400 Small Sterilizer is engineered to be fully compliant with current steam sterilization standards.

  • Meets current AAMI/AORN guidelines
  • Process up to 3 – 25lb trays
  • Validated 4 + 1 pre-vacuum immediate use cycle
  • Touch-screen with 30-line x 40-character display area
  • Help screens for programming and troubleshooting alarm conditions
  • Improves staff productivity with the highly visible cycle phase and time remaining display
  • Customizable cycle names
  • Fully programmable cycles to help meet instrument manufacturer processing recommendations
  • Ink-on-paper impact printer
  • Service reprogrammable flash ROM memory
  • Automatic check of control program and cycle data maintains process integrity
  • Use 60% less water by choosing the available electric vacuum pump
  • Helps achieve your LEED certification goals
  • Sensors that minimize cooling water needs
  • Programmable auto-utilities shutdown
  • Fully insulated to minimize heat loss to the surrounding environment
  • Minimize excess condensation with fully jacketed construction that envelopes the entire chamber in the steam
  • Steam activated gasket helps prevent air from entering the chamber and never requires lubrication
  • Steam flush pressure pulse (SFPP) cycle can eliminate the need to perform daily air removal testing
  • Hands-free foot pedal aids in the efficient handling of sets
  • Vertical sliding door with hands-free loading and unloading capability.
  • Non-lubricated, steam-activated door seal

UTILITIES CONSERVATION FEATURES

Resistance Temperature Detectors (RTD)

  • Installed for sterilizer temperature control.
  • The chamber drain line RTD senses and controls temperature variations within the sterilizer chamber.
  • A jacket RTD provides temperature control within the jacket space.
  • These RTD signals converted into electrical impulses, provide accurate control inputs and readouts throughout the entire cycle and minimizes utility usage.

Electronic water saving control includes a condenser RTD

  • Controls the amount of water used in condensing the exhausted chamber steam.
  • Control software minimizes the amount of water used to cool condensate.

Automatic Utilities Startup/Shutdown

  • Programmed to activate at the end of any designated cycle or time of day.
  • When activated, the control system automatically shuts off all utility valves, conserving steam and water usage.
  • Sterilizer utilities can be restarted either by programmed time or manual operation.
  • A different shutdown and restart time can be programmed for each day.

Insulation

  • One-inch thick, asbestos-free spin-glass (rated at 500°F [260°C] continuous) encompasses the exterior of the sterilizer vessel.
  • Sealed in an oil and water-resistant outer jacket.

Vacuum System

  • Water ejector reduces chamber pressure during the pre-vacuum and post-drying phases.
  • Air is drawn from the chamber through the vacuum system.
  • Following the dry phase, the chamber vacuum is relieved to atmospheric pressure by admitting air through a bacteria-retentive filter.

Optional Vacuum Pump

  • Ordered in place of the standard water ejector.
  • The vacuum pump provides equivalent performance but reduces cooling water consumption by up to 60%, helping facilities to conform with Leadership in Energy
    and Environmental Design (LEED) requirements.

AMSCO 400 Small Sterilizer Specifications

AMSCO 400 Small Sterilizer Interior Chamber Dimensions

  • 16 x 16″ Sterilizers – Chamber Clearance
    • 12″ (304 mm) for the top shelf
    • 14″ (357 mm) for the bottom shelf
  • 20 x 20″ Sterilizers – Chamber Clearance
    • 18″ (457 mm) for intermediate shelves
    • 15″ (381 mm) for the bottom shelf

PROCESSING CYCLES

All cycles validated to AAMI standard ST8:2008.

Pre-vacuum Sterilizer Models feature the following cycles:

Immediate Use, Prevac Cycle (4-minute exposure):

  • Cycle type is for sterilizing porous and non-porous loads.
  • Examples – A single unwrapped instrument tray or up to a full a load of unwrapped instrument trays, each with a maximum weight of 25 lb (11 kg).
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 4 minutes
  • Dry time:
    • 1 minute

NOTE: Items sterilized for immediate use must be used within the shortest possible time after removal from the sterilizer and must be taken to the sterile field using aseptic transfer protocols.

  • A sterilized item intended for immediate use must not be stored.
  • An item sterilized for immediate use cannot be held for use on a future case.
  • The Prevac immediate use cycle is the preferred immediate use cycle.
  • The Gravity immediate use cycle is only safe for simple instruments that contain no hinges or other features that could trap air.
  • Always refer to instrument manufacturer’s instructions for use to determine processing requirements.

