CPAC SteriDENT 300 Operating Instructions Manual

Dry heat sterilizer

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Dry Heat Sterilizer models 200 and 300
Operating Instructions
MODEL
200
MODEL
300
2364 Leicester Road, P.O. Box 175, Leicester, NY 14481
Phone (585) 382-3223 ● Fax (585) 382-9481 ●
www.cpac.com
Rev 4, 18 October, 2019
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  • Page 1 Dry Heat Sterilizer models 200 and 300 Operating Instructions MODEL MODEL 2364 Leicester Road, P.O. Box 175, Leicester, NY 14481 Phone (585) 382-3223 ● Fax (585) 382-9481 ● www.cpac.com Rev 4, 18 October, 2019...
  • Page 2: Table Of Contents

    Table of Contents Safety Precautions ……………………..…….…………………………….. Operating Instructions ……………………………….…………………………. Sterilizer Setup ………………………………………………………….. Instructions for Operation ………………………………………………. Mechanical Timer ………………………………………………………….. Cycle Start …………………………………….……………………………..… Maximum Loading ………………………………………………………….. Material Integrity ……………………………………………………..Cautions ………………………………………………………….. Instruments validated for use …………………………….…….. Safety notes on Temperature …………………………………... Thermometer &...
  • Page 3: Safety Precautions

    To avoid electrical shock hazard, do not disassemble this appliance unless you are an authorized service technician. Contact a CPAC authorized service technician when service or repair work is required. Incorrect reassembly can cause an electric shock hazard. Unauthorized repair or replacement of parts by non-certified personnel will void of all warranty guarantees.
  • Page 4: Operating Instructions

    OPERATING INSTRUCTIONS STERILIZER SET UP (First time only) Before using the sterilizer for the FIRST time, the thermostat setting must be checked to ensure the sterilizer will operate at the proper temperature. For 320°F (160°C), verify the number “7” on the thermostat dial is lined up with the black marking dot located on the right side of the sterilizer.
  • Page 5: Cycle Start

    CYCLE START - Before beginning a sterilization cycle, be sure instruments are clean and free of debris (for information about which materials can be safely sterilized refer to instruments validated for use in the sterilizer above). Prepare all instruments for sterilization by rinsing or using an ultrasonic cleaner, as recommended by the Centers for Disease Control (CDC).
  • Page 6: Material Integrity

    These complex devices should only be sterilized according to the device manufacturer’s instructions. A list of instruments compatible for dry heat sterilization can be found on our web site at www.cpac.com.
  • Page 7: Safety Notes On Temperature

    The Steri-DENT sterilizer comes equipped with two or three instrument trays and a tool for changing trays. Biological indicator test strips, spore testing kits, and Steri-Dent brand nylon pouches are available from your distributor or CPAC. Depending on the size of your practice, you may wish to purchase additional trays.
  • Page 8: Spore Test Strips

    An authorized service representative or CPAC should be contacted if any of these parts need to be replaced. Replace the inner door gasket once a year, or sooner if it becomes loose or worn. Order gasket #201108 for Model 200 or #301108 for Model 300.
  • Page 9 Figure 2: Test Load Configuration for Model 2100 Figure 3: Test Load Configuration for Model 3100...
  • Page 10: Environmental Conditions

    ENVIRONMENTAL CONDITIONS The Steri-Dent sterilizer is designed for indoor use with the following conditions: Temperature Range of 5°C to 40°C (41°F to 104°F) • • Maximum Relative Humidity of 80% up to 31°C (88°F). Decreasing linearly to 50% at 40°C (104°F). Pollution Degree 2 applies in accordance with IE 664.
  • Page 11: Failure Symptoms And Troubleshooting

    The following symptoms or failures listed in Bold are followed by steps to help trouble shoot the cause of the symptom or failure. If the information in this technical manual does not help in correcting or repairing the problem, please contact CPAC Technical Service at 585-382-3223. Burning/Melting bags/pouches – Verify the following: 1) Temperature reads 320-330°F.
  • Page 12 Timer not timing down – Verify the following: 1) Check that timer dial turns properly. Must turn past 10 minutes for timer to work. 2) Empty sterilizer and turn timer to 120 minute setting. If timer does not reach 0 (zero) in 2 hours, replace timer (201042S).
  • Page 13: Troubleshooting Quick Reference Guide

