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FDI FRONT-LINE FL135 Technical Manual

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Technical Manual
Model FL135
Fort Defiance Industries LLC (FDI)
2411 Maremont Parkway
Loudon, TN 37774
Phone: (865) 408-0100
techsupport@fortdefianceind.com
FL-8000 Rev 04 – 09 APR 2025

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  • Page 1 Technical Manual Model FL135 Fort Defiance Industries LLC (FDI) 2411 Maremont Parkway Loudon, TN 37774 Phone: (865) 408-0100 techsupport@fortdefianceind.com FL-8000 Rev 04 – 09 APR 2025...
  • Page 2  ASME Boiler and Pressure Vessel Code, Section VIII, Division I, Current Edition, Rules for Construction of Pressure Vessels Fort Defiance Industries (FDI) is ISO 13485:2016 certified and Food and Drug Administration compliant for the design and manufacture of sterilizers for the medical device industry.

  • Page 3: Continuous Improvement

    Continuous Improvement Fort Defiance Industries LLC (FDI) is committed to providing our customers with a safe and effective product that is simple and easy to operate and maintain. As an ISO 13485:2016 certified company, we have a strong desire to continually improve. If you have any feedback regarding the FRONT-LINE Field Sterilizer (FRONT-LINE) or this technical manual, please contact us.

  • Page 4: Table Of Contents

    Table of Contents Part 1 – OPERATION ........................7 General Information ......................8 Operator Notes ....................... 8 Safety Precautions ......................9 Symbols ........................10 Included Contents ......................11 Optional Accessories ....................12 Sterilizer Overview ......................13 Safety Features Overview .................... 13 Cycle Phases Sequence ....................
  • Page 5 4.16 Extra Dry ........................43 4.17 Faults, Alerts, and Warnings ..................43 4.18 Operational Situations and Responses ................ 47 Part 2 – MAINTENANCE ......................49 General Maintenance Information ..................50 Maintenance Log ......................51 Tools and Materials Required for Maintenance ............52 Replacement Parts and Material List ................

  • Page 6: List Of Tables

    List of Tables Table 1. Materials of Construction ................. 18 Table 2. Recommended Water Supply Quality Specification ........18 Table 3. Consumable Items and Part Numbers ............19 Table 4. Custom Cycle Options ..................37 Table 5. Alerts/Warnings and Corrective Actions ............45 Table 6.

  • Page 7: Part 1 - Operation

    Part 1 – OPERATION...

  • Page 8: General Information

    1 General Information 1.1 Operator Notes...

  • Page 9: Safety Precautions

     Authorized Parts – Repair parts must be authorized for use in the FRONT-LINE and must be sourced from Fort Defiance Industries LLC (FDI). Use of unauthorized parts could reduce the safety or effectiveness of the device and will void the warranty.

  • Page 10: Symbols

    FRONT-LINE is designed to sterilize loads per the intended use as specified in Section 1.9. If you have any question or concern about a specific material, instrument, or device, please contact the manufacturer of the device regarding the recommended IFU. ...

  • Page 11: Included Contents

    1.4 Included Contents The FRONT-LINE Field Sterilizer includes the following: 1. QuickStart Instructions – (P/N: FL-8001, shipped in box) 2. Chamber Shelf – (P/N: FL-9064) 3. Accessory Bag – (P/N: FL-9075, shipped inside chamber, see below) Accessory Bag Contents: Power Cord, 120 VAC – (P/N: FL-9002) Power Cord, 230-240 VAC –...

  • Page 12: Optional Accessories

    8. Case, Soft (Model FL135) – (P/N: FL135-7010) 9. Case, Ruggedized Hard, Transport – (P/N: FL-9094) 10. Power Cord, Type-F, 230 VAC – (P/N: FL-9105) 11. Power Cord, Class-L, 208 VAC – (P/N: FL-9121) Please contact FDI to purchase optional accessories: Email: sales@fortdefianceind.com Phone: +1(865) 408-0100...

