Apex Digital STURDY SA-300MB Instruction Manual
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Apex Digital STURDY SA-300MB Instruction Manual

Autoclave sterilizer
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SA-300MB / SA-302MB
Instruction Manual
Please read manual carefully before using and keep it well for future reference.

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Summary of Contents for Apex Digital STURDY SA-300MB

  • Page 1 SA-300MB / SA-302MB Instruction Manual Please read manual carefully before using and keep it well for future reference.

  • Page 2: Table Of Contents

    Contents 1. Important Safety Instructions ....................1 2. Explanation of Safety Symbols and Notes ................9 3. Unpacking ..........................10 4. Installation ..........................11 4.1 Environment ........................11 4.2 Set up ........................... 11 4.2.1 Waste out draining ....................12 4.2.2 Manual water ...................... 13 4.2.3 Connecting an external water supply system............
  • Page 3 6.11.5 Auto Add Water ....................76 6.11.6 Cycle Counter ....................78 6.11.7 Series Number ....................80 6.11.8 Calibration (Engineering Mode, Authorized Personnel Only) ......82 6.12 Description of Printer ....................84 6.12.1 Dimensions of Printer Paper ................84 6.12.2 Installation of Printer Paper ................84 6.12.2.1 Automatic Feeding Paper ...............
  • Page 4 10 Test Instructions ........................121 10.1 Biological performance of sterilizers ................. 121 10.2 Air removal (Bowie-Dick type test pack) ..............122 10.3 Helix test ........................124 11. Specifications ........................126...

  • Page 5: Important Safety Instructions

    1. Important Safety Instructions In order to clearly indicate the extent of the harm, loss or damage which may result from falling to heed these precautions and the degree of their urgency, the precaution have been classified into the three categories of Danger, Warning and Caution. Danger: This indicates an imminently hazardous situation arising from the mishandling or mis-operation of the unit which, if not avoided, might cause the death or serious injury of the operator or other persons.
  • Page 6 Warning: DO NOT place alcohol or other flammable items in the sterilizer. An explosion could occur, causing personal injury. Gasoline Alcohol Chemical…… Figure 2 Warning: A separate (dedicated) circuit is recommended for the sterilizer. The sterilizer should not be connected to an electrical circuit with other appliances or equipment.
  • Page 7 Figure 5 Warning: Do not put your fingers into the gap on the hinged side of the door. Figure 6 Warning: Always check the pressure gauge before opening the door. DO NOT attempt to open the door if the pressure is not at zero (0). Check Pressure at “ZERO”...
  • Page 8 Warning: In an emergency, or before carrying out any maintenance, always disconnect the power cord from the outlet. Figure 8 Warning: Use sterilization indicator test strips to check that sterilization has been successful. Figure 9 Warning: If the ALARM indicator light illuminates, the machine is over-pressure or overheated.
  • Page 9 Warning: Use only distilled water. Normal tap water contains minerals, especially chlorides, which have corrosive effects on stainless steel. Failure to use distilled water will invalidate the warranty. Pure Water City Water Groundwater …… Figure 11 Caution: Do not put objects on the power plug or power cord. Figure 12 Caution: The outer casing and metal surfaces of the sterilizer will be hot during operation, please do not touch it.
  • Page 10 Caution: Do not place objects on top of the water intake cap. Figure 14 Caution: Steam and hot water will be present when opening the door after a sterilizer cycle. Avoid contact. Figure 15 Caution: DO NOT place any objects on the top of the sterilizer. Figure 16...
  • Page 11 Caution: Do not tip over the unit or allow it to fall on the power plug. Figure 17 Caution: It will require at least two (2) or more people to carry the sterilizer to avoid dropping it off by mistake. Figure 18 Caution: Always allow a minimum of 20 min.
  • Page 12 Caution: Please unplug the power cord and drain off water from the reservoir if the sterilizer will not be used regularly. Drin hose Wide-mouthed container Figure 20 Caution: Always keep the sterilizer clean. Figure 21 WARNING: The door must be closed completely during operation of the unit. If the “Door open”...

  • Page 13: Explanation Of Safety Symbols And Notes

    2. Explanation of Safety Symbols and Notes Caution, consult instruction manual for use Protective earth (ground) Alternating Current Attention! Hot surface Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment.

  • Page 14: Unpacking

    3. Unpacking CAUTION: It will require at least two (2) or more people to carry the sterilizer to avoid dropping it off by mistake. Wall Base Figure 22 – Unpacking Cut the banding Lift off the top cover of the carton Remove the wall and the foam packaging inserts Carefully lift the sterilizer from the packaging base Check all accessories are present as follows (accessories are packed inside the sterilizer...

  • Page 15: Installation

    4. Installation 4.1 Environment This equipment has been designed for use in accordance with the International EMC (Electromagnetic Compatibility) Standards. In view of different environments, please follow the instructions given below to eliminate interference, if necessary. Move the equipment or rotate its direction; Enlarge the space between the equipment and other machines;...

  • Page 16: Waste Out Draining

    4.2.1 Waste out draining Heating water is drained from the chamber through this outlet located at the back of the sterilizer. Connect the exhaust hose to the “WASTE OUT” as shown in Figure 23 to drain heating water according to the local national law. WARNING: Examine that pipelines connected from “waste outlet”...

