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The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities. (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices). The 2545D was validated for use in: Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.

The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The 2545D uses steam as a sterilizing agent, produced by warming up a controlled amount of demineralized water which then flows into the chamber as steam. A heating element wrapped around the chamber maintains the required temperatures and steam. All processes are controlled by the device's computerized control system. To use, the operator fills the water reservoir with water (distilled or purified), loads the trays with cleaned instruments, and manually closes the chamber door. The operator then selects the appropriate sterilization cycle on the user interface. Once "Start" is pressed, the sterilizer automatically performs all necessary operations, including Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status are displayed on the screen. The 2545D is designed with the following external ports and printing functions: - One built-in USB port to enable the operation of an external USB device to record sterilization cycles. - Built-in report printer to print sterilization records. - Built-in memory to record up to 16000 sterilization cycles, which can be exported to a USB device. - Built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates (optional additions). The chamber and door are made of corrosion-resistant 304L stainless steel. It features an LCD Display and touch pad user interface, High Temperature Silicon Rubber door gaskets, a manual door lock, and a door safety interlock. It also has an ASME pressure relief valve and an Overheat Protection (Thermostat@250°C). The device is powered by AC 120V 60 Hz 1750VA. The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam and maintaining its temperature with a heating element. It includes a vacuum mechanism for air removal and drying.

The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.

The Fort Defiance Industries FRONT-LINE Field Sterilizer, model FL135, is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.

The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization. The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber. The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes. The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle. All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.

Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following: - Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs) - Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following: - Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs) - Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs) - Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit is equipped with a height-adjustable steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single-door freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel) 2. Chamber Finish 3. Chamber Door 4. Insulation 5. Chamber Drain System 6. Drain Water Quench (Piping System) 7. Vacuum system 8. Steam Source 9. Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC.

The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices). The T-Top 10 and T-Top 11 devices are validated for use in: - · Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles). - · Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed). This autoclave uses steam as a sterilizing agent. The steam is produced by warming up a controlled amount of water inserted to a pipe heating element, and then to the chamber. This technique saves energy and water consumption. The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber. The autoclave is equipped with a vacuum system, which supports and improves: - . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle. - . Steam penetration into the load; resulting in effective sterilization. - . Temperature uniformity. - . Post sterilization drying phase A touchscreen is used for monitoring and control purposes. The device has 2 built -in USB ports to enable the operation of an external optional barcode printer: - The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates - . One barcode printer can be connected to the machine. - The printer connection to the machine, by using a USB socket, with a dedicated cable . - Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket). - . A barcode printer is an optional addition to the autoclave The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC. The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The T-Top 10 has a manually filled reservoir of demineralized water only. There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front. Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water. The T-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC. The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine. There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option - see software reports in the 510(k) file. The chamber is made of a corrosion-resistant 304L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.

Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MINI has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following: - Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs); wrapped Porous/ Textile load (0.22 lbs) - Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs) - Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)

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The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer is equipped with a height-adjustable, steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single door, freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Series Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.