  • Page 13: Sterilizer Overview

    1.6 Sterilizer Overview The FRONT-LINE Field Sterilizer (FRONT-LINE) is a highly portable, dynamic air removal sterilizer that offers the highest level of sterility assurance to the field environment using steam as the sterilant. The FRONT-LINE can run on either 120 or 230-240 VAC and uses a closed-loop water recycling system that reclaims the condensate and exhausted steam, allowing it to run up to 50 cycles before the water needs to be changed.
  • Page 14 2. The secondary safety feature is a high temperature cutoff using thermocouples inside each cartridge heater. Boiler empty condition (during dry phase): Cartridge Heaters A. The primary safety feature to prevent overtemperature is sensing air flow via a pressure rise in the chamber measured by the chamber pressure sensor. B.

  • Page 15: Cycle Phases Sequence

    1.8 Cycle Phases Sequence Schematic of a Steam Flush Pressure Pulse (SFPP) Cycle The following is a description of the phases of a FRONT-LINE cycle: 1. The water pump automatically fills the boiler section in the chamber. 2. Water is heated to prepare for the steam flush. 3.

  • Page 16: Indications For Use And Sterilization Cycles

    1.9 Indications for Use and Sterilization Cycles 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 and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.

  • Page 17: Specifications

    1.10 Specifications 120VAC ±10%, 1PH, 50/60 Hz, 15 AMP Power Requirements: 230 – 240VAC ±10%, 1PH, 50/60 Hz, 15 AMP 120VAC: NEMA 5-15P (IEC Type B) (US) 240VAC: NEMA L14-30P (US) Electrical Receptacle: WARNING: The receptacle must be properly grounded. It is recommended to use a dedicated 20 Amp circuit.

  • Page 18: Materials Of Construction

    1.11 Materials of Construction Table 1. Materials of Construction Component Material Chamber 316 stainless steel (electropolished) Door 6061-T6 aluminum Chamber Shelf 304 stainless steel (electropolished) Water Tank 316 stainless steel (electropolished) Heat Exchanger Copper Plumbing Teflon ® -based (PFA), silicone, brass, stainless Solenoid Valves Brass, EPDM seal Frame...

  • Page 19: Sterility Assurance Products

    Indicator 275°F P/N: FL-9044 1.14 Consumables Table 3 provides the consumables recommended for daily use, sterility assurance, and preparing sterilization loads. All consumables can be purchased from FDI using one of the following methods: Email: sales@fortdefianceind.com Phone: +1(865) 408-0100 Table 3. Consumable Items and Part Numbers...

  • Page 20: Installation, Setup, And Qualification

    2 Installation, Setup, and Qualification 1. Install the sterilizer in a suitable location: CAUTION: Two people are required to lift the FRONT-LINE. Use the front and rear handles as shown below. A. Place the sterilizer on a level surface capable of safely supporting 185 lbs. (84 kg).

  • Page 21: Connect To Power

    C. Check that the heat shield inside the chamber is securely fastened. D. Check that the chamber drain screen is installed hand tight. E. Pour distilled water in the back of the chamber and ensure it flows towards the front chamber drain screen. Shim the back of the sterilizer if necessary. Heat Shield Chamber Drain Screen (protects plumbing from...
  • Page 22 B. Verify performance of the sterilizer per AAMI ST79 standards before placing the sterilizer into service. NOTE: FDI recommends completing three consecutive sterilization cycles with biological indicators in the load. Always follow the BI manufacturer’s instructions. For information on biological indicators, see Section 1.13.

  • Page 23: Installation Diagram

    2.1 Installation Diagram Recommended room ventilation: 10 air changes / hour Max heat transmitted to room: 3450 Watts FL135 Length: 32 in. (81.3 cm) Width: 21.5 in. (54.6 cm) Height (transport panel open): 23.5 in. (59.7 cm) Weight (fully loaded, wet): 185 lbs.