Prevac Cycle (4-minute exposure):

  • Cycle type is for sterilizing porous and non-porous loads.
  • Example – Wrapped 25 lb (11 kg) instrument tray(s) or fabric packs.
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 4 minutes
  • Dry time:
    • 30 minutes (a full load of instruments trays)
    • 20 minutes (a full load of fabric packs)
    • 5 minutes (Customer option, for a single fabric pack)

Prevac Cycle (3-minute exposure):

  • This cycle is for sterilizing porous and non-porous loads.
  • Example – Wrapped 25 lb (11 kg) instrument trays.
  • Sterilize exposure temperature:
    • 275°F (135°C)
  • Sterilize exposure time:
    • 3 minutes
  • Dry time:
    • 30 minutes

Immediate Use, Gravity Cycle (3-minute or 10-minute exposure):

  • Cycle type is for sterilizing non-porous loads.
  • Example – A single unwrapped instrument tray or up to a full load of unwrapped instrument trays, each with a maximum weight of 25 lb (11 kg).
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 10 minutes
    • 3 minutes
  • Dry time:
    • 1 minute
  • See Note on the first listed cycle regarding immediate use.

SFPP Sterilizer Models also feature the following cycles (in addition to those found on Pre-vacuum models):

SFPP Cycle (4-minute exposure):

  • This cycle is for sterilizing porous and non-porous loads.
  • Example – A wrapped 25 lb (11 kg) instrument tray.
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 4 minutes
  • Dry time:
    • 30 minutes (a full load of instruments trays)
    • 20 minutes (a full load of fabric packs)
    • 5 minutes (Customer option, for a single fabric pack)

SFPP Cycle (3-minute exposure):

  • This cycle is for sterilizing porous and non-porous loads.
  • Example – A wrapped 25 lb (11 kg) instrument tray.
  • Sterilize exposure temperature:
    • 275°F (135°C)
  • Sterilize exposure time:
    • 3 minutes
  • Dry time:
    • 30 minutes

OPTIONAL CYCLES:

The following cycles are available on Prevac and SFPP sterilizers, and can be made accessible for use by the departmental supervisor:

Gravity Cycles:

  • Full Load, Non-porous Instrument Trays
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 15 minutes
  • Dry time:
    • 30 minutes
  • Full Load, Non-porous Instrument Trays
  • Sterilize exposure temperature:
    • 250°F (121°C)
  • Sterilize exposure time:
    • 30 minutes
  • Dry time:
    • 30 minutes
  • Full Load, Fabric Packs.
  • Sterilize exposure temperature:
    • 270°F (132°C)
  • Sterilize exposure time:
    • 25 minutes
  • Dry time:
    • 15 minutes
  • Full Load, Fabric Packs.
  • Sterilize exposure temperature:
    • 250°F (121°C)
  • Sterilize exposure time:
    • 30 minutes
  • Dry time:
    • 15 minutes

Liquid Cycle:

This cycle is used for sterilizing liquids in borosilicate containers with vented closures. The 16″ sterilizer can process a maximum load of fifteen 1000 mL containers. The 20″ sterilizer can process a maximum load of thirty two 1000 mL containers.

  • Sterilize temperature:
    • 250°F (121°C)
  • Factory programmed sterilize time:
    • 45 minutes
  • Dry time:
    • Not Applicable
  • Important: The liquid cycle is for non-patient contact use only.

PREVACUUM TESTING CYCLES

Vacuum Leak Test:

  • This cycle is used for testing the vacuum integrity of sterilizer piping.
  • The sterilizer chamber must be empty while running this test cycle.
  • Temperature:
    • 270°F (132°C)
  • All timing is preprogrammed and cannot be adjusted.
  • This cycle is validated to AAMI standard ST8:2008.

A Preprogrammed Bowie-Dick Test Cycle

  • Used to test for adequate air removal from the sterilizer chamber.
  • The recommended load is a Dart® testing apparatus from STERIS or a properly prepared Bowie-Dick test pack.
  • Preprogrammed cycle parameters cannot be adjusted by the user.
  • Sterilize Exposure Temperature:
    • 270°F (132°C)
  • Sterilize Exposure Time:
    • 3-1/2 minutes
  • Dry Time:
    • 1 minute
  • This cycle is validated to AAMI standard ST8:2008

CONTROL SYSTEM

Design Features

The Control System

  • Monitors and controls all sterilizer operations and functions.
  • The control system is factory-programmed with standard sterilizing cycles.
  • Each cycle is adjustable, and cycle names are user-programmable, to meet specific processing requirements.
  • Cycle parameters cannot be adjusted to less than preset, validated settings.
  • All control configuring is performed through the touch-screen display.