  • Page 17: Manual Water

    4.2.2 Manual water Open the water reservoir cap; pour water for sterilization or distilled water into the water reservoir as shown in Figure 25 Water Reservoir Cap Figure 25 WARNING: Do NOT fill water into the reservoir during the sterilization process to avoid overflow.
  • Page 18 How to set the” Auto add water”: Select ”system setting” as shown in Figure 27 (Refer to “6.8.4” for detail operation.) MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃ PRION LIQUID Customization Function Test System Setting Figure 27 and then select ” Auto add water” as shown in Figure 28. System set Date and Time Language...

  • Page 19: Installation

    4.3 Installation Install the heater cover to the chamber as shown in Figure 30 (standard accessory) Ensure the rounded edge is towards the back and the vertical front edge of the cover locates securely into the corresponding slots in the lower part of the chamber opening. Heater Cover Chamber Water Stopper...
  • Page 20 C. Install the tray as shown in Figure 32. (standard accessory) Tray Tray Frame Heater Cover Figure 32 – Tray D. Install the Sterilization Box as shown in Figure 33. (optional accessory) Sterilization Box Heater Cover Figure 33 – Sterilization Box Usable space in the chamber The chamber usable space is the maximum volume of the chamber for accommodating a sterilization load.
  • Page 21 ※ SA-300MB 206 x 203 x 500 mm (W x H x D); equal to the volume of 20.9 liters Figure 34 ※ SA-302MB 206 x 203 x 640 mm (W x H x D); equal to the volume of 26.7 liters Ensure the Power Switch is in OFF “O”...

  • Page 22: Introduction

    5. Introduction 5.1 Intended Use This product is a tabletop high pressure steam sterilizer which is designed and developed for the sterilization of wrapped and unwrapped items. Suitable loads are those included in EN 13060 such as solid, porous, hollow loads type A, hollow loads type B;...

  • Page 23: Definition Of Two Reservoir

    Maintenance Cover Ball Valve Power Cord Figure 37 – Bottom View 5.2.2 Definition of two reservoir The default position of this ball valve is set to “CLOSE” for separating of clean and waste water in the reservoir. Turn the valve to “OPEN” position if separation of clean and waste water is not required as shown in Figure 38.

  • Page 24: Internal Configuration

    5.2.3 Internal Configuration Temperature Sensor Over temperature controller Exhaust Heater Water Stopper Water Level Sensor Figure 39 – Inside of Chamber...

  • Page 25: Control Panel

    5.2.4 Control Panel 5.2.4.1 300MB / 302MB Control Panel LCD Panel: Display the information of sterilization status. Up button: Enter Button: Used for setting Press this button and changing the to execute or function and confirm the input increasing the data.

  • Page 26: Operation

    6. Operation The “Table 1” describes the build-in programs that can be used by the sterilizer model SA-300MB & SA-302MB. Cycle Program Description UNWRAPPED 121ºC Applicable to solid, porous, hollow loads type A, hollow loads type B; WARAPPED 121ºC both single wrapped and double wrapped, and unwrapped loads. UNWRAPPED WARAPPED Pre-Vacuum pulses(Times)
  • Page 27 Cycle Program Description LIQUID(Optional) Applicable to LIQUID load. This function allows the operator to define special sterilization cycle (such as temperature and time) within the specification of this autoclave. Sterilization temp: 105-135℃, Sterilization time: 1-60 minutes WARNING: Users who define the parameters should take their own responsibilities and obligations to undertaken the risk of sterilization uncertainty.
  • Page 28 Holding time (Sterilization) 121℃/134℃ 121°C or 134°C 119°C Exhaust Time Ambient Temp °C 0 bar -.0.35 bar -0.80 bar Pre-Vacuum Heating Up Drying Temp. / Pressure Figure 41 Legend of each cycle: Table 2 T0-T1，T2-T3，T4-T5， PV1- PV4 Vacuum stage (Air removal stage) T6-T7，T8-T9 T1-T2，T3-T4，T5-T6，...
  • Page 29 SA-300MB Maximum load of each build-in program: Table 3 Program Unwrapped Unwrapped Wrapped Wrapped 121ºC 134ºC 121ºC 134ºC Customization PRION LIQUID Pre-Vacuum No-Vacuum Temperature (ºC) 105-135 119-135 105-135 Pressure (bar) -0.8 Sterilization time(minutes) 1-60 Dry time (minutes) 1-60 Total time (minutes) 137-182 1-60 60-200...
  • Page 30 SA-302MB Maximum load of each build-in program: Table 4 Program Unwrapped Unwrapped Wrapped Wrapped Customization 121ºC 134ºC 121ºC 134ºC PRION LIQUID Pre-Vacuum No-Vacuum Temperature (ºC) 105-135 119-135 105-135 Pressure (bar) -0.8 Sterilization time(minutes) 1-60 Dry time (minutes) 1-60 Total time (minutes) 137-182 1-60 70-210...
  • Page 31 Function test program: Table 5 Test program Air leakage Helix B&D TEST TEST TEST Temperature (ºC) Pressure (bar) -0.8 Sterilization time (minutes) Dry time (minutes) Total time (minutes) Type of load Empty chamber Test tool...

  • Page 32: Flow Chart With Build-In Program

    6.1 Flow Chart with Build-in Program Locate the sterilization items and close door; insert a SD card. Test Program Standard Sterilization Program 1) Leakage Test 1) Unwrapped 121°C 2) Wrapped 121°C 2) Helix Test 3) Unwrapped 134°C 4) Wrapped 134°C 3) B&D Test 5) PRION Leakage Program...