  • Page 24: Controls And Indicators

    3 Controls and Indicators 3.1 Front Views Magnets for Securing Panel Do not use within 6 in of susceptible medical devices Quick Start Guide Label Use to setup sterilizer. Main Power Switch Use to power on sterilizer. Water Fill Port (P/N:FL-9000) Use distilled water only.

  • Page 25: Left-Side View

    3.2 Left-side View Heat Exchanger Exhaust Hot air from condensed steam. Do not block. Panel Latches Use standard screwdriver to twist latches counterclockwise to unlock and lift panel upwards to remove. Rear Carry Handle(s) Left-side Panel Front Carry Handle(s)

  • Page 26: Back View

    3.3 Back View Panel Latches Use standard screwdriver to twist latches PSV located behind counterclockwise to panel unlock and lift panel Back Panel Manual Drain Main Power Connector (P/N:FL-9042) (P/N:FL-9001) Use to drain the system if no Use to connect either Chamber Vent power is available and the 120 VAC or 230-240...

  • Page 27: Right-Side View

    3.4 Right-side View Panel Latches Use standard screwdriver to twist latches counterclockwise to unlock and lift panel upwards to remove. Electrical Enclosure Air Intake Not a handle. Do not block. Transport Checklist Front Carry Handle(s) Right-side Panel Rear Carry Handle(s)

  • Page 28: Operating Procedure

    4 Operating Procedure NOTE: The following instructions assume the FRONT-LINE is set up, qualified for use, and distilled water has been added. Reference Section 2. 4.1 Preparing Sterilizer Loads WARNING: Aways use AAMI ST79 or EN equivalent for directions on loading the sterilizer, wrapping instruments, preparing instruments, verifying performance, and any other load-related questions.

  • Page 29: Door Operation

    3. The touchscreen controller will boot up and go to the HOME screen. 4. The sterilizer is ready for use. There is no warmup required. 4.3 Door Operation CAUTION: Hot steam and condensate may flow out of the chamber when the door is opened.

  • Page 30: Loading And Unloading The Sterilizer

    CAUTION: Do not overtighten the door. Once the door handles stop, the door is tight. NOTE: If the door does not successfully unlock after a completed cycle or a fault, a screen as shown below will prompt the user to: A.

  • Page 31: Setup And Basic Functions

    Chamber shelf (flat side up) 3. If pouches or other handpieces are being sterilized, flip the chamber shelf so the pouch rack is facing up. Use one pouch only per slot, facing the same direction. Chamber shelf (pouch rack facing up) 4.5 Setup and Basic Functions To navigate to the SETUP screen, press SETUP from the HOME screen.

  • Page 32: Running A Sterilization Cycle

    If water is left in chamber, use to pump water into water tank NOTE: The Factory Mode is password protected and can only be used by FDI factory- trained personnel. 4.6 Running a Sterilization Cycle The FRONT-LINE is automatically controlled with a touchscreen controller (PLC) that performs pre-programmed sterilization cycles.
  • Page 33 3. Select the correct cycle for the instrument load. Textile packs Immediate use steam sterilization Wrapped trays, sterilization Extra dry (no cases, and conditioning or pouches exposure) Dental handpieces 4. Select the appropriate cycle temperature, exposure time, and dry time. Then press CONFIRM.

  • Page 34: Log (Cycle Records)

    7. The sterilizer will automatically complete the cycle phases sequence as described in Section 1.8. The cycle running screen shown below displays all process monitoring information. Date and time Live elapsed cycle time Current phase of cycle Cycle parameters Time remaining (selected by user) in current phase Press to cancel...
  • Page 35 displays a summary of the cycle results. The DETAIL screen displays information about the conditioning pulse pressures, temperatures, and times. 4. All cycle parameters can be read from the log screen to allow the user to verify cycle parameters such as minimum and maximum temperature, exposure time, etc.

  • Page 36: Status Screen

    Detail Log Screen Acceptable Value Ranges: Temperature Pressure Range Phase Title Description Range (°F) (psig) S. FLUSH Steam Flush PRESS 1 Pressure Pulse 1 240 – 255 14 – 19 EXH 1 Exhaust 1 215 – 245 5 – 10 PRESS 2 Pressure Pulse 2 240 –...

