What makes the FL135 unique from other sterilizers on the market?
The ruggedized FL135 was designed specifically for the austere conditions of military service. It sterilizes 25lbs of instruments within a small cube & weight, and will fit full size sterilization containers (21.1”x12.4”x6.1”). From a transport configuration, it can be operational in 3 minutes. It is fully automatic, and allows for the operator to focus on other critical tasks. It consumes low water (3.4oz/cycle), and has flexible power options (120VAC & 230-240VAC, 15 AMPS). It is capable of transport, operation, and storage in extreme conditions, and can operate at elevations up to 10,000ft. The FL135 has a 3R NEMA classification for protection from rain, sleet, & snow.
What certifications and standards does the FL135 meet?
The FL135 has been cleared for use by the US Food and Drug Administration as a Class II medical device [510(k) number K213457]. The FL135 meets the following standards: The FL135 complies with the applicable requirements of the following five standards: (1) ANSI/AAMI ST55:2016, Table-top Steam Sterilizers; (2) IEC 61010-1 Edition 3.1 2017-01, Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1 General Requirements; (3) IEC 61010-2-040:2020, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials; (4) IEC 61326-1:2020 Electrical equipment for measurement, control, and laboratory use – EMC requirements Part 1: General Requirements; (5) ASME Boiler and Pressure Vessel Code, Section VIII, Division I, Current Edition, Rules for Construction of Pressure Vessels
Is the FL135 FDA cleared and/or CE marked?
Yes, the FL135 has received clearance from the U.S. Food and Drug Administration (FDA) for its safety and effectiveness, as evidenced by 510k Number K213457. However, the FL135 is not CE marked and we have no plans to obtain the CE mark.
How can I get Technical Support?
How do I order replacement parts?
If you are a US DoD customer, you can purchase replacement parts for the FL135 through our ECAT contract with DLA (SPE2DH-22-D-0016.). For all other customers, please email us at sa***@fo*************.com or call 865-408-0100.
Does the FL135 have a National or NATO Stock Number?
Yes, the NATO or National Stock Number is 663001N000948.
How does FDI provide service, support, and training for the FL135?
(1) We provide 25 Operation & Maintenance videos on YouTube. (2) Our comprehensive Technical Manual, accessible HERE, dedicates 43 pages to Maintenance procedures, ensuring a thorough resource for maintenance personnel. (3) Our dedicated call center (865-408-0100 Option #2) offers excellent support. Our team of skilled Engineers is available to assist in troubleshooting and resolving any issues. The convenience of phone and video conferencing enables efficient issue resolution. (4) Tailored Maintenance Training in-country: We extend the opportunity for maintenance training in-country, accommodating groups of up to 8 individuals per class. Our recommended approach involves the “train the trainer” strategy, empowering the military to train 8 technicians who can subsequently share their expertise without further reliance on our support. (5) On-Site Maintenance Training at Our Facility: An alternative option entails maintenance training at our facility for 1 or 2 designated military technicians. These technicians can then return to your home country equipped to train their peers effectively.
Is the FL135 available on the Defense Logistics Agency's Electronig CATalogue (ECAT)?
Yes! The FL135 is on FDI’s ECAT Contract SPE2DH-22-D-0016.
Do you provide other accessories that are important for the operation & mainteannce of the FL135?
Yes, we provide many accessories for the FL135 to support operations & maintenance. To view please click the Accessories button on the FRONT-LINE Sterlizer page
1. Consumables Kit: After 6 months of use or 300 cycles, the FL135 will require replacement consumables, such as the HEPA filter. FDI recommends purchasing at least one kit initially to ensure uninterrupted operation.
2. Sterility Assurance Startup Kit: FDI advises using 3M 1492V Biological Indicators (BI) for sterility assurance. If an incubator and BIs are not currently available, they should be included in your purchase. This kit contains BIs and chemical integrators with a 1-year shelf life.
3. Recommended Spare Parts Kit: This kit is recommended for long-term maintenance. One kit typically supports around 10 FL135 units, though the quantity may vary depending on how the units are distributed and deployed.
4. Maintenance Tool Kit: While many maintenance tools may already be available to your technicians, a torque wrench—potentially unique to FL135 servicing—might not be. Consider this kit to address any gaps.
5. Table: Though not required, FDI offers a strong, lightweight table designed to support the FL135. It provides a stable and convenient setup option.
6. Distilled Water Generator: Per FDA requirements, distilled water is essential for the FL135. FDI offers a high-quality generator in a protective hard case, ensuring reliability and portability.