  • Page 33: Flow Chart With Liquid Program (Optional)

    6.2 Flow Chart with LIQUID Program (Optional) Locate the sterilization items and close door; insert a SD card. LIQUID(Optional) Setting Sterilization Temp: 105-135 ºC Sterilization time:1- 60 min Press “Enter” Button to star vacuum Add Water and Heating Equilibrium Time Sterilization Cooling Down Cycle Complete...

  • Page 34: Flow Chart With Customization Program

    6.3 Flow Chart with Customization Program Locate the sterilization items and close door; insert a SD card. Customization Setting Dry only Without Pre-vacuum With Pre-vacuum Sterilization Temp: Sterilization Temp: Dry time: 105-135 °C 119-135°C 1-60 min Sterilization time: 1- 60 Sterilization time: 1- 60 min 59 seconds min 59 seconds...

  • Page 35: Prepare Sterilization

    6.4 Prepare Sterilization Follow “4.2 ” to finish installation first. Follow “4.2 ” to make sure the water inside reservoir is sufficient. C. Press the “POWER” switch to ON “I” position. D. Check the Pressure Gauge is reading ZERO, and then press the “unlock button” open the door latch shown in Figure 42.
  • Page 36 WARNING: The door must be closed completely during operation of the unit. If the “Door open” displayed, it means that the door is not closed properly. Figure 44 H. Insert a formatted SD card.

  • Page 37: Standard Sterilization Program

    6.5 Standard Sterilization Program Before start Sterilization program please refer to “6.3 Prepare Sterilization” section. How to set the Standard Sterilization program: Holding time (Sterilization) 121℃/134℃ 121°C or 134°C 119°C Exhaust Time Ambient Temp °C 0 bar -.0.35 bar -0.80 bar Drying Pre-Vacuum Heating Up...
  • Page 38 MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃ PRION LIQUID Customization Function Test System Setting Figure 47 Unwrapped 121℃ Pre-Vacuum Ster. Temp: 121℃ Ster. Time: 15 m00s DryTime:15m Figure 48 Wrapped 121℃ Pre-Vacuum Ster. Temp: 121℃ Ster. Time: 30m00s DryTime:30m Figure 49 D.
  • Page 39 Press button again to star the selected program. The relative information such as program cycle, present process, temperature, pressure and time as shown in Figure 50 or Figure 51 will be displayed on the panel. Program Unwrapped 121℃ Present Process:PV1 Process TC: 35.0℃...
  • Page 40 G. When press the button to open the door, a “Mind the Steam” will be prompted and then followed by “Please Open Door.” message. Open the door and take out the sterilized items. Check the status of the indicators. If failed, repeat the cycle. Consult with the qualified technician for calibration if necessary.

  • Page 41: Prion Sterilization Program

    6.6 PRION Sterilization Program Before start Sterilization program please refer to “6.4 Prepare Sterilization” section. How to set the PRION Sterilization program: Holding time (Sterilization) 121℃/134℃ 121°C or 134°C 119°C Exhaust Time Ambient Temp °C 0 bar -.0.35 bar -0.80 bar Drying Pre-Vacuum Heating Up...
  • Page 42 D. Parameters of the PRION programs: Table 7 PRION Sterilization Temperature (ºC) Sterilization Time (min.) Dry Time (min.) Press button again to star the selected program. The relative information such as program cycle, present process, temperature, pressure and time as shown in Figure 56 will be displayed on the panel.
  • Page 43 WARNING: Check the pressure gauge is reading ZERO before opening the door. WARNING: Beware of steam when opening door after a sterilization cycle. WARNING: Be careful when removing the sterilized items as the metal surfaces might still be hot. Always wear suitable hand protection to remove the box or use the appropriate aids (tray holder) to lift the trays.

  • Page 44: Liquid Program (Optional)

    6.7 LIQUID Program (Optional) WARNING: This is not a CE declared program and validation of sterility when using this program is the responsibility of the user. WARNING: Users who define the parameters should take their own responsibilities and obligations to undertaken the risk of sterilization uncertainty. Before start Sterilization program please refer to “6.4 Prepare Sterilization”...
  • Page 45 LIQUID Ster. Temp: 121℃ Ster. Time: 10m Start Figure 60 D. Press button to move the cursor to the “Ster. Temp”. Press button to enter editing mode, and then press button to change sterilization temperature. Press button to store sterilization temperature parameter as shown in Figure 61. LIQUID Sterilization Ster.
  • Page 46 Parameters of the customization programs: LIQUID 105 - 135 ℃ Range of Sterilization Temperature Range of Sterilization Time 1 - 60 minutes Table 8 G. Press button until as shown in Figure 63. LIQUID Ster. Temp: 121℃ Ster. Time: 10m Figure 63 H.
  • Page 47 When press the button to open the door, a “Mind the Steam” will be prompted and then followed by “Please Open Door.” message. Open the door and take out the sterilized items. Check the status of the indicators. If failed, repeat the cycle. Consult with the qualified technician for calibration if necessary.