  • Page 37: Custom Cycles

    4.9 Custom Cycles From the HOME screen, select CUSTOM. This feature allows the user to run custom temperature, exposure time, and dry time combinations at the user’s own risk. Please see Table 4 for the options on a custom cycle. WARNING: Only the standard AAMI cycles listed in Section 1.9 have been...

  • Page 38: Daily Shutdown Procedure

    6. Run a sterilization cycle with a biological indicator (BI) in the load to ensure the sterilizer is functioning correctly. Always follow the BI manufacturer’s instructions. Listen and inspect for any steam leaks or unexpected sounds. 7. Proceed with normal sterilization cycles as needed. 4.11 Daily Shutdown Procedure WARNING: If freezing temperatures are possible around the sterilizer, all water...

  • Page 39: Water Changeout Procedure

    Every 300 Cycles: Maintenance Reminder The MAINTENANCE REMINDER screen reminds maintenance technicians to check and follow the recommended preventive maintenance (PM) schedule (see Section 6.1). This maintenance is critical for the continued reliable operation of the sterilizer. All maintenance must be performed by qualified personnel. 4.13 Water Changeout Procedure REQUIRED FREQUENCY: 50 CYCLES OR 14 CALENDAR DAYS Check...

  • Page 40: Chamber And Boiler Cleaning Procedure

    Check Task 3. Remove the drain hose: A. Line up the coupling sleeve and push back on the sleeve. B. Store the hose in the Accessory Bag. C. Ensure the two valves are closed at the rear of the sterilizer. 4.

  • Page 41: Transport And Storage Procedure

    Check Task 2. With the black cap tight, slightly loosen the white cap on the FRONT-LINE Cleaning Solution bottle. Squeeze the bottle until cleaning fluid fills to the top line (1/2 oz) in the smaller reservoir. Remove the white cap and pour measured solution through the front water fill port.
  • Page 42 Check Task If power is not available, open the rear manual valves and drain the sterilizer completely. Using the standard screwdriver from the Accessory Bag, open the valves slowly to verify that no pressure remains in the chamber. 2. Valves Open: Keep rear valves open for transport and storage. Note that some remaining water/steam can exit when these valves are opened.

  • Page 43: Extra Dry

    4.16 Extra Dry After a completed sterilization cycle, if the user notices visual condensation and the need for additional dry time, use this feature to run the sterilizer dry function. To access, select EXTRA DRY from the CYCLES screen. WARNING: This feature does not include conditioning or exposure phases.
  • Page 44 In-cycle FAULT screen(s) Screen Screen Fault number and name Load not sterile warning Sterilizer will Operator vent and stop next step in a safe state If a fault occurs outside a cycle during system idle, the FAULT screens show the fault number and name but will not display “load not sterile”...

  • Page 45: Table 5. Alerts/Warnings And Corrective Actions

    ALERT screen example Alert number and name Address the alert, then press RESET to clear the alert WARNING screen example Warning number and name Load not sterile warning Operator next step Table 5. Alerts/Warnings and Corrective Actions Alert/Warning Description Corrective Action Navigate to the SETUP screen and select WATER RESET to pump any water left in the boiler...
  • Page 46 Alert/Warning Description Corrective Action Time since last See Section 4.13 - Water Water reminder has Changeout Procedure to drain ALERT 104 Changeout reached 14 the entire system and refill the Required days or 50 sterilizer with distilled water. cycles. User attempted Close and tighten the door to start a cycle completely to start a cycle.

  • Page 47: Operational Situations And Responses

    4.18 Operational Situations and Responses Cycle and Touchscreen Controller-related Situations What do you do if … Response You experience a power Flip the control power switch to the OFF position. When failure during operation? the power returns, flip the control power switch ON. If the power outage was short, there will still be pressure in the chamber.
  • Page 48 What do you do if … Response You hear or see a steam If it is safe to do so, wait for the cycle to finish and then leak at the door? inspect the door frame and door gasket for any debris that could prevent a good seal.