7. Soft Case: The FL135 was designed for most situations without needing a hard case, prioritizing a ruggedized design for austere environments. However, FDI recommends the optional Soft Case to protect against dust and dirt during transport. It features durable carry handles for ease of transport.
8. Ruggedized Hard Case: For added protection, consider this heavy-duty hard case which is suitable for demanding environments. It weighs 65 lbs. and measures 37”x31”x27”.
What are the key safety features of the FL135?
Chamber Door Safety: A mechanical lock prevents a user from unsealing the door if the FRONT-LINE is running a cycle or the chamber is pressurized above atmospheric pressure. A manual unlock toggle allows the user to unlock the door in power loss or no power situations. There are two door safety sensors: (1) the door tight sensor (DS-1) is energized when the door is closed in the door frame and completely tight and (2) the door lock sensor (DS-2) is energized when the mechanical lock is in the locked position.
Heater Overtemperature Protection: Boiler full condition (all phases of a cycle except dry): 1. The primary safety feature to prevent overtemperature is a boiler liquid level sensor, which controls the water level to keep the heater elements immersed. 2. The secondary safety circuit uses thermocouples inside each cartridge heater, which allows the heater temperature to be continuously monitored. Boiler empty condition (during dry phase): 1. The primary safety feature to prevent overtemperature is air flowing through the chamber to carry away the heat from the heaters. The air flow is sensed through a pressure rise in the chamber measured by the chamber pressure sensor. 2. The secondary safety circuit uses thermocouples inside each cartridge heater, which allows the heater temperature to be continuously monitored.
Overpressure Protection: A pressure transmitter monitors the chamber pressure during operation. The secondary safety feature is a pressure safety valve (PSV) mounted to the chamber.
Does the FL135 have a printer to print out the cycle record?
No. A printer was discussed with key representatives from the US DoD and because of several issues, a printer was not included on the FL135. The main concerns are (1) printers on sterilizers in military field environments have historically proven to be maintenance headaches, (2) thermal paper commonly used for printers will often overexpose in high-temperature environments, (3) requiring printer paper increases the logistical “footprint” for the sterilization capability.
Is there a way to monitor and log sterilization cycles for record-keeping purposes?
Yes! The LOG button on the mainscreen of the touchscreen controller will take you to the Cycle Records. The LOG holds 200 records. Once 200 records are reached, the oldest record is deleted to allow each new cycle to be recorded. Some operators will elect to take pictures of each Cycle Record using a handheld device. Others may prefer to use a paper LogBook.
Does the FL135 have a USB connection to export cycle data?
No. Due to cybersecurity risk, a USB connection is not included on the FL135.
Do I need to access the back of the FL135 during normal daily operation?
No. During normal daily operation, you do not need to access the back of the FL135, even for a routine water changeout. The main drain on the front bottom right of the device can be used (see Section 4.13 in the Technical Manual). The rear drain and vent valves are used for initial setup and for preparation for transport (see Section 4.15 in the Technical Manual).
What are the water quality requirements?
Distilled water is required by the US FDA for any surgical instrument steam sterilizer. Using distilled water protects the sterilizer from scale buildup in the plumbing and on the heaters, which keeps cycle times short and eliminates sterilizer downtime to clean the boiler surfaces. See Section 1.2 in the Technical Manual for the Recommended Water Quality Specification. FDI can provide you with a distilled water generator if needed. For more information please see our FRONT-LINE page and then click on the FRONT-LINE Accessories button.
What if distilled water is not available?
Distilled water is required by the US FDA. However, in a military field environment, there may be situations where distilled water is not available. Operators will be required to make a risk-based decision on whether using the available water poses less risk than not using the FL135 for the sterilization of the instruments needed. When this occurs, we highly recommend following the Chamber and Boiler Cleaning Procedure in Section 4.14 of the Technical Manual. In addition, seek to obtain a distilled water generator as soon as possible (which FDI can provide).
How much water does the FL135 use?
On average, the FL135 uses about 3.4oz (100ml) per cycle. Approximately one gallon of water is required to fill the water tank prior to operation. A water changeout is required every 14 days, or 50 cycles, whichever comes first. See Section 4.13 in the Technical Manual.
Does FDI provide a distilled water generator?
Yes! FDI sells a Distilled Water Generator. Please reference the Accessories Page by clicking on the Accessories button on the FRONT-LINE Field Sterilizer webpage for more details or call 865-408-0100.
How long does it take to setup and be operable?
The FL135 can be set up and operable in less than 3 minutes.
How much does the FL135 weigh?