  • Page 48: Dry Program

    6.8 Dry Program Before start Sterilization program please refer to “6.4 Prepare Sterilization” section. How to set the Dry program: Time 0 bar Ambient Temp℃ Vacuum Drying Figure 66 C. Press button to select Dry program cycle (Figure 67). MENU Unwrapped 121℃...
  • Page 49 Press button to move the cursor to the “Start” (Figure 69), change the dry time, and then press button to confirm dry time, as shown in Figure 70. Dry Time： 10 m Start Figure 69 Dry Time： 10 m Figure 70 Parameters of the Dry programs: Table 9 Sterilization Temperature (ºC)
  • Page 50 H. On completion, the buzzer will sound and the Program Complete message is displayed as shown in Figure 72. Program Complete Sterilization: Finish TC: 85.0℃ Pres.: -0.002bar Total Time: 65m04s Figure 72 – Program Complete WARNING: If any messages prompt, you may need to repeat the dry cycle. When press the button to open the door, a “Mind the Steam”...

  • Page 51: Customization Program

    6.9 Customization Program WARNING: This is not a CE declared program and validation of sterility when using this program is the responsibility of the user. WARNING: Users who define the parameters should take their own responsibilities and obligations to undertaken the risk of sterilization uncertainty. 6.9.1 Customization with pre-vacuum Before start Sterilization program please refer to “6.4 Prepare Sterilization”...
  • Page 52 Customization Selection of Pre-vacuum Pre-Vacuum：YES Sterilization Temperature Ster.Temp： 135 ℃ Sterilization Time Ster.Time：60 m 10 s Dry Time： 60 m Dry Time Figure 75 D. Press button to enter editing mode, and then press button to select “Yes” or “No”. Press button to store Pre-Vacuum parameter as shown in Figure 76.
  • Page 53 Customization Pre-Vacuum：YES Ster.Temp： 135 ℃ Sterilization Ster.Time：60 m 10 s Time (min) Dry Time： 60 m Figure 78 G. Press button to move the cursor to the “Ster. Time”. Press button to enter editing mode, and then press button to change sterilization time- seconds.
  • Page 54 Parameters of the customization programs: Customization Pre-vacuum Range of Sterilization Temperature (ºC) 119 - 135 Range of Sterilization Time 0 - 60 minutes 59 seconds Range of Dry Time (min.) 0 - 60 Table 10 Press button until as shown in Figure 81. Customization Pre-Vacuum Ster.Temp：...
  • Page 55 On completion, the buzzer will sound and the Program Complete message is displayed as shown in Figure 83. Program Complete Sterilization: Finish TC: 85.0℃ Pres.: -0.002bar Total Time: 65m04s Figure 83– Program Complete WARNING: If any messages prompt, you may need to repeat the sterilization cycle. M.

  • Page 56: Customization Without Pre-Vacuum

    6.9.2 Customization without pre-vacuum Before start Sterilization program please refer to “6.4 Prepare Sterilization” section. How to set the customization without pre-vacuum program: Holding time (Sterilization) 121°C or 134°C 121℃/134℃ 119°C Exhaust Time Ambient Temp °C 0 bar -.0.35 bar Pre-Vacuum -0.80 bar Heating Up...
  • Page 57 Customization Selection of Pre-vacuum Pre-Vacuum：YES Sterilization Temperature Ster.Temp： 135 ℃ Sterilization Time Ster.Time：60 m 10 s Dry Time Dry Time： 60 m Figure 86 D. Press button to enter editing mode, and then press button to select “Yes” or “No”. Press button to store Pre-Vacuum parameter as shown in Figure 87.
  • Page 58 Customization Pre-Vacuum：NO Ster.Temp： 135 ℃ Sterilization Ster.Time：60 m 10 s Time (min) Dry Time： 60 m Figure 89 G. Press button to move the cursor to the “Ster. Time”. Press button to enter editing mode, and then press button to change sterilization time- seconds.
  • Page 59 Parameters of the customization programs: Table 11 Customization Pre-vacuum Range of Sterilization Temperature ( ºC) 105 - 135 Range of Sterilization Time 0 - 60 minutes 59 seconds Range of Dry Time ( min ) 0 - 60 Press button until as shown in Figure 92. Customization Pre-Vacuum Ster.Temp：...
  • Page 60 On completion, the buzzer will sound and the Program Complete message is displayed as shown in Figure 94. Program Complete Sterilization: Finish TC: 85.0℃ Pres.: -0.002bar Total Time: 65m04s Figure 94– Program Complete WARNING: If any messages prompt, you may need to repeat the sterilization cycle. M.

  • Page 61: Function Test Program

    6.10 Function Test Program There are 3 built-in test programs for checking the basic performance of the sterilizer as following. 6.10.1 Leakage Test The leakage test is used to demonstrate that the quantity of air leakage into the sterilizer chamber during the periods of vacuum does not exceed a level which will inhibit the penetration of steam into the sterilizer load and will not be a potential cause of re-contamination of the sterilizer load during drying.
  • Page 62 MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃ PRION LIQUID Customization Function Test System Setting Figure 96 Function test Leakage test Helix test B&D test Figure 97 C. Press button to confirm the selection of Leakage Test Program, as shown in Figure Leakage test Pressure：-80kPa Time：...
  • Page 63 On completion, the buzzer will sound and the Program Complete message is displayed as shown in Figure 100. Program Complete Leakage Test： PASS Leakage Rate： 0.01 Total Time： 17m 12s Figure 100- Program Complete WARNING: Check the pressure gauge is reading ZERO before opening the door. WARNING: If using the sterilizer continuously, it’s required to have a 20 min.

