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Apex Digital STURDY SA-230MA-R Instruction Manual

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SA-230MA-R
Instruction Manual
Please read manual carefully before using and keep it well.

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Summary of Contents for Apex Digital STURDY SA-230MA-R

  • Page 1 “ ” “ ” SA-230MA-R Instruction Manual Please read manual carefully before using and keep it well.

  • Page 2: Table Of Contents

    Contents 1. Important Safety Instructions ....................1 2. Explanation of Safety Symbols and Notes ................10 3. Unpacking ..........................11 4. Installation ..........................12 4.1 Environment ........................12 4.2 Install the sterilizer ......................12 5. Introduction ..........................17 5.1 Intended Use ........................ 17 5.2 Description of the Sterilizer ...................
  • Page 3 7.1 Intended use ......................... 43 7.2 Recording contents ....................... 43 7.2.1 Description of Detail Content ................44 7.2.2 Description of Summary Contents ..............45 7.3 Storage medium ......................47 7.4 Recorder panel ......................48 7.5 Function description of the recorder ................48 7.5.1 General .......................

  • Page 4: 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 5 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 6 WARNING: Children are not allowed to use or play with the unit. 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).
  • Page 7 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 8 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 9 CAUTION: Do not place objects on top of the water intake cap. Figure 14 CAUTION: Always check the water level in the reservoir before running a sterilization cycle. If the LOW WATER indicator light illuminates, add distilled water. If the water is sufficient, but the LOW WATER indicator light is still illuminating, refer to Troubleshooting.
  • Page 10 CAUTION: The ADD WATER indicator light will illuminate during the sterilization cycle. This is part of normal operation and no action on the part of the user is required. Figure 17 CAUTION: Steam and hot water will be present when opening the door after a sterilizer cycle.
  • Page 11 CAUTION: Do not tip over the unit or allow it to fall on the power plug. Figure 20 CAUTION: It takes at least two (2) or more people to carry the sterilizer to prevent it from dropping. Figure 21 CAUTION: Always allow a minimum of 20 min. between each sterilization cycle. Let me cool off for at least 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. Figure 23 CAUTION: Always keep the sterilizer clean. Figure 24...

  • 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 takes at least two (2) or more people to carry the sterilizer to prevent it from dropping. Wall Base Figure 25 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 chamber):...

  • 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 Open the water reservoir cap; pour distilled water into the water reservoir as Figure 26. Water Reservoir Cap Water Level Figure 26 CAUTION: Please fill Distilled Water Only into the unit. Please do not fill water over the yellow water level mark as Figure 27 and Figure 32. Yellow Water level Mark Water Level Figure 27...
  • Page 17 Install the heater cover to the chamber as Figure 28 (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 18 D. Install the tray frame as Figure 30 (optional accessory). CAUTION: The frame should be installed as Figure 30 below. The indention of the frame will pass the bushing in the chamber. Tray Frame Indention Figure 30 Install the tray as Figure 31. (optional accessory) Tray Frame Tray Heater Cover...
  • Page 19 G. Ensure the Power Switch is in OFF “O” position, and then plug the power cord into a separate (dedicated) mains socket. WARNING: A separate (dedicated) socket is required for the sterilizer. Make sure the socket is earthed and can offer the capacity of 16 A / 230V AC. WARNING: The plug is one of the measures of emergency cutoff;...

  • Page 20: 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. It can also perform sterilization of liquid which is not for medical purpose*. (*Liquid, Flash program and recorder are optional by order.) 5.2 Description of the Sterilizer 5.2.1 External View...

  • Page 21: Internal Configuration

    Maintenance Cover Exhaust Hose / Water Level Indicator Power Cord Figure 34 5.2.2 Internal Configuration Temperature Sensor Pressure Sensor Heater Over temperature controller Water Level Sensor Water Stopper Figure 35...

  • Page 22: Control Panel (Re-Dry Program)

    5.2.3 Control Panel (Re-Dry Program) 898-64012-01 Temperature Panel Display the temperature Visual Alarm Indicator Light inside the chamber. Indicates over-temperature or Display “REC” with recorder type (optional). over-pressure in the chamber Process Status Indicator Individual LED light to Low Water Indicator Light indicate the current status Indicates the water level is of the sterilization...