  • Page 49: Part 2 - Maintenance

    Part 2 – MAINTENANCE...

  • Page 50: General Maintenance Information

    5 General Maintenance Information Maintenance Videos Please visit the FDI video channel for step-by-step videos on the maintenance of the FRONT-LINE. Scan the QR code below, click on the hyperlink, or enter the Web address listed to access these videos.

  • Page 51: Maintenance Log

    5.1 Maintenance Log Cycle Technician Date Task(s) Performed Notes Count Initials...

  • Page 52: Tools And Materials Required For Maintenance

    The items listed below are less readily available than standard tools (e.g., standard or flathead screwdriver, open-ended wrenches) used to maintain the FRONT-LINE. These tools are not provided with the FRONT-LINE but are available for purchase from FDI using the contact information below.

  • Page 53: Replacement Parts And Material List

    Sections 7.8 and 7.9, respectively. Parts marked with an * are FDI recommended spare parts to stock. All parts, unless otherwise noted, are replacement only and cannot be serviced separately.
  • Page 54 Part Item Description Number GLOVES, HEAT RESISTANT FL-9049 GREASE, HIGH TEMP (275°F) FL-9048 HANDLES, DOOR FL-9038 HEAT EXCHANGER FL-9065 HEATER, 1650W (H-1&2) CARTRIDGE FL-9006* HOSE, DRAIN FL-9053 INDICATOR, 3M 1492V BIOLOGICAL FL-9044 INDICATOR, CROSSTEX SPORVIEW SVT-050 FL-9046 BIOLOGICAL KIT, CONSUMABLES FL-9108 KIT, MAINTENANCE TOOL FL-9085...

  • Page 55: Post-Maintenance Checklist

    WRENCH, TORQUE, 3/8", 150 FT-LBS. FL-9047 5.4 Post-maintenance Checklist FDI recommends inspecting all work and using the following checklist after any intrusive maintenance (e.g., replacing a solenoid valve) to ensure the sterilizer is ready to be returned to service. Check Task 1.

  • Page 56: Torque Specifications

    NOTE: FDI recommends completing three consecutive sterilization cycles with biological indicators in the load. Always follow the BI manufacturer’s instructions. 5.5 Torque Specifications Follow the torque specifications below when performing any maintenance task on the FRONT-LINE:  4-40 Screw: 5-6 inch-lbs.

  • Page 57: Preventive Maintenance

    6 Preventive Maintenance 6.1 Preventive Maintenance (PM) Schedule The following PM schedule should be followed for all in-service sterilizers. These procedures only apply to sterilizers that are in use. Perform the outlined maintenance procedures only when the sterilizer is operational. Table 6.

  • Page 58: Six-Month Preventive Maintenance

    6.2 Six-month Preventive Maintenance WARNING: To avoid a potential electrical shock or burn hazard, be sure the sterilizer has been de-energized and depressurized prior to performing these tasks. EVERY 6 MONTHS OR 300 CYCLES (whichever occurs first) Check Task 1. Replace the HEPA Filter. See Section 8.3. 2.
  • Page 59 Check Task d) Replace the back panel. 2. Lightly lubricate the chamber doorpost threads using high temperature (275°F) NLGI #2 grease. 3. Inspect the heat exchanger behind the left-side panel and, if dirty, clean by blowing out with compressed air or spraying down with water.