  • Page 64: Helix Test

    6.10.2 Helix Test WARNING: This program is running at under 1,000m altitude. Before start Sterilization program please refer to “6.4 Prepare Sterilization” section. Please refer to “(Helix test)” and follow the test tool supplier’s instructions. C. How to set the Helix test program: Press button to select Function Test program (Figure 101), and then press button to confirm, as shown in Figure 102.
  • Page 65 D. Press button to select Helix Test program (Figure 103). Function test Leakage test Helix test B&D test Figure 103 Press button to confirm the selection of Helix Test Program, as shown in Figure 104. Helix Test Pre-Vacuum Ster. Temp：134℃ Ster.
  • Page 66 H. When press the button to open the door, a “Mind the Steam” will be prompted and then followed by “Please Open Door.” message. Open the door and take out the Helix load. Check the status of the indicators. If failed, repeat the cycle. Consult with the qualified technician for calibration if necessary.

  • Page 67: B&D Test

    6.10.3 B&D Test WARNING: This program is running at under 1,000m altitude. Before start Sterilization program please refer to “6.4 Prepare Sterilization” section. Please refer to “(B &D Test)” and follow the B&D supplier’s instructions. C. How to set the B&D test program: Press button to select Function Test program (Figure 107), and then press button to confirm, as shown in Figure 108.
  • Page 68 D. Press button to select B&D Test program (Figure 109). Function test Leakage test Helix test B&D test Figure 109 Press button to confirm the selection of B&D Test Program, as shown in Figure 110. B&D Test Pre-Vacuum Ster. Temp：134℃ Ster.
  • Page 69 H. When press the button to open the door, a “Mind the Steam” will be prompted and then followed by “Please Open Door.” message. Open the door and take out the Helix load. Check the status of the indicators. If failed, repeat the cycle. Consult with the qualified technician for calibration if necessary.

  • Page 70: System Setup

    6.11 System Setup 6.11.1 Date and Time Press button to select System Setting program (Figure 113), and then press button to select Date &Time setting, as shown in Figure 114. MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃ PRION LIQUID Customization Function Test...
  • Page 71 Press button to the editing mode as shown in Figure 115. Press button to change the Month. Press button to store the parameter. Date and Time Date=MMM/DD/YYYY Oct / 15 / 2015 Time=hh：mm：ss 16：35：20 Figure 115 C. Press button to shift the cursor to date. Press button to change the contents, and press button to store the parameter as shown in Figure 116.
  • Page 72 Press button to shift the cursor to hour. Press button to change the contents, and press button to store the parameter in Figure 118. Date and Time Date=MMM/DD/YYYY Oct / 15 / 2015 Time=hh：mm：ss 16：35：20 Figure 118 Press button to shift the cursor to minute. Press button to change the contents, and press button to store the parameter in Figure 119.
  • Page 73 H. Press button returns to System setting. System set Date and Time Language Unit Print Auto add Water Cycle counter Serial Number Calibration Figure 121...

  • Page 74: Language

    6.11.2 Language On the system setting page shown in Figure 122, move the cursor to column “Language” with button shown in Figure 123, and then press button to enter into the language setting. MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃...
  • Page 75 Figure 124 3. Press button and return to the System Setting page shown in Figure 125. MENU Unwrapped 121℃ Wrapped 121℃ Unwrapped 134℃ Wrapped 134℃ PRION LIQUID Customization Function Test System Setting Figure 125...

  • Page 76: Units

    6.11.3 Units Temperature unit and pressure unit are set to ºC and bar respectively as default; however, you can change these units as following: Temperature unit: ºC, ℉ Pressure unit: bar, kPa, MPa, psi, kgf/cm To change the unit: Press button to select System Setting program (Figure 126), and then press button to select Unit setting, as shown in Figure 127.
  • Page 77 Press button to the editing mode as shown in Figure 128. Unit Temp: ℃ Pressure：bar Figure 128 C. Press button to change the unit, and press button to store the parameter in Figure 129. Unit Temp: ℉ Pressure：bar Figure 129 D.

  • Page 78: Printer

    6.11.4 Printer The real time program steps could be printed by the printer and also stored on a SD memory. The values of the sterilization steps are used as a reference record of each sterilization process. It is set to “ON” as default. However, you may enable or disable the printer as following: Press button to select System Setting program (Figure 132), and then press...
  • Page 79 Press button to the editing mode as shown in Figure 134. Print Real Time output Figure 134 C. Press button to enable or disable the real time printout, and press button to store the parameter in Figure 135. Print Real Time output Figure 135 D.

  • Page 80: Auto Add Water

    6.11.5 Auto Add Water When the Auto Add Water is set to "ON" and start the sterilization program, it will check the water level of the water tank automatically. If water level of the water tank is not sufficient for running a sterilization cycle, it will supply the external water into the water tank until full level is reached.
  • Page 81 Press button to the editing mode as shown in Figure 139. Auto add Water Auto add Water Figure 139 C. Press button to enable or disable the Auto add water, and press button to store the parameter in Figure 140. Auto add Water Auto add Water Figure 140...