    STERI-DENT Model 200/300 Troubleshooting Quick Reference Diagnosis and Repair Chart STERI-DENT MODEL 200/300 FAILURE/ERROR CODE VERIFY Remedy Failing spore tests 1) Thermometer reads 320-330°F Adjust thermostat to obtain before cycle is started. correct thermometer range. Replace thermostat. Refer to Steri-Dent Thermostat Replacement Instructions for assistance.
  • Page 14 3) Thermometer too cold Check thermometer is threaded under chamber insulation. 4) Knob adjusted too high/low Set knob to 7 and stabilize temp. If unit won’t hold 320- 330°F, replace thermostat. Refer to Thermostat replacement instructions Unit not heating or No 1) Unit plugged in.
  • Page 15: Product Specifications

    Three years (parts and labor) Models: 200, 300 Approvals: ETL FDA 510(k) K771070 IEC Safety Standard 61010-2-040 UL 61010-1, CAN/CSA C22.2 No. 61010-1 For additional technical advice, service instructions or parts, contact CPAC Equipment, Inc. Technical Services: (800) 828-6011 or (585) 382-3223...
  • Page 16: Spare Parts List

    STERI-DENT STERILIZER SPARE PARTS LIST Many of the items listed below require installation by an appropriately trained technician. Contact CPAC by telephone at (585) 382-3223 for assistance. Part Number Description MODEL 200 Part Number Thermostat, SD 200 201032 Extra Tray for Model 200 – 10 x 6 ¼...
  • Page 17: Biological Testing Protocols

    Hospitals, and the Centers for Disease Control recommend biological indicator tests to verify the sterilizer’s performance. CPAC Equipment, Inc. recommends that a biological indicator and the recommended test load of 2.6 lbs for model 200 and 4.2 lbs for model 300 be used on a weekly basis or every 25 cycles, whichever comes first, to test the effectiveness of the sterilizer.
  • Page 18 demonstrate that the thermal process is providing all conditions necessary for sterilization to occur, biological indicator strips containing 6 Logs of Bacillus atrophaeus spores are used for periodic process validation. B. atrophaeus spores are rated most thermal-resistant in the hierarchy of resistance over all other RNA/DNA-containing microbial categories (i.e., viruses, vegetative bacteria, fungi, parasites, and mycobacterium).
  • Page 19 Testing for the Steri-DENT Sterilizer” (page 15-16). Procedure: 1. Prepare the sterilizer per the warmup instructions. 2. Load the instruments into Steri-DENT self-sealing nylon pouches or other CPAC pouches recommended for dry heat. If not pouching, layer instruments in the instrument tray with no instrument overlap.
  • Page 20 8. Record the parametric operating conditions (date, times, and temperatures) of the test cycle in five (5) minute intervals throughout the test and place into the Biological Test Data Manual. 9. When the cycle ends, immediately and carefully remove the spore test strip for culturing.
  • Page 21 These protocols will assist the customer and CPAC Equipment technicians in determining the cause of the spore test failure, and determining whether the sterilizer should be taken out of service and returned to CPAC Equipment for further evaluation.
  • Page 22 Submit spore strip to the contracted laboratory for analysis or perform on-site analysis. 5. If the second spore test results in a failure, call CPAC Equipment (800-828-6011) and ask for a service technician to discuss the problem and to determine a cause for failure.
  • Page 23: Biological Indicator Testing Checklist

    Checklist for Weekly/Monthly Biological Indicator Testing for Steri-DENT Sterilizer (Upon Completion Place This Form in Biological Test Data Manual) Date_________ Cycle Start Time ____________ Cycle End Time ____________ Operator___________________________________________ Sterilizer Equipment Model/Serial Number ______________________________________ Pre-Check Prior to Initiation of Sterilization Cycle ☐...
  • Page 24: Statement Of Warranty

    All units must have a Return Material Authorization code (RMA) visible on the returned item. RMA’s can be obtained by calling CPAC at (585) 382-3223. EVERY EFFORT HAS BEEN MADE TO ENSURE THE COMPLETE ACCURACY OF THE CONTENTS OF THIS MANUAL.

This manual is also suitable for:

Sterident 200

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