  • Page 60: Interior Component Diagrams

    7 Interior Component Diagrams 7.1 Front Views Door Solenoid (SOLA-1) (P/N:FL-9086) Door Lock Sensor (DS-2) (P/N:FL-9007) Door Tight Sensor (DS-1) (P/N:FL-9057)

  • Page 61: Left-Side View

    7.2 Left-side View Sight Gauge Water Tank Heat Exchanger (P/N:FL-9039) (P/N:FL-9079) (P/N:FL-9065) Water Filter (F-1) (P/N:FL-9005) Air Out Valve (SOLV-4) (P/N:FL-9011) Boiler Drain Valve Chamber Drain Boiler Level Water Pump (P-1) (SOLV-1) Valve (SOLV-2) Sensor (LS-1) (P/N:FL-9008) (P/N:FL-9009) (P/N:FL-9010) (P/N:FL-9014)

  • Page 62: Back View

    7.3 Back View Pressure Safety Air Pump Controller Valve (PSV-1) Assembly (P/N:FL-9017) (P/N:FL-9074) Water Tank Level Air In Valve (SOLV-3) Sensor (LS-2) (P/N:FL-9012) (P/N:FL-9014) Service Port 1/4" ISO 228/1 (BSPP) Chamber Vent (DV-3) (P/N:FL-9040) Manual Drain (DV-1) (P/N:FL-9042) Cartridge Heater (H-1) Cartridge Heater (H-2) (P/N:FL-9006) (P/N:FL-9006)

  • Page 63: Right-Side View

    7.4 Right-side View Chamber Pressure Air Inlet Filter Sensor (PT-1) (P/N:FL-9021) (P/N:FL-9019) Chamber Temperature AC Filter Box Sensor (RTD-1&2) (P/N:FL-9015) AC Filter Circuit Board (inside) (P/N:FL-9034) 7.5 Top View Water Tank Heat Exchanger Breather Fan (EF-1) (P/N:FL-9020) (P/N:FL-9068) HEPA Filter (F-2) (P/N:FL-9022) Air Pump (P-2) (P/N:FL-9016)

  • Page 64: Bottom View

    7.6 Bottom View Boiler Level Check Valve (CV-2, 1.5 PSI) Sensor (LS-1) (P/N:FL-9067) (P/N:FL-9014)

  • Page 65: Electrical Enclosure View

    7.7 Electrical Enclosure View Enclosure Exhaust Relay Circuit Air Pump Spare Master Relay DC Power Fan (EF-2) Board Fuse, 10 AMP (K2) Supply (PS-1) (P/N:FL-9069 (P/N:FL-9036) (P/N:FL-9130) (P/N:FL-9025) (P/N:FL-9028) Right View Heater Control 20 AMP Circuit Air Pump Heatsink Fan Air Inlet Filter Relay (SSR-H1) Breaker...

  • Page 66: Piping And Instrument Diagram

    7.8 Piping and Instrument Diagram...
  • Page 67 FRONT‐LINE FL135 Piping and Instrument Diagram REV A 14 JAN 2025...

  • Page 68: Electrical Wiring Diagram

    7.9 Electrical Wiring Diagram...
  • Page 69 FRONT‐LINE Electrical Diagram Model FL135 24V-J10 FROM INSTR. DC BUS (3C RED) 3C RED HV/LV STATUS SIGNAL PLC-J9 TO PLC (OPEN FOR HIGH VOLTAGE) J1A-I4 (3C BLACK) 3C BLACK LV-J7 TO POWER SWITCH (2C RED) 2C RED A2-J6 TO K13 COIL (3C WHITE) 3C WHITE A2-J6 FROM POWER SWITCH (2C BLACK) 2C BLACK...
  • Page 70 FRONT‐LINE Electrical Diagram Model FL135 SURF. HEATER CONTROL RELAY SSR-H2 MAIN MASTER SURF. HEATER MODE SH-1 SSR-H1 RELAY RELAY SELECT RELAY 2 SURF. HEATERS, 1200W TOTAL @120VAC, CART. HEATER 24Ω EACH CART. HEATER MODE CONTROL RELAY SELECT RELAY MAIN SH-2 POWER SWITCH 2 CART. HEATERS, FROM AC LINE PCB LV-J7 (2C RED) 1650W @120VAC, 8.73Ω...
  • Page 71 FRONT‐LINE Electrical Diagram Model FL135 PROGRAMMABLE LOGIC CONTROLLER WHITE BLUE PLC CPU GREEN HE-XC1E6-652 DOOR TIGHT SNSR DS-1 (NO) GREEN DOOR LOCK SNSR DS-2 (NO) YELLOW VIOLET FROM INSTR. DC BUS BMT-1 BMT-2 MAIN DC SUPPLY OK SIGNAL ORANGE Discrete Input (BMT’S LOCATED ON SURFACE HEATER) I1 - I12 AC LINE PCB PLC-J9 (HV/LV STATUS) BLUE...