  • Page 82: Cycle Counter

    6.11.6 Cycle Counter The autoclave required to be inspected and examined after pre-determinate cycles (default value 5,000 cycles) for its safety and performance by qualified persons. A “Maintenance service” will be displayed to remind operator for the servicing work. Press any key to ignore the message.
  • Page 83 Press button to the editing mode as shown in Figure 144. Cycle Counter Current： 500 times Present cycle (shown 500 Next Service： times as an example) 5000 times Next Service Cycles：5000 Figure 144 C. Press button to change next service times, and press button to store the parameter in Figure 145.

  • Page 84: Series Number

    6.11.7 Series Number NOTE: The 12 digits series number, compose by 9 digits followed by a dash “–“and 3 digits, is the unique identification of each autoclave, which is factory default. To view the series number: Press button to select System Setting program (Figure 147), and then press button to view the Series Number, as shown in Figure 148.
  • Page 85 Press button to the viewing mode as shown in Figure 149. Date and Time SN：141005204-001 Figure 149 C. Press button returns to System setting. System set Date and Time Language Unit Print Auto add Water Cycle counter Serial Number Calibration Figure 150...

  • Page 86: Calibration (Engineering Mode, Authorized Personnel Only)

    6.11.8 Calibration (Engineering Mode, Authorized Personnel Only) CAUTION: This autoclave had been calibrated before shipment, and this Calibration function is password protected to prevent improper operation by the user. Only well-trained personnel can perform the calibration work. Failure to do calibration could result in serious injury or damage to the autoclave.
  • Page 87 Press button to the editing mode as shown in Figure 153. Calibration Pass Word： 4 digits 0000 Figure 153 C. Press button returns to System setting. System set Date and Time Language Unit Print Auto add Water Cycle counter Serial Number Calibration Figure 154...

  • Page 88: Description Of Printer

    6.12 Description of Printer 6.12.1 Dimensions of Printer Paper Thermal printer is installed in this sterilizer, and the dimension of thermal printer paper is 57 mm in wide, 50 mm in outside diameter, and 12 meter in length. 6.12.2 Installation of Printer Paper There are two ways for feeding paper, one is automatic feeding and the other is manual feeding.
  • Page 89 Lever Compartment of printer paper Figure 156 D. Replace with a new one thermal paper in the compartment, and position the lever in the “downward position” as shown in Figure 158. Locate the thermal paper near to the sensing inlet (Figure 157), the thermal paper will be detected and then fed automatically (See Figure 158) NOTE: Refer to the instruction of the thermal paper supplier for the printing face.
  • Page 90 Align the thermal paper matching with the paper outlet of the printer cover. Close the printer cover to complete the replacement. Figure 159...

  • Page 91: Manual Feeding Paper

    6.12.2.2 Manual Feeding Paper Turn on the Power. (Not necessary for manual replacement) Press down and then pull outward the rim of the printer cover (See Figure 160). Press down and then pull outward Paper outlet Figure 160 C. Take out the empty roll from the compartment (See Figure 161), and replace with a new one. In order to print correctly, please load the thermal paper according to the instruction of the thermal paper for the printing side.
  • Page 92 D. Position the lever in the “upward position” as shown in Figure 162. Lever upward Figure 162 Replace with a new one thermal paper in the compartment, and. Locate the thermal paper to the paper inlet as shown in Figure 163, and then push the thermal paper until you can pull it out.
  • Page 93 Align the thermal paper matching with the paper outlet of the printer cover. Close the printer cover to complete the replacement. Figure 165...

  • Page 94: Printout Of Printer

    6.12.3 Printout of Printer There are three types of printout as following: 1) General Program, 2) LIQUID Program (Optional), 3) Dry Program, 4) Leakage Test 6.12.3.1 Printout of General Program The following printout is applicable to programs of Unwrapped 121 ºC, Wrapped 121 ºC, Unwrapped 134 ºC, Wrapped 134 ºC, Customization, Helix test, and B &D test.
  • Page 95 Printer output Description end of recording Ster. Temp ： 135.0 - 135.8 ºC The maximum and minimum temperature detected during sterilization period The maximum and minimum pressure Ster. Pres ： 2.123 – 2.160 bar detected during sterilization period Sterilization period Ster.

  • Page 96: Printout Of Liquid Program (Optional)

    6.12.3.2 Printout of LIQUID Program (Optional) The following printout is applicable to programs of LIQUID. Table 14 Printer output Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program selected Program： LIQUID Sterilization temperature Ster.

  • Page 97: Printout Of Dry Program

    6.12.3.3 Printout of Dry Program The following printout is applicable to Dry Program: Table 15 Printer output Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program： Program selected Date：Apr.02.2015 Date and Time of sterilization Time：14：10：27 Cycle Counter ：000351 Cycles that had been started...

  • Page 98: Printout Of Leakage Test

    6.12.3.4 Printout of Leakage Test The following printout is applicable to Leakage Test: Table 16 Printer output Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program： Program selected Leakage Test Date：Apr.02.2015 Date and Time of sterilization Time：14：10：27 Cycle Counter ：000351 Cycles that had been started...

  • Page 99: External Storage Medium - Sd Card

    6.13 External storage medium – SD Card 6.13.1 Using a SD card The sterilization temperature, steam pressure and real time information during each cycle can be stored to an onto a SD memory card (hereinafter referred to as SD card) automatically if a SD card is inserted.

