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The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

The Castle® SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris® System 1 peracetic acid sterilization process, with Steris 20 sterilant. The product contains chromatography paper strips that are inoculated with Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 105 per strip. Sterile tubes of Castle Culture Media (modified soybean casein broth) and a transfer clip are included. The materials of construction are equivalent to the Unispore® product. The product is intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.

The Model 733HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

The 733HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a medium sized chamber and has the same control system and offers similar overall features as those on the 400HC/500HC Series Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.

Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids to be used to tienties mappes contact) by means of pressurized steam.

The 400HC/500HC Series Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates an update to the control system that provides additional functionality and ease of use to the end user. It includes a larger color display that will allow the user to choose from the entire list of available cycles. Similar features to those on the Series 100HC include renaming and re-sequencing of sterilization cycles. The full lists of available cycles are provided in Table 1 for vacuum sterilizers (Models 433HC and 533HC) and Table 2 for gravity sterilizers (Models 422HC and 522HC).

Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

The 100HC Steam Sterilizers represent a series of sterilizers intended for use in hospital and health care facilities. The product provides an update to the control system that provides additional functionality and ease of use to the end user that includes the added flexibility to adjust cycle parameters (as on previous sterilizer models), rename, and reassign (re-sequence) the designated sterilization cycles.

The Castle 3000 Surgical Lamp is to be used to provide illumination appropriate for examination, trauma, and surgical procedures.

Getinge/Castle, Inc. 3000 Series surgical lamps are designed to provide the high quality lighting required in an operating room environment. The standard configuration shall be a two lamp head system. Two sizes of lamp head will be offered, a 24" diameter and a 32" diameter. There are four major considerations in the design of the surgical lamp systems: Infra-red and Ultra-violet filtration will exceed the specifications as set forth by IEC 601-2-41. Color Representation, as measured by Color Rendering Index and color temperature, will meet or exceed the specifications of IEC 601-2-41. Light delivery, upon failure of one bulb, will continue to be > 70% intensity . Electromagnetic and Bacteriological Neutrality - The product has been designed, and will be tested, to comply with the electromagnetic compatibility requirements of the European Medical Device Directive. The sealed optical unit, the flat smooth surfaces, and the touch-controls provide for an aseptic interface. The lamp head is designed to provide limited interruption of laminar air flow. The lighting systems are supported by specifically designed, steel and aluminum, load bearing drop tubes, yokes, and counterbalance arms. These assemblies are either covered with chemically resistant plastic, or coated with epoxy resin paint. The structures are mechanically connected at pivot points housing fiber optic connection joints. The lamp heads are able to be positioned in virtually any orientation, with no drift once positioned. The light source is an assembly comprised of eight metal halide light bulbs, a dichroic reflective surface to absorb ultra-violet and infra-red radiation, and fiber optic bundle connection points. Color correction is provided by Light Emitting Diode bundles which are mixed with the feed line. These bundles are controlled through an electronic sensor/comparator loop to provide constant, correct color temperature.

THE PRODUCT WILL BE USED TO ILLUMINATE SURGICAL PROCEDURES WITH COLOR CORRECTED WHITE LIGHT AND HEAT FILTERING (IR). DESIGNED TO ELIMINATE SHADOWS AND ILLUMINATE DEEP CAVITY WOUNDS WITH ADEQUATE PENETRATION. IT IS INTENDED TO BE USED BY SURGEONS AND OTHER MEDICAL CARE PRACTITIONERS IN A SURGICAL SETTING. THERE ARE NO CONTRA-INDICATIONS FOR USE.

The Getinge/Castle OptiView® surgical lights are designed to provide the high quality light required in an operating room setting. There are four major considerations that the lights have been designed for: 1. Shadow Elimination. 144 radial dioptric lenses, disposed equally on the lens glass, are used to broaden the light beam such that a 10 X 20 cm patch of light is produced on the surgical site from each lens. Should one or several of the lenses become obstructed by the surgeon or from equipment, a constant quantity of light is subtracted from each point of the light field. This virtually eliminates shadows and provides for optimum visibility. 2. Optimal Depth of Field. A central toric lens and conic mirror is used to produce very broad beams whose intersection are not points but are volumes. In some cases the volume can measure up to 70 cm in height and 20 cm across the center. The design also allows the volume of light to be moved in the axis of the beam, this is called variable focusing. 3. Heat Elimination and High Color Rendition. Through the use of a special type of glass, the emitted light is corrected for color (towards the model for broadband sunlight) and filtered for infrared. This eliminates the thermal effect of the beam and allows a color rendition index of Ra = 95 or greater. 4. Electromagnetic and Bacteriologic Neutrality. The product have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls provide for an extremely aseptic environment. The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed to comply with international safety standards such as: Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Electromagnetic Compatibility Directive (EMC) 89/336/CEE, Decree No. 95-587 Medical Device Directive (MDD) 93/42/CEE. Power Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601). The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark. The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic, polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam.

Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam stenlization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C) Model 233: The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F (121°C to 135°C). Model 223: The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C). All Models: Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterlity assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.

The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 200 (Powerclave) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc for use in health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, hard goods, and linens. The difference between the predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with a more modern microprocessor, software, and an interactive operator interface. The piping remains relatively unchanged, with the addition of a chamber drain float switch to signal possible water-in-chamber conditions and a thermostatic drain discharge temperature control. A minor change on each chamber vessel size has changed the interior chamber width from 24 inches to 26 inches; the length on the mid-sized vessel has changed from 49 inches to 50 inches.

The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls an intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16" x 16" x 26" chamber having a volume 3.9 cubic feet and a 20" x 20" x 38" chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows: For the Model 122 - P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry - P2 GRAV WRAP 2 Gravity Cycle 10 minute exposure at 275°F and 30 minute dry - P3 FLASH 3+ Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry - P4 FLASH 10+ Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry For the Model 123 - P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry - P4 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and o minutes dry For the Model 133 - P1 PREVA WRAP Prevacuum Cycle 3 minute exposure at 275°F and 16 minute dry - P2 PREVA WRP1 Prevacuum Cycle 3 minute exposure at 275°F and 3 minute dry - P3 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and 0 minute dry - P4 FLASH 10+ Gravity Cycle 10 minute exposure at 275°F and 0 minute dry - P5 VAC LEAK TST Air leak Test 3 minute exposure at 268°F and 15 min. leak test

The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 100 (Straightline) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc. for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact) The difference between predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with more modern microprocessor/software, and interactive operator interface. The chamber vessel and piping remain unchanged.