Important: Always refer to the instrument manufacturer’s instructions for use to determine processing requirements.

Cycle Values and Operating Features

  • Adjustable and Verifiable prior to cycle operation.
  • Once the cycle is started, cycles and cycle values cannot be changed until the cycle is complete.
  • On completion of a cycle, timers reset to the previously selected values, eliminating the need to reset values between repeated cycles.
  • If chamber temperature drops below setpoint during the exposure phase the timer stops.
  • It automatically resets once the normal operating temperature is reached.

Critical Control System Components

  • Housed within a compartment to protect the components from moisture and the heat generated during sterilization.
  • A cooling fan with filter maintains airflow within the compartment, keeping components cool.

Operator Interface Control Panel

  • Consisting of a Touch-screen and Impact printer.
  • Located on the operating end (OE – loading end or nonsterile end) of the sterilizer.
  • If the sterilizer is equipped with double doors, an additional touch-screen (but no printer) is provided on the sterilizer non-operating end (unloading or sterile).

Touch-Screen Features

  • 30-line x 40-character graphics display.
  • The control touch-screen, from which all sterilizer functions are controlled, features a wide viewing angle and high-visibility back-lighting.
  • The display indicates any abnormal conditions that may exist, either in or out of cycle.
  • Displayed messages are complete phrases with no codes to be cross-referenced.

Ink-On-Paper Impact Printer

  • Located near touch-screen.
  • provides an easy-to-read printed record of all pertinent cycle data.
  • Data is automatically printed at the beginning and end of each cycle and at transition points during the cycle.
  • Printer take-up spool stores an entire roll of paper, providing cycle records which can be saved for future reference.
  • Three paper tape rolls are furnished with each unit.

Non-Operating End (NOE) Control Panel

  • Equipped on double-door sterilizers only.
  • Includes a touch-screen similar to the operating end screen, but no printer.
  • Preprogrammed cycles can be started from the NOE control panel.
  • Display concurrently shows the same information as the operating end screen display.

Cycle Configuration

  • Performed by accessing the Change Values Menu through the operating end touch-screen.

In addition to the adjustment of cycle values, the following operating parameters can also be changed through the Change Values Menu:

  • Time Display and Printout Units
    • Standard AM/PM or 24-hour.
  • Access Code
    • Accessing Change Values menu causes the display to request the entry of an access code.
    • If an access code is not properly entered, the display returns to the menu screen, denying user access to the sterilizer programming.
    • Supervisors can allow operators to change the chosen cycle and parameters, or lock them out from making any changes.
  • Audible Signals
    • Adjustable.
    • Sounds made when touching the screen and for end-of-cycle signals can be adjusted to one of four sound levels (off, low, medium or high) as required for the operating environment.
    • The alarm signal can be adjusted to low, medium or high; but cannot be turned off.
  • Print Format
    • Allows selection of either a full or condensed printout of the cycle information during processing.
  • Temperature Display and Printout Units
    • Fahrenheit (°F) or Celsius (°C).
    • Temperature is set, displayed, controlled and printed to the nearest 0.1°.
    • Recalibration is not required when changing temperature units from °F to °C and vice versa.
  • Pressure/Vacuum Display and Printout Units
    • psig/In Hg, millibar or psia.
    • Recalibration is not required when changing pressure units.
  • Utility Control
    • This parameter permits the operator to program the sterilizer to automatically shut off its steam and water at the end of the workday, to conserve utilities.
    • It also allows control for shut down and power-up of an integral steam generator.
  • Languages
    • This parameter can be used to select English, French or Spanish as the default for displays and printouts.
    • The sterilizer can also be set to allow quick changes between available languages.
  • Machine Number
    • This parameter assigns a six-character, alphanumeric code to the sterilizer.
    • This code appears in the heading of all printouts.
  • Automatic Duplicate Print
    • The sterilizer can be set to automatically furnish a duplicate printout of each cycle at the end of the cycle.
    • First-line reads “DUPLICATE PRINT.”

Technical Data

  • Control system consists of a microcomputer control board and peripheral function circuit boards located within the control board housing behind the front cabinet service panel above the chamber.
  • A memory backup system maintains cycle settings indefinitely and current cycle information for approximately five days.
  • If a power failure occurs during a cycle, the battery backup system ensures that cycle memory is retained and proper cycle completion occurs once power is restored.
  • When power is lost, the cycle is held in phase until power is restored, exceeding the minimum government specification of one minute.
  • Once power returns, the event is recorded on the printout and the cycle automatically resumes or restarts, depending on what phase the cycle was in at the time of
    power loss.
  • If necessary, the operator can manually abort the cycle.