  • Page 23: Control Panel (Liquid Program) / (Optional By Order Request)

    5.2.4 Control Panel (Liquid Program) / (Optional by order request) Temperature Panel Display the temperature Visual Alarm Indicator Light inside the chamber. Indicates over-temperature or Display “REC” with recorder type (optional). over-pressure in the chamber Process Status Indicator Individual LED light to Low Water Indicator Light indicate the current status Indicates the water level is...

  • Page 24: Control Panel (Flash Program) / (Optional By Order Request)

    5.2.5 Control Panel (Flash Program) / (Optional by order request) Temperature Panel Display the temperature Visual Alarm Indicator Light inside the chamber. Indicates over-temperature or Display “REC” with recorder type (optional). over-pressure in the chamber Process Status Indicator Individual LED light to Low Water Indicator Light indicate the current status Indicates the water level is...

  • Page 25: Operation

    6. Operation 6.1 Operation Overview 6.1.1 Re-Dry Program Put the sterilization items and close door Standard Sterilization Program Select Sterilization Temp.121°C or 134°C Select Re-Dry Button Select Sterilization Item Select Dry/No Dry 0/15/30/35/40 min. Press “START” Button Vacuum, Add Water and Heat Re-Dry (10 min.) Repeat Vacuum and Heat steps for 4 times, and then...

  • Page 26: Liquid Program (Not Ce Marked)

    6.1.2 Liquid Program (Not CE marked) Put the sterilization items and close door Standard Sterilization Program Select Sterilization Temp.121°C or 134°C Select Liquid Program Select Sterilization Item Button Select Dry/No Dry 0/15/30/35/40 min. Press “START” Button Vacuum, Add Water and Heat Liquid Program Heat to Sterilization Repeat Vacuum and Heat steps for 4 times, and then...

  • Page 27: Flash Program (Not Ce Marked)

    6.1.3 Flash Program (Not CE marked) Put the sterilization items and close door Standard Sterilization Program Select Select Sterilization Temp.121°C or 134°C Flash Program Select Sterilization Item Button Select Dry/No Dry 0/15/30/35/40 min Press “START” Button Vacuum, Add Water and Heat Flash Program Repeat Vacuum and Heat steps for 4 times, and then Heat to Sterilization...

  • Page 28: Pump Test / Bd Test / Prion

    6.1.4 PUMP test / BD test / PRION Put the sterilization items and close door B.D. test, PRION Pump Test Press “START” Button Vacuum, Add Water and Heat Vacuum (10 min) Repeat Vacuum and Heat steps for 4 times, and then Heat to Selected Sterilization Temperature.

  • Page 29: Prepare Sterilization

    6.2 Prepare Sterilization Follow “4. Installation” to finish installation first. Follow “4.2 Install the sterilizer” to make sure the water inside reservoir is sufficient. C. Check the Pressure Gauge is reading ZERO, and then open the door by turning the door knob 90°...

  • Page 30: Standard Sterilization Program

    6.3 Standard Sterilization Program Before start Sterilization program please refer to “6.2 Prepare Sterilization” section. How to set the Standard Sterilization program 121°C or 134°C 120°C 0 bar (kgf/cm 103°C (Room Temp., °C) (Vacuum) Figure 41 C. Press “STERI TEMP” to select 121°C or 134°C D.

  • Page 31: Re-Dry Program (Exclusive Either To Liquid Or Flash Functions)

    On completion, the buzzer will sound same time the display will flash. The program has finished when the buzzer STOPS and the COMPLETE indicator light is illuminated on the Process Status Indicator. WARNING: If the COMPLETE indicator light was not lit, the cycle has failed and should be run again.