  • Page 72: Maintenance Procedures

    Maintenance work must be performed by qualified maintenance technicians. Maintenance Videos Please visit the FDI video channel for helpful and informative videos on the maintenance of the FRONT-LINE. Scan the QR code below, click on the hyperlink, or enter the Web address listed to access these videos.

  • Page 73: Sight Glass Cleaning

    8.1 Sight Glass Cleaning NOTE: Algae may form in the sight glass due to heat and light. It is a normal occurrence and does not affect sterilization. This procedure does not need to be performed on a regular basis. Step 2. Sight glass Step 6.

  • Page 74: Chamber Door O-Ring Replacement

    8.2 Chamber Door O-ring Replacement Removal hole 1. Starting at the removal hole at the 12 o’clock position and being careful not to scratch/damage the groove, use a small pick or standard screwdriver to pick the O-ring out of the groove. 2.

  • Page 75: Door Sensor Calibration

    8.4 Door Sensor Calibration 1. Determine which sensor is out of adjustment: a. If the operator has experienced the following faults or alerts, the Door Lock Sensor may need to be adjusted, cleaned, or replaced: i. 25 – Door Unlocked (occurs during a cycle) ii.
  • Page 76 ii. If there is a larger gap than shown below, the adjustment screw needs to be slightly raised. Proceed to (d). Door Lock Sensor Actuator Door Lock Sensor Adjustment Screw PUSH d. Using a 3/32” hex key, remove the mounting screws and carefully slide the door lock mechanism off the hub, leaving the solenoid armature and linkage assembly accessible as shown below.
  • Page 77 Adjustment Screw Lock Nut NOTE: It is recommended to rotate the screw with 1/2 rotation increments for adjustments. g. Re-assemble the door lock mechanism to the hub and perform the following checks: i. Repeat step (c) and check the actuator gap. ii.
  • Page 78 a. The sensor is located at the 4 o’clock position on the door frame. Remove the right-side panel. b. Using a 13/16 wrench, loosen the jam nut on the sensor to allow the sensor to be adjusted. 13/16 jam nut Close the door.

  • Page 79: Solenoid Valve Maintenance

    8.5 Solenoid Valve Maintenance DIN Connector Loosen these 11/16 nuts SOLV-3, back view shown 1. Drain the sterilizer, turn the sterilizer OFF, and disconnect power. 2. If a solenoid valve is leaking or will not actuate, remove the valve from the sterilizer by disconnecting the electrical DIN connector with a Phillips screwdriver, disconnecting the two plumbing fittings with 11/16 wrenches, and if necessary, removing the two mounting screws from underneath the valve.

  • Page 80: Chamber Temperature Sensor Replacement

    8. Follow Section 5.4 for post-maintenance activities. FDI recommends completing three consecutive sterilization cycles with biological indicators in the load. NOTE: Temperature sensors are factory checked for accuracy and cannot be adjusted in the field. Contact FDI Technical Support for more information.

  • Page 81: Chamber Pressure Sensor Replacement

    Chamber Pressure is reading close to 0.0 psig with the door open. 8. Run an IUSS cycle and check for steam leaks. 9. Re-install the panels. 10. Follow Section 5.4 for post-maintenance activities. FDI recommends completing three consecutive sterilization cycles with biological indicators in the load.

  • Page 82: Software Update

    13. Reconnect the two connectors to the PCB boards. 14. Record the battery replacement in the maintenance log with the cycle count. 15. See Section 5.4 for post-maintenance activities. FDI recommends completing three consecutive sterilization cycles with biological indicators in the load to verify performance.