The FL135 by itself weighs 145lbs. The logistical weight of 149lbs includes the Accessory bag contents and the Soft Case.
Can the FL135 operate in varying weather conditions, altitudes and temperatures?
Yes! The FL135 was designed as a field sterilizer and was designed/tested for extreme environmental conditions. The FL135 has a 3R NEMA classification (protection from rain, sleet, snow), can operate at 10,000ft altitude and in temperatures between 35°F to 130°F (1.7°C to 54°C), and can be stored in temperatures between -65°F to 180°F (-54°C to 82°C).
What types of instruments can be sterilized?
Follow the official Instructions for Use for the items you are needing to sterilize. Also, ensure compliance with the Indications for Use of the FL135 sterilizer, which are autoclaves 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.
What is the maximum instrument load capacity when using the wrapped instrument sterilization cycle?
25lbs (11.3kgs)
What are the cycle times?
Please reference our official FL135 Data Sheet by clicking on the Data Sheet button located on the FRONT-LINE Field Sterilizer webpage.
Does the FL135 come with a user manual or training materials?
Yes! The FL135 ships with a hard copy Technical Manual. A Quick Start Guide is also available to get up and running fast. The Technical Manual is available for download on our website. We provide 25 operator and maintenance training videos on YouTube.
What are the dimensions and weight of the FL135?
The FL135 weighs 145lbs (65.8 kgs) and has outside dimensions of 32″ x 21.5″ x 23.5″ (81.3 x 54.6 x 59.7cm)
Is the FL135 a dynamic air removal sterilizer?
Yes! The FL135 sterilizer is a dynamic air removal sterilizer that uses an FDA cleared process called Steam-Flush Pressure-Pulse (SFPP), that enables proper conditioning of the load prior to the exposure phase. There are significant benefits with SFPP. Since the FL135 chamber is never under vacuum, there is no potential for an air leak which can compromise effective sterilization. In addition, vacuum leaks are can be very difficult and time consuming to locate and repair, especially in a field environment.
Is the FL135 a pre-vac sterilizer?
No. The FL135 sterilizer is a dynamic air removal sterilizer that uses the FDA cleared process called Steam Flush Pressure Pulse (SFPP), that enables proper conditioning of the load prior to the exposure phase. There are significant benefits with SFPP. Since the FL135 chamber is never under vacuum, there is no potential for an air leak which can compromise effective sterilization. In addition, vacuum leaks are can be very difficult and time consuming to locate and repair.
Does the FL135 have a gravity sterilization cycle?
No. Gravity cycles do not effectively remove the air within the chamber or tray/container. The FL135 sterilizer is a dynamic air removal sterilizer that uses the FDA cleared process called Steam-Flush Pressure-Pulse (SFPP), that enables proper conditioning of the load prior to the exposure phase. There are significant benefits with SFPP. Since the FL135 chamber is never under vacuum, there is no potential for an air leak which can compromise effective sterilization. In addition, vacuum leaks are can be very difficult and time consuming to locate and repair, especially in a field environment.
Can the FL135 process solutions/liquids?
No. Processing of liquids is not included in the Intended Use. Since most liquids/solutions are now provided in sterile packages, the need to have this capability is very low. Also, FDA requirements on steam sterilizers that process liquids are now very stringent. Normally, specialized design features are required to meet these requirements and these devices are most commonly used with pharmaceutical type sterilizers.
Does the FL135 have a 250°F cycle?
Yes, for Textiles, Wrapped Instruments/Pouches, and Handpieces
Does the FL135 support sterilization of non-metallic surgical items?
We recommend you refer to the official Instructions for Use for the items you are needing to sterilize.
Do you have videos for operator and maintenance training?
Yes! We provide 25 Operation & Maintenance videos on YouTube.
Can we stack one FL135 on top of another?
Yes! The front panel on the bottom FL135 would need to be removed. We can supply brackets to ensure stability. Please contact us at te*********@fo*************.com for additional support.
What are noise levels during operation?
The noise levels for the FL135 are 70 dBA (peak) and 57 dBA (background).
Is there a need for special storage procedures when the FL135 is not in use?
Yes. Since the FL135 is a steam sterilizer that uses water, it is critical that ALL of the water is drained from the system. Use the main (power) drain on the front of the FL135 to ensure all water has been flushed out of the system. Open the Drain Valve and the Vent Valve on the back of the FL135 and LEAVE OPEN. The FL135 can be stored in conditions from -65°F to 180°F. Reference section 4.15 in the Technical Manual for detailed procedures for preparing for Transport or Storage.