  • Page 100: Readout Of A Sd Card

    6.13.2 Readout of a SD card There are three types of readout as following: 1) General Program, 2) LIQUID Program (Optional), 3) Dry Program, 4) Leakage Test 6.13.2.1 Readout of General Program The following readout is applicable to programs of Unwrapped 134 ºC, Wrapped 134 ºC, Unwrapped 121 ºC, Wrapped 121 ºC, Customization, Helix test, and B &D test.
  • Page 101 Readout of a SD card Description The maximum and minimum temperature Ster. Temp ： 135.0 – 135.8 ºC detected during sterilization period The maximum and minimum pressure Ster. Pres ： 2.123 – 2.160 bar detected during sterilization period Ster. Time ： 4 m 0 s Sterilization period Total time...

  • Page 102: Readout Of Liquid Program (Optional)

    6.13.2.2 Readout of LIQUID Program (Optional) The following printout is applicable to programs of LIQUID. Table 18 Readout of a SD card Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program selected Program： LIQUID Sterilization temperature Ster.

  • Page 103: Readout Of Dry Program

    6.13.2.3 Readout of Dry Program The following readout is applicable to Dry Program: Table 19 Readout of a SD card Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program： Program selected Date：Apr.02.2015 14：10：27 Date and Time of sterilization Cycle Counter ：000464 Cycles that had been started...

  • Page 104: Readout Of Leakage Test

    6.13.2.4 Readout of Leakage Test The following readout is applicable to Leakage Test: Table 20 Readout of a SD card Description Model number Model：SA-300MB Ver. Software version installed in this autoclave SA-300MB_A1V2.0 SN：141005204-001 Series number Program： Program selected Leakage Test Date：Apr.02.2015 14：10：27 Date and Time of sterilization...

  • Page 105: Emergency Stop

    6.14 Emergency Stop Press the Emergency Button to interrupt the program and release the pressure inside the chamber. The sterilizer will sound to alert, and the message “Emergency stop” will be displayed to notify an emergency operation. Please wait till the pressure gauge is reading ZERO, WARNING: The Emergency Button can only been pressed when there’s an unusual event or emergency.

  • Page 106: Placement For Items To Be Sterilized

    6.15 Placement for items to be sterilized Please place items to be sterilized on the tray properly in order to have the best drying result. WARNING: To sterilize absorbent cotton or woolen, please wrap it with sterilizing pouch to avoid piping clog. 6.15.1 Sterilization for Implements Place implements on the tray evenly according to Figure 166.
  • Page 107 WARNING: We suggest using Spring Holder for items with sterilizing pouches to assure sterilization result. Follow Figure 169 or Figure 170 to place each pouch separately. Spring holder is available as an optional accessory. Figure 169 Figure 170...
  • Page 108 WARNING: If implements are packed with sterilizing pouches and placed inside sterilization box, make sure to display items as shown in Figure 171. Figure 171...

  • Page 109: Sterilization For Wrap

    6.15.2 Sterilization for Wrap WARNING: To sterilize absorbent cotton or woolen, please wrap it with a thin towel, covering cloth, linen, or sterilizing pouch to avoid piping clog according to Figure 172. Figure 172 Place wrap upright on the tray. Be careful not to let wrap touching the inner side of chamber.

  • Page 110: Placement For Sterilization Box

    6.15.3 Placement for Sterilization box Insert chemical indicator into wrap, then place wrap inside the sterilization box. Be sure there will be enough space between each wrap for better air flow. Make sure to close the cover of sterilization box properly. Figure 173 WARNING: Please follow above Figure 173 and place wrap vertically inside the...

  • Page 111: Messages And Troubleshooting

    7 Messages and Troubleshooting 7.1 System Message Code Message Description and Solution Emergency stop 1) The EMERGENCY button was pressed to interrupt the program. Please wait until the pressure been release to 0 reading and then pressure the “unlock button” open the door by turning the door knob 90°...

  • Page 112: Component Message

    7.2 Component Message Code Message Description and Solution SSR1 fault 1) SSR1 fault, press any key to terminate operation. 2) Consult your service agent. SSR2 fault 1) SSR2 fault, press any key to terminate operation. 2) Consult your service agent. Absolute 1) Pressure gauge P1 fault;...

  • Page 113: Process Message

    7.3 Process Message Code Message Description and Solution Altitude over 1) Sea level above 2000M detected, press any key to terminate operation. 2) Consult your service agent. Room temp too 1) Room temperature lowers than 5ºC, press any key to terminate operation.
  • Page 114 Code Message Description and Solution Low temp 1) The sterilization temperature lower than preset value during during Sterilizer sterilization step, press any key to terminate operation. step 2) Consult your service agent. Temp rise too 1) The sterilization temperature higher than preset value, 8°K/min, fast before sterilization step, press any key to terminate operation.

  • Page 115: Test Message

    7.4 Test Message Code Message Description and Solution Leakage fail 1) The rate of air leakage into the chamber during periods of vacuum exceed 0,13 kPa/min. 2) Consult your service agent. Chamber temp 1) The chamber temperature higher than 40ºC, press any key to higher than 40 terminate operation.

  • Page 116: Storage Medium Message

    7.5 Storage Medium Message Code Message Description and Solution EEPROM error 1) EEPROM writes error, press any key to terminate operation. 2) Consult your service agent. No SD card 1) SD card write error or write protected, press any key to terminate operation.