  • Page 83: Plc Replacement

    11. The PLC will restart, show the splash screens, and then the HOME screen will appear. 12. Turn the sterilizer OFF and remove the Micro SD card. 13. See Section 5.4 for post-maintenance activities. FDI recommends completing three consecutive sterilization cycles with biological indicators in the load to verify performance.
  • Page 84 22. Set all desired settings such as time, date, and UNIT ID on the SETUP screen. 23. Navigate to the STATUS screen and verify all inputs are reading correctly. 24. See Section 5.4 for post-maintenance activities. FDI recommends completing three consecutive sterilization cycles with biological indicators in the load to...

  • Page 85: Pressure And Temperature Sensor Check

    The pressure difference should 1.8 psi. If the accuracy check fails, re-run the procedure to verify the results. Replacement sensors can be sourced from FDI. See Section 5.3 for the replacement parts list. 12. Finish the calibration check by turning the sterilizer OFF, disconnecting power, and then following steps a) through e) in reverse order to remove the calibration device and return the sterilizer to its service-ready state.

  • Page 86: Troubleshooting

    9 Troubleshooting WARNING: Service and maintenance work must be performed by qualified personnel only. The FAULT screens will display a fault number and title that corresponds to Table 7. This table can be used to diagnose and perform necessary corrective actions to address the fault.
  • Page 87 Fault Description Corrective Action Check the CV-2 Check Valve, located behind the bottom panel. Check the Boiler Drain Valve (SOLV-1) Check the Boiler and Water Tank Level Sensors (LS-1 and LS-2). Allow sterilizer to cool. Navigate to the STATUS screen on the touchscreen controller.
  • Page 88 Fault Description Corrective Action technician verify the heaters (H- 1&2) and heater control relay (SSR-H1) are working correctly. Excessive electromagnetic interference. Relocate sterilizer if possible. Check RTD-1&2 by navigating to the STATUS screen and comparing Chamber Temperature 1 to 2. Troubleshoot High chamber Chamber and replace as needed.
  • Page 89 Fault Description Corrective Action Have a qualified maintenance technician verify the heaters (H- 1&2) and heater control relay (SSR-H1) are working correctly. Check RTD-1&2 by navigating to the STATUS screen and comparing Chamber Temperature 1 to 2. Troubleshoot and replace as needed. Heat up, stabilizing, and exposure Check for chamber steam leaks.
  • Page 90 Fault Description Corrective Action Inspect the check valves for leaks. Check the Air Out Valve (SOLV- 4) and associated plumbing. The sterilizer Heat exchanger could be exceeded expected clogged. Check operation by Drying Pressure chamber pressure navigating to SETUP and High during drying.
  • Page 91 Fault Description Corrective Action Inspect the RTD wire connectors to the PLC. These are the red Chamber temperature and white three-wire connections sensor contains a 2nd to the bottom of the PLC. Is sensing element to anything loose? check the control RTD Deviation sensor.
  • Page 92 Fault Description Corrective Action Ensure ambient temperature > 35°F (1.7°C). Remove the right-side panel and inspect RTD-1&2 wiring for loose wires, physical damage, RTD Out of RTD reading is <15°F. disconnections, etc. Range Remove the top panel and electrical enclosure and inspect the electronics enclosure RTD-3.
  • Page 93 (e.g., if a cycle was just run, Surface Heater Surface heaters are about 200-300°F). Overtemperature > 400°F. Inspect TC-3 to verify there is no damage. Contact FDI to diagnose and replace the surface heater. The surface heater is not field replaceable.

  • Page 94: Appendix

    APPENDIX...

  • Page 96: Limited Warranty

    STATUTE OF LIMITATIONS No action may be brought against FDI for breach of this limited warranty, an implied warranty, if any, or for any other claim arising out of or relating to the FRONT-LINE Field Sterilizer, more than ninety (90) days following expiration of the limited warranty period.

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