SAFETY FEATURES

  • Control senses when the door is closed and sealed, preventing cycle start until a limit switch signal is received.
  • If control loses appropriate signal during a cycle, the alarm activates, cycle aborts and chamber safely vents with a controlled exhaust.
  • Chamber Float Switch activates an alarm, aborts the cycle and safely vents chamber with a controlled exhaust if excessive water is detected in the vessel chamber.
  • Pressure Relief Valve limits the amount of pressure buildup so that the rated pressure of the vessel is not exceeded.

CONSTRUCTION

Shell Assembly

  • Two fabricated Type 316L stainless-steel shells welded one within the other, form the sterilizer vessel.
  • Type 316L stainless-steel end frame(s) is welded to door end.
  • On single door units, back of the chamber is fitted with welded, 316L stainless-steel formed the head.
  • Sterilizer vessel is ASME rated at 50 psig and insulated.
  • Vessel (20 x 20″ units only) includes one 1.0″-NPT welded chamber bushing for Customer use.
  • Steam-supply opening inside the chamber is shielded by a Type 316L stainless-steel baffle.

Chamber Door(s)

  • The door is constructed of a single formed piece of Type 316L stainless steel.
  • During cycle operation, the door is sealed by a steam-activated door seal.
  • The door seal is constructed of a special long-life rubber compound.
  • When the sterilizer cycle is complete, the seal retracts under vacuum into a machined groove in the sterilizer end frame.
  • Door seal can be manually retracted to open the door and remove critical load in an emergency situation if a loss of vacuum or loss of power occurs.
  • The door is suspended by cables attached to a counterweight.
  • Chamber door is opened (lowered) and closed (raised) by pressing a foot pedal located on the same end as the door being operated.
  • In case of a power or mechanical failure, the door can be operated manually.
  • A long-life proximity switch is used by the control to determine if the door is closed.
  • An additional seal pressure switch prevents inadvertent cycle initiation if the door is not sealed.
  • The door assembly is equipped with a mechanical locking mechanism that ensures the door cannot be opened as long as the seal is intact and energized and more than 2.0 psi pressure is in the chamber.
  • The sterilizer door opening is fitted with a textured thermoplastic bezel.
  • This bezel insulates the operator from the chamber end ring, lessening the chance of accidental contact with a hot metal surface.

Chamber Drain System

  • The drain system is designed to prevent pollutants from entering into the water-supply system and sterilizer.
  • The automatic condensing system converts chamber steam to condensate and disposes of condensate to waste.
  • Cooling water flow is regulated by the waste line RTD to minimize water usage.
  • Water supply shutoff valve is located behind the front cabinet service panel under the chamber.

Steam Source

  • Sterilizers are piped, valved and trapped to receive building-supplied steam delivered at 50 to 80 psig dynamic.
  • If building steam source is not available, an electric carbon-steel steam generator may be provided to supply steam to the sterilizer.
  • The steam piping is constructed of brass and includes a shutoff valve, steam strainer, flush system, and a brass pressure regulator.

Piping

All piping connections terminate within the confines of the sterilizer and are accessible from front and side of the sterilizer.

  • Solenoid Valves in the manifold with DIN connectors simplify sterilizer piping and can be serviced individually.
  • Manual Shutoff Valves are pressure rated at 125 psig for saturated steam. Valve handles are low-heat conducting.

MOUNTING ARRANGEMENT

  • Sterilizers are arranged for either freestanding or recessed installation, as specified.
  • Each sterilizer is equipped with a height-adjustable steel floor stand.
  • Sterilizer subframe is equipped with a synthetic rubber gasket to ensure a tight fit between the cabinet panels on freestanding units or between the front cabinet panel and wall partition on recessed units.
  • On freestanding units, stainless-steel side panels and a louvered top panel enclose the sterilizer body and piping.

ACCESSORY

  • Seismic Tie-Down Kit – conforms to California Code of Regulations.

NOTES

  1. The sterilizer is not supplied with a vacuum breaker or backflow preventer and, where required by local codes, installation of such a device in the water line is not provided.
  2. Building service lines (not provided), must supply the specified pressures and flow rates.
  3. Disconnect switches (with OFF position lockout only; not provided) should be installed in electric supply lines near the equipment.
  4. Access to the recessing area from the control end of the sterilizer is recommended.
  5. Clearances shown are minimal for installing and servicing the equipment.
    • If loading car and carriage are to be used with a 20 x 20 x 38″ sterilizer, front clearance should be at least 76″ (1930 mm).
    • This permits complete withdrawal of the loading car from the chamber and allows convenient maneuverability of the transfer assembly to and from the sterilizer.
  6. Floor drain should be provided within confines of sterilizer framework.

