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The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8. Modifications made from the predicate device include: - Additional Gravity cycles - Increase of recommended load capacity. - New version of Programmable Logic control (PLC) and new operating panel (MMI) The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version. The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized. The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.

The Belimed Steam Sterilizer MST-V 3-3-6 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities ... The Belimed Steam Sterilizer MST-V 3-3-6 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterlilzers MST-V 3-3-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Model 5-5-9. The small chamber size incorporates flexibility, and allows operating the sterilizers in the limited space conditions. The Belimed Steam Sterilizer MST-V 3-3-6 is designed to be used for the thermal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays can be sterilized. The Belimed Steam Sterilizer MST-V 3-3-6 is factory equipped with cycles which have been tested in accordance with AAMI/ANS ST8:2008 under defined load conditions. The predicate device with a chamber volume 73 I has been validated previously.

The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).

The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities.

The Belimed Steam Sterilizer TOP 5000, series 24, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers TOP 5000 Series 24 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 series 9 - 18. The larger chamber size (higher chamber) incorporates additional flexibility, and allows operating the sterilizers in an economical way (less floor space required). The Belimed Steam Sterilizer TOP 5000 Series 24 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.

The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 4 -- 8. The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way. Motorized or manually operated vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations: 21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions.

The Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 9 - 18. The smaller Chamber size incorporates additional flexibility, in comparison to Series 9 -- 18, and allows to operate the sterilizer in an economical way. Motorized vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1) | CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD | |---------------------------|-------------------|----------------|------------|----------------------------------------------------------------------------------------------------------------------------------------| | PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays, max.<br>weight of 17 lbs (7.7 kg) each. Fabric packs.<br>Refer to Table 2 for recommended quantities. | | PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 5 minutes | Fabric Packs. | | LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 minutes | 0 minute | Refer to Table 3 for Guidelines | | EXPRESS<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with non porous single instrument | | FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a single Instrument | | FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non porous multiple instruments (max. weight of 17 lbs) | Table 1: Factory programmed Sterilization Cycles

The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities. The device is equipped with factory-programmed sterilization cycles. It is offered in various medium-size configurations with single or double doors and prevacuum or floor flush designs. The device includes microprocessor controller safeguards that abort the cycle and provide signals, alerts, and warnings when required conditions are not met or a malfunction occurs.