  • Page 117: General Troubleshooting

    7.6 General Troubleshooting Symptoms Possible Cause Solution The main cable is Plug in the sterilizer and turn on the socket unplugged or the switch. socket switch is off. Main switch not turn Press the Power switch to ON ”I” position. LCD not Wait until the sterilizer cool down to room Illuminated...

  • Page 118: Maintenance Instructions

    8. Maintenance Instructions WARNING: Failure to follow the Maintenance Instructions will adversely affect performance and lifespan of the sterilizer, and may invalidate the warranty. WARNING: Before conducting maintenance, please turn off the sterilizer and disconnect from the power supply. Check the sterilizer has cooled down to room temperature.
  • Page 119 CAUTION: Place a towel underneath the filter tap to avoid leakage. Counterclockwise Filter Nut Towel Figure 174 Take out the filter following the direction of the arrow. Figure 175 Take out the filter carefully, and flush it with water to clean it. Assemble it back as shown in Figure 176.

  • Page 120: Monthly Maintenance

    8.3 Monthly Maintenance Use the non-corrosive cleaner and stiff bristled brush or sponge to clean the water level sensor at the rear of the chamber as shown in Figure 177. CAUTION: Clean the dirt off from the sides of the sensor is more important than the tip. Use a damp cloth to wipe the surface after cleaning.
  • Page 121 Check if the Air Filter too dirty. Air Filter Figure 179 Open the door and visual inspect if the Air Filter become dark-grey. Replace with a new Air Filter (HEPA) with the same part number. WARNING: If excessive force is required to pull the safety valve, it must be replaced. Call for service.

  • Page 122: Annually Maintenance

    8.4 Annually Maintenance CAUTION: An annual maintenance service by a trained engineer is necessary. Contact your distributor for details. The following maintenance instructions are for your reference only. Calibrate the temperature and pressure during sterilization process. (Use biological indicators to test the validity of sterilization) Check if there’s any leakage of the piping.
  • Page 123 3. Install the gasket with the door gasket frame, door gasket plate inside to the door groove. Press the gasket into the door groove evenly as shown in Figure 182. Take thick end of silicone door gasket of the installation direction while pressing the gasket into the groove. Refer to Figure 183 for the correct direction.

  • Page 124: Water Quality

    9 Water Quality Suggested maximum limits of contaminants in and specification for water for steam sterilization: Table 21 CAUTION: We recommend testing the water quality once a month. The use of water for autoclaves that does not comply with the table above may have severe impact on the working life of the sterilizer and can invalidate the manufacturer’s guarantee.

  • Page 125: Test Instructions

    10 Test Instructions 10.1 Biological performance of sterilizers It is commonly used as a challenge organism for sterilization validation studies and periodic check of sterilization cycles. The biological indicator contains spores of the organism on filter paper inside a vial. After sterilizing, the cap is closed, an ampoule of growth medium inside of the vial is crushed and the whole vial is incubated.

  • Page 126: Air Removal (Bowie-Dick Type Test Pack)

    10.2 Air removal (Bowie-Dick type test pack) A commercially available Bowie-Dick type test pack that is of a size appropriate to the chamber being tested. The indicator is a heat sensitive sheet that is placed in the middle of a packet made up of various layers of paper and foam rubber.
  • Page 127 4. After processing, wear heat-resistant glover to remove the Cube from the sterilizer and allow to cool. WARNING: The metal clamp is hot at this stage of test. 5. Unlock the swing-bar and remove the indicator sheet from the center of the Cube. 6.

  • Page 128: Helix Test

    10.3 Helix test The Helix test represents a hollow A-type load (Conforms to EN 867-5 of tool), i.e. the load with the most critical characteristics. Carry out the test as follows (Example of TST LOADCHEK OF BROWNE): The Browne TST Control Helix is a Hollow Load Process Challenge Device (PCD) and has been developed and validated for testing the air removal (steam penetration) capability of small Type B steam sterilizers.
  • Page 129 WARNING: The HELIX Test will be very hot! 6. Open the capsule and remove the test strip. 7. More detail information please ask your dealer of HELIX test. 8. The result is as follows: Incorrect result: Figure 187 Incorrect result: Figure 188 Correct result: Figure 189...

  • Page 130: Specifications

    11. Specifications Model SA-300MB SA-302MB Chamber Capacity (L) Maximum Instrument Length (mm) Maximum Load (unwrapped, solid) (g) 10,000 12,000 Maximum Load (wrapped) (g) 2,400 3,000 External Dimensions (mm) 600 (W) ×485 (H) × 790 (D) 600 (W) ×485 (H) × 885 (D) Chamber Size (mm) 300 Diameter ×...
  • Page 131 WARRANTY Your “STURDY” product has a one (1) year guarantee of defective in materials and workmanship under normal use from the date of purchase. This warranty does not apply to any product damaged by accident‚ misuse, abuse‚ neglect‚ improper line voltage‚ drop‚ fire‚ flood. Or the products were altered or repaired by anyone other than qualified service personnel.
  • Page 132 Name Sturdy Autoclave Sterilizer Model SA-300MB/SA-302MB Manufacturer Sturdy Industrial Co. Ltd. Address No. 168, Sec. 1, Zhongxing Rd., Wugu District, New Taipei City, 24872, Taiwan APEX MEDICAL S.L. EC Representative Elcano 9, 6 ª planta 48008 Bilbao. Vizcaya SPAIN 422-03037-07...

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