How does the FL135 perform in high-humidity or wet conditions?
The FL135 has been designed to operate reliably in these conditions. The FL135 was successfully tested under 88% noncondensing conditions. In addition, the FL135 has a 3R NEMA classification for protection from rain, sleet, & snow.
Can the FL135 be transported without a ruggedized hard case?
Yes, the FL135 was designed to not necessarily require a large, heavy hard case. If you choose to not transport the FL135 in a hard case, we highly recommend the use of our Soft Case, a lightweight but durable carry case that can be used to transport the sterilizer. This Soft Case keeps dust/dirt from the device and prevents potential damage from scratches. Depending on the potential risk associated with your logistical transport conditions, you may still choose to put the FL135 in a hard case.
What are the preventive maintenance requirements?
Please reference Section 6.1 Preventive Maintenance Schedule in the Technical Manual for details. At 6 Months of use, or 300 Cycles, the PM tasks are 1. HEPA Filter Replacement, 2. Air Inlet Filter Inspection/Cleaning and 3. Water Filter Cleaning. At 12 Months of use, or 600 Cycles, the PM tasks are 1. PSV Test, 2. Chamber Doorpost Threads Lubrication, 3. Heat Exchanger Inspection, 4. Heat Exchanger Fan Inspection, 5. Electrical Wiring Inspection, 6. Doorpost Screws Re-torque, 7. Replacement Parts Stock Check.
What is the standard warranty for the FL135?
The warranty for the stainless steel chamber is 10 years and the warranty for all other parts is 3 years. We expect the FL135 to last 15 years, assuming no misuse.
What is the expected lifespan of the FL135 under continuous use?
We expect the FL135 to last 15 years, assuming no misuse.
What was testing standard was used for shock & vibration?
Shock (drop): drop from 30” on Bottom (flat), Side (flat), and Front corner (over Center of Mass) per 810G guidance. Vibration: MIL-STD-810G Category 4 (trucks/trailers) and 9 (aircraft/helicopter) vibration curves in all X, Y, Z planes.
What are the environmental specifications for the FL135?
Operating Temperature range: 35°F to 130°F (1.7°C to 54°C). Storage Temperature range: -65°F to 180°F (-54°C to 82°C). Operating Altitude Range: 0 to 10,000 ft (0 to 3048 m). Maximum Relative Humidity: 88%, non condensing.
Can the FL135 be stored and/or transported in freezing conditions?
Yes, the FL135 can be stored or transported in Arctic conditions down to -65°F. However, it is critical to ensure that ALL water has been drained from the system by following the Transport and Storage Procedure in Section 4.15 of the Technical Manual.
What failures have occurred in the field?
Door lock switch and sight glass hazing. Both of these issues have been resolved.
What is the Mean Time Between Failures (MTBF) for the FL135?
The MTBF for our limiting component is currently estimated at 20,000 cycles. Previously, the door lock switch was failing well before the 20,000-cycle threshold. However, this issue has been resolved by implementing a more reliable microswitch. In real-world conditions, we anticipate that most failures will likely result from misuse, which could cause a component to fail before reaching 20,000 cycles.
What is the shelf life of the PLC battery?
The PLC battery is rated to last 7-10 years. When the sterilizer is turned ON, the battery will charge. To ensure a charged battery, the sterilizer should be turned ON for at least 8 hours per year.
What power plugs are available?
The FL135 comes standard with two power cords with different plugs on the ends. The 120V power cord has a NEMA 5-15P plug. The 240V power cord has a NEMA L14-30P plug. We can customize the power cords to suit your requirements. For example, we can provide the Type F plug for 230V which is common in Europe.
What power supply will the FL135 operate on?
The FL135 will operate on either 120VAC, 1PH, 50/60 Hz, 15 Amps (low power option) or 230-240VAC, 1PH, 50/60 Hz, 15 Amps (high power option for faster cycle times)
What are the FL135's energy consumption rates?
The max power consumption for the FL135 is 1800 Watts using 120 VAC, and 3400 Watts using 240 VAC.
What is the heat output from the FL135 in a room during a cycle?
About 450 Watts
What are the recommended generator requirements for the FL135?
The FL135 can operate on generator power if the generator supplies 120VAC, 1PH, 50/60 Hz, 15 Amps for the Low power option, or 230-240VAC, 1PH, 50/60 Hz, 15 Amps for a High power option (faster cycles). Please note that generators should be sized with “margin”. For example, for the 240VAC option, we would recommend at least a 4500 Watt generator.