  • Page 32: Liquid Program (Optional, Exclusive Either To Re-Dry Or Flash Function)

    6.5 Liquid Program (optional, exclusive either to Re-Dry or Flash function) Before start Sterilization program please refer to “6.2 Prepare Sterilization” section. How to set the Liquid program 121°C (Room Temp., °C) 0 bar (kgf/cm Figure 44 Caution: After the sterilization step finished, the unit will take to exhaust spontaneously.
  • Page 33 On completion, the buzzer will sound same time the display will flash. The program has finished when the buzzer STOPS and the COMPLETE indicator light is illuminated on the Process Status Indicator. WARNING: If the COMPLETE indicator light was not lit, the cycle has failed and should be run again.

  • Page 34: Flash Program (Optional, Exclusive Either To Re-Dry Or Liquid Function)

    6.6 Flash Program (optional, exclusive either to Re-Dry or Liquid function) Before start Sterilization program please refer to “6.2 Prepare Sterilization” section. How to set the Flash program 134°C 0 bar (kgf/cm (Room Temp., °C) (Vacuum) Figure 46 to start “Flash Program”. The corresponding sterilization time will be: C.
  • Page 35 On completion, the buzzer will sound at the same time and the temperature panel will flash. The program has finished when the buzzer STOPS and the COMPLETE indicator light is illuminated on the Process Status Indicator. WARNING: If the COMPLETE indicator light was not lit, the cycle has failed and should be run again.

  • Page 36: Prion Program

    6.7 PRION Program Before start Sterilization program please refer to “6.2 Prepare Sterilization” section. How to set the PRION program 134°C 120°C 103°C 0 bar (kgf/cm (Room Temp., °C) (Vacuum) Figure 48 to start “PRION Program”. The corresponding sterilization time will be: C.

  • Page 37: Test Program

    Open the door and take out the sterilized items. 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.
  • Page 38 selected program. The current progress of the sterilization cycle is indicated by the illuminated LED on the Process Status Indicator. (Figure 51) NOTE: The DRY step won’t be performed. Figure 51 On completion, the buzzer will sound same time the display will flash. The program has finished when the buzzer STOPS and the COMPLETE indicator light is illuminated on the Process Status Indicator.

  • Page 39: Pump Test Program

    6.9 PUMP TEST Program Before start Sterilization program please refer to “6.2 Prepare Sterilization” section. How to set the PUMP TEST program 0 bar (kgf/cm (Vacuum) Figure 52 to start “PUMP TEST Program”. The corresponding sterilization time will be: C. Press Sterilization Time Sterilization Temperature Dry Time...
  • Page 40 WARNING: Check the Pressure Gauge is reading ZERO before opening the door. (Optional) MA-R series 0 bar (kgf/cm Vacuum Figure 54 to start “PUMP TEST Program”. The corresponding sterilization time will be: Press Sterilization Time Sterilization Temperature Dry Time Vacuum Time 10 min Wait 15 min...

  • Page 41: Vacuum Release

    On completion, the buzzer will sound (long beep). The program has finished when the buzzer STOPS and the COMPLETE indicator light is illuminated on the Process Status Indicator. After the program ends, the leak detection is made. WARNING: If the COMPLETE indicator light was not lit, the cycle has failed and should be run again.

  • Page 42: Placement For Items To Be Sterilized

    WARNING: Disposal of the items which is sterilized by unfinished cycle should be in accordance with the local laws. Do not handle them as general waste. NOTE: If the Emergency Button had been pressed without opening the door, you may require repeating this emergency to release the pressure.
  • Page 43 Figure 58 WARNING: We suggest using Spring Holder for items with sterilizing pouches to assure sterilization result. Follow Figure 59 or Figure 60 to place each pouch separately. Spring holder is available as an optional accessory. Figure 59 Figure 60...

  • Page 44: Sterilization For Wrap

    WARNING: If implements are packed with sterilizing pouches and placed inside a sterilization box, make sure to display items as Figure 61. Figure 61 6.13.2 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 62.

  • Page 45: Glassware

    Figure 63 WARNING: Please follow above Figure 63 and place wrap vertically inside the sterilization box. 6.13.4 Glassware Use only heat-proof glass. Verify that the beaker is only filled 2/3 full and the lid is on loosely to allow for expansion. Items should not be allowed to touch the walls of the Chamber as the hot metal can damage the item.