UTILITY REQUIREMENTS

AMSCO 400 Small Sterilizer Engineering Data
AMSCO 400 Small Sterilizer Engineering Data

Sterilizer Using Facility Steam

  • Steam
    • 1/2″ NPT, 50 to 80 psig, dynamic, 97 to 100% vapor quality.
  • Drain
    • 1-1/2″ ODT drain terminal.
    • (Floor drain capacity must handle peak water consumption; refer to Engineering Data.)
  • Electrical Controls
    • 120 Volt, 50/60 Hz, 1-phase, 2.0 Amps
    • 220 Volt, 50/60 Hz, 1-phase, 1.5 Amps
  • Sterilizer Feed Water 1″ NPT
    • 30 to 50 psig for water ejector1
    • 20 to 50 psig for vacuum pump.
    • Minimum 40 psig for SFPP sterilizers.
  • NOTE: Backflow prevention (not supplied on the unit) is not provided.

1. Water is used for ejector (creating chamber vacuum), exhaust cooling and cooling the generator drain. Refer to Table 1 for the recommended water quality. Use of feed water within the nominal conditions optimizes equipment performance and helps reduce maintenance.

Sterilizer Equipped with Integral Carbon Steel Steam Generator

Every AMSCO 400 Series Small Steam Sterilizer equipped with an electric steam generator includes an automatic flush and drain package.

Drain

  • 1-1/2″ ODT drain terminal.
  • (Floor drain capacity must handle peak water consumption; refer to Engineering Data.)

Generator Drain

  • 1/2″ ODT

Electrical Controls

Two Configurations

Config. 1

  • 120 Volt
  • 50/60 Hz
  • 1-phase
  • 9.5 Amp1

Config. 2

  • 220 Volt
  • 50/60 Hz
  • 1-phase
  • 5.0 Amp2

Electrical – Integral Steam Generator

Four Configurations

Config. 1

  • 208 Volt
  • 50/60 Hz
  • 3-phase
  • 83.2 Amps

Config. 2

  • 240 Volt
  • 50/60 Hz
  • 3-phase
  • 72.2 Amps2

Config. 3

  • 380/415 Volt
  • 50/60 Hz
  • 3-phase
  • 38/42 Amps3

Config. 4

  • 480 Volt
  • 50/60 Hz
  • 3-phase
  • 37 Amps2

Sterilizer Feed Water – 1.0″ NPT

  • 30 to 50 psi for water ejector.
  • 20 to 50 psi for vacuum pump dynamic.
  • Refer to Table 1 below for water specification guidelines.

AMSCO 400 Small Sterilizer Table 1

Steam Generator Feed Water – 1/2″ NPT

  • 20 to 50 psig dynamic.
  • Refer to Table 2 below for the required water quality.
  • Use of feed water within the nominal conditions optimizes equipment performance and reduces maintenance.

AMSCO 400 Small Sterilizer Table 1

NOTE: Backflow prevention (not supplied on unit) is not provided.

CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH APPLICABLE LOCAL AND NATIONAL CODES AND REGULATIONS.

1. The 120V, 50/60 Hz control is always used with the 208V, 240V, and 480V integral steam generator/vacuum systems.

2. The 220V, 50/60 Hz control is always used with the 380/415V integral steam generator/vacuum system.

STANDARDS

Each sterilizer meets applicable requirements of the following listings and standards, and carries the appropriate symbols:

  • ANSI/UL 61010-1 and CAN/CSA-C22.2 No. 61010-1
    • The standard for Electrical Equipment for Measurement, Control, and Laboratory Use
    • Part 1: General Requirements
  • ANSI/UL 61010A-2-041
    • Standard for Electrical
    • Equipment for Measurement, Control and Laboratory Use
    • Part 2: Particular Requirements for Autoclaves using Steam for the Treatment of Medical Materials and Laboratory Processes
  • ANSI/AAMI-ST8:2008
    • “Hospital Steam Sterilizers” American National Standard
  • ASME Code, Section VIII, Division 1
    • For unfired pressure vessels.
    • The pressure vessel is so stamped; ASME Form U-1 is furnished.
    • Shell and door are constructed to withstand a working pressure of 50 psig (344.7 kPa).
  • ASME Code, Section I, Part PMB
    • For power boilers, if an optional steam generator is supplied.
  • CAN/CSA-C22.2 No. 61010-1