CPAC RapidCyde RapidHeat RH-Pro11 Operation Manual

CPAC RapidCyde RapidHeat RH-Pro11 Operation Manual

High-velocity hot air (“hvha”) sterilizers
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RH-Pro 11 OPERATION MANUAL
High-Velocity Hot Air™ ("HVHA") Sterilizers
Model: RapidHeat™ RH-Pro11
2364 Leicester Road, PO Box 175, Leicester, NY 14481  800-828-6011  585-382-3223
CPAC.com
Printed in U.S.A. Copyright 2018

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  • Page 1 RH-Pro 11 OPERATION MANUAL High-Velocity Hot Air™ (“HVHA”) Sterilizers Model: RapidHeat™ RH-Pro11 2364 Leicester Road, PO Box 175, Leicester, NY 14481  800-828-6011  585-382-3223 CPAC.com Printed in U.S.A. Copyright 2018...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS Important Information…………………………………………………………………………….…………...4 Safety Information………………………………………………………………………………………...……..5 Accessories and Consumables………………………………………………………………………………8 Components and Control Functions………………………………………………………………………9 Installation………………………………………………………………………………………….……………..10 Operation…………………………………………………………………………………………………………..12 Sterilization Validation Guidelines………………………………………………………………………25 Maintenance ………………………..……………………………………………………………………………29 Cycle Documentation………………………………………………………………………………..………..29 Troubleshooting…………………………………………………………………………………………….…..32 RH-Pro11 Specifications……………………………………………………………………………………..33 RH-Pro11 Warranty…………………………………………………………………………………….……..34 APPENDIX I Sterilization Verification – Microbiological Inactivation Efficacy……..36 Checklist for Weekly/Monthly Biological Indicator Testing…...….……38 APPENDIX II Cabinet Installation of the RH-PRO11…………………………………………..39...
  • Page 3 CONGRATULATIONS on selecting an RH-Pro11™ High-Velocity Hot Air Sterilizer. The RH-Pro11™ Sterilizer employs High-Velocity Hot Air (HVHA) to sterilize medical and dental instruments. Radically different than steam sterilization, HVHA technology uses fluidized hot, dry air that transfers heat energy to instruments by a combination of convection and conductive processes.
  • Page 4: Important Information

    Model Number*: ______________________________ Serial Number*: _______________________________ *Located on the right back side of the sterilizer Limited Warranty CPAC Equipment, Inc. provides a limited three-year warranty for the RH- Pro11 on parts and labor as described in Section 12 of this manual.
  • Page 5: Safety Information

    SAFETY INFORMATION The RapidHeat RH-Pro11 is designed for easy operation and maintenance. For safe and reliable operation, please read and understand the installation and operating instructions contained in this User Guide. All personnel charged with the operation of the RH-Pro11 should be aware of this User Guide and follow its contents.
  • Page 6 2.2.1 Cautions  During operation, the exterior surface of the sterilizer remains comfortable to the touch; however, the tray and the sterilized instruments will be hot. Use only the provided heat-resistant gloves for removing the instrument tray and sterilized instruments. Use caution when handling hot instruments.
  • Page 7  The door cannot be opened during a sterilization cycle without the operator pressing “Cancel” on the key pad. In the event that the temperature drops below 372°F, the cycle timer will reset and the sterilization cycle will restart after reaching the 375°F operating temperature.
  • Page 8: Accessories And Consumables

    USB Cable A to B Type, 6’ Length 400676 Auto Cutter 3” 1-Ply Printer Paper/case (50 rolls) 400677 Heat-Resistant Gloves 400672 Consumables (Contact CPAC Equipment for More Information) DESCRIPTION RAPIDHEAT PEEL POUCHES RAPIDHEAT STERILIZATION WRAP NYLON (TEAR) POUCHES CHEMICAL INDICATORS BIOLOGICAL SPORE TEST INDICATORS...
  • Page 9: Components And Control Functions

    4. COMPONENTS AND CONTROL FUNCTIONS 4.1 Components FRONT ELEVATION Touch Pad Display Door On/Standby Button Door Handle and Lock USB Port REAR ELEVATION Blower Motor Cooling Air Exhaust Model & S/N # Plate Blower Motor Cooling Air Supply Circuit Breaker Power Cord...
  • Page 10: Installation

    Open Door Instrument Sterilization Door Door Hinge Tray Chamber Gasket INSTALLATION Unpacking the Sterilizer * DO NOT CUT THE BOX OPEN OR AWAY FROM THE STERILIZER! * The RH-Pro11 weighs approximately 95 pounds and with its dimensions, makes the unit difficult to be lifted by one person. To remove from the shipping carton, it is best to remove the top packing cushion and use the (2) two nylon lifting slings (see picture below) encompassing the sterilizer to make lifting the unit out easier.
  • Page 11 Sterilizer Nylon Lifting Straps Cushioning Location The RH-Pro11 is designed for operation indoors in a protected,  relatively dust-free ambient temperature environment at a relative humidity of < 80% up to 88 F (31  Surface Support – Level and of sufficient construction for weight of loaded sterilizer (approximately 100 pounds) and ancillary equipment.
  • Page 12: Operation

    Electrical Requirements ELECTRICAL WARNING! For 115 VAC Models: Use 110-120 VAC, 60Hz alternating current only. For 230 VAC Models: Use 220-240 VAC, 50/60Hz alternating current only. Failure to do so may result in electrical shock or sterilizer damage. 115 VAC Unit: 110-120 VAC, 12 amp, 60Hz 1400 W warm-up 300 W operating...
  • Page 13 WARNING – HOT SURFACES! The sterilizer’s interior, doorway, trays, and the sterilized instruments will be hot. Use heat-protective gloves when touching hot surfaces or objects. General Guidelines for Instrument Loading 6.2.1 Instrument and Materials Compatibility For a high-velocity hot air (HVHA ) sterilizer operating at 375 F, most ™...
  • Page 14 C) and must be cleared by the FDA for use in a dry heat environment. It is recommended that the pouches and wrap offered by CPAC Equipment, Inc. be used for assurance of quality.  Use instrument trays provided with the RH-Pro11 that have been designed to provide required hot airflow from all directions to unwrapped and wrapped/pouched instruments.
  • Page 15 Operation of the RH-Pro11 6.3.1 High-Velocity Hot Air Sterilization Principles  The RapidHeat™ Pro11 sterilizer utilizes dry, rapidly flowing air to sterilize instruments. This process is both a heat conduction and heat convection process and requires that all instruments be directly subjected to the hot, high-velocity moving air.
  • Page 16 instrument weights per tray or per instrument, or load configuration may jeopardize the efficiency of treatment. 6.3.3 Sterilization Cycles - Capacity Restrictions and Limitations  UNWRAPPED INSTRUMENT CYCLE Unwrapped Instruments Sterilization Instructions  To sterilize unwrapped instruments, place them into the instrument tray under the loading and capacity limitations and restrictions noted below for the UNWRAPPED Cycle.
  • Page 17 Unwrapped Instruments  Instrument Weight Limitation Per Tray: 800 g or 1.75 lbs.; Limit 4 Trays  Single Instrument Weight Should Not Exceed 220 g or 0.5 lbs.  Instruments Cannot Overlap or Be Layered, Piled, or Stacked  Instruments Must Lay Directly on Tray Bottom ...
  • Page 18 Unwrapped Handpieces  Handpiece Weight Limitation Per Tray: 800 g or 1.75 lbs.; Limit 4 Trays  Single Instrument Weight Should Not Exceed 220 g or 0.5 lbs.  Handpieces Cannot Overlap or Be Layered, Piled, or Stacked  Handpieces Must Lay Directly on Tray Bottom ...
  • Page 19 Pouched Handpieces Must Lay Directly on Tray Bottom Pouched Instruments Carriers Laying Horizontal in Tray  CPAC 2.5” x 8” Instrument Carrier (With Instruments) Weight Limitation Per Tray: 800 g or 1.75 lbs.; Limit 4 Instrument Carriers per Tray; Limit 4 Trays: Limit 200 g per Pouch ...
  • Page 20 6.3.4.2 “Start-of-Day” Sterilizer Preheating Procedures At the start of the day the RH-Pro11 will require time to pre-heat the internal metal and insular components that serve as a heat sink to the heated air of the system. “Start-of-Day” sterilizer heating process includes the heating of the chamber to 375°F and holding it through a sterilization cycle (see below).
  • Page 21 Press “SELECT” Pressing on the selected option or “CANCEL” will return display back to the “READY” screen, which will indicate the sterilization option selected. Instrument trays may now be loaded into the sterilizer chamber, ensuring that the trays