  • Page 46: Recorder

    7. Recorder 7.1 Intended use This paperless Recorder records the sterilization temperature, theoretical steam pressure and real time information during each cycle as an optional method of printer. It records the specified information onto an USB flash drive, in the Excel csv (Comma Separated Values) format which ®...

  • Page 47: Description Of Detail Content

    7.2.1 Description of Detail Content Printer output Description Model number MODEL:SA-260MA-R Software version installed in this autoclave Version:V0.99 Series number SN：161005204-001 Program selected Program： 134 Unwrapped Sterilization temperature Ster. Temp：134 ºC Sterilization duration Ster. Time： 4 m Dry duration Dry Time： 15 m Date and Time of sterilization Date：2016/06/13 Time：10:45:57 AM...

  • Page 48: Description Of Summary Contents

    058:31 111.3 0.07 059:32 111.2 0.08 The maximum and minimum temperature Ster. Temp ： 134.7 ~ 136.2 ºC detected during sterilization period The maximum and minimum pressure Ster. Pres ： 2.12 ~ 2.22 bar detected during sterilization period Sterilization period Ster.
  • Page 49 040:20 136.6 2.14 every 1 minutes after “S00”; and also the last 043:22 98.2 0.08 058:31 111.3 0.07 sterilization time 059:32 111.2 0.08 exhaust of water and steam dry time-started dry time-finished end of recording The maximum and minimum temperature Ster.

  • Page 50: Storage Medium

    7.3 Storage medium Use only recommended storage medium by the manufacturer such as USB (2.0) flash drive. You should format your storage medium prior insert into the Recorder for the first time. You can operate on the files in this card in PC via a card reader. Data will be stored under the root directory only.

  • Page 51: Recorder Panel

    7.4 Recorder panel ▲Increase button 1) to move cursor backward LCD: 2) to advance digits 1）Display date and time 2）Display chamber temperature 3）Recording status SET button： ▼ Decrease button 1）to set the parameter 1) to move cursor 2）to confirm adjustment forward 2) to decrease digits USB port...

  • Page 52: General

    7.5.1 General There are 3 types of operation modes for the recorder, they are stand-by mode, recording mode, and adjusting mode. 7.5.1.1 Stand-by mode The date and time will be displayed after turn on the main power, and low battery symbol will flash for charging and/or low battery as shown in Figure 67.

  • Page 53: Adjusting Mode

    Please Wait ! Data transfer 2016- Apr-24 Completed 13:30:30 Data transfer… Figure 69 NOTE 1: If none of the USB flash drive being detected before completing a sterilization cycle, 2 warming messages “E105: No USB memory” followed by a buzzer alarm are presented.

  • Page 54: Set Up

    7.5.2 Set up 7.5.2.1 Set up date and time Press “SET” button for adjusting the parameters of the recorder while in the stand-by mode. Press increase (▲) or decrease (▼) until “1. Date / Time” displayed as shown in Figure 71. 1.

  • Page 55: Remove Usb

    The sequence is in the order of Temperature - Pressure each time you press the “Set” button. After entering the unit, press “Set” button returns to the Set manual, and then to choose “8. EXIT” press “Set” button again returns to the stand-by mode as shown in Figure 72. 7.5.2.3 Remove USB CAUTION: The data may be damaged if not follow this operation to detach the USB flash drive properly.

  • Page 56: Download

    7.5.2.4 Download WARNING: The recorder can operate without a USB flash drive, but the data stored in the recorder will be overwritten by the next sterilization data if the recorder memory is full. Manufacturers strongly recommend that you use a USB flash drive as a storage medium and always back up the USB flash drive to a secure area.

  • Page 57: Cycle

    5. Printer Figure 80 Press the Setup button to select the printer contents, then press the (▲) and/or (▼) buttons to select as shown in Figure 81. Printer: ON Figure 81 Press “SET” button returns to the Back to previous page. 7.5.2.6 SN: Press the "SET"...

  • Page 58: Message And Troubleshooting (For Recorder)

    7.6 Message and troubleshooting (for recorder) Symptom Solution No display - Turn on the main switch. - Plug the power cable. - Check if bad connection. - Contact local distributor for service E101: Temp. Sensor fail - Contact local distributor for service E103: Pressure sensor - Contact local distributor for service fail...

  • Page 59: Test Instructions

    8. Test Instructions 8.1 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 60: Air Removal (Bowie-Dick Type Test Pack)

    8.2 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 61 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 62: Helix Test

    8.3 Helix test The Helix test represents a hollow A-type load, i.e. the load with the most critical characteristics. Carry out the test as follows (Example of TST LOADCHEK STEAM): WARNING: TST LOADCHEK STEAM is trademark of ALBERT BROWNE LTD., 1.
  • Page 63 WARNING: The HELIX Test kit will be very hot! 6. Open the capsule and remove the test strip. 7. Please ask your dealer of HELIX test. 8. The result is as follows: Incorrect result: Figure 88 Incorrect result: Figure 89 correct result: Figure 90...

  • Page 64: Maintenance Instructions

    9. 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 65 Clean the filter Use a wrench to unscrew the filter nut counterclockwise as Figure 91 and Figure 92. CAUTION: Place a towel underneath the filter tap to avoid leakage. Counterclockwise Filter Nut Towel Figure 91 Take out the filter following the direction of the arrow.

  • Page 66: Monthly

    9.3 Monthly Use the non-corrosive cleaner and stiff bristled brush or sponge to clean the water level sensor at the rear of the chamber as Figure 94. 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 67: Annually

    9.4 Annually 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 during sterilization process. (Use biological indicators to test the validity of sterilization) Check if there’s any leakage of the piping.

  • Page 68: Troubleshooting

    10. Troubleshooting 10.1 Symptoms Problem Possible Cause Solution The main cable is unplugged or the Plug in the sterilizer and turn on the socket switch. socket switch is off. Power Forget to turn on the indicator isn’t Press the Power switch to ON ”I” position. switch.

  • Page 69: List Of Error Codes (For Autoclave)

    10.2 List of Error Codes (for autoclave) ERROR Description CODE K-type sensor in chamber is out of connection (Emergency light illuminates) The door is not closed completely (Door light illuminates) Sterilization temperature over than 137°C (Emergency light illuminates) The water tank is in LOW WATER condition (LOW-WATER light illuminates) Water in the chamber is not enough in first 5 min.

  • Page 70: Specifications

    11. Specifications Model SA-230MA-R Chamber Capacity (L) Maximum Instrument Length (mm) Maximum Load (unpouched) (g) 5,000 Maximum Load (pouched) (g) 1,000 External Dimensions (mm) 594 (D) x 522 (W) x 410 (H) Chamber Size (mm) 230 Diameter x 410 Depth Gross Weight (kg) Voltage/Frequency/Wattage 220V-240V AC, 50/60Hz, 1926W...
  • Page 71 Model SA-230MA-R Pressure Display Analog pressure gauge Function Display Recorder Memory Recorder, up to 32 G USB (2.0) flash drive Wrapped (121°C 78 min/ 134°C 65 min), Unwrapped (121°C 48 min/ 134°C 41 min), PRION (70 min), B.D. Test (25 min), Pump Test (16 min), Program Liquid (137-182 min), Flash...

  • Page 72: Warranty

    12. Warranty WARRANTY "STURDY" product has one (1) year warranty from the date of purchase that covers any defects in materials and quality under regular use. This warranty does not apply to any product damaged by accident‚ misuse, abuse‚ neglect‚ improper line voltage‚...
  • Page 73 Sturdy Autoclave Sterilizer Name SA-230MA-R Model Manufacturer Sturdy Industrial Co. Ltd. 168, Sec. 1, Zhongxing Rd., Wugu District, Address New Taipei City, 24872, Taiwan EC Representative APEX MEDICAL S.L. Elcano 9, 6 ª planta 48008 Bilbao. Vizcaya SPAIN 422-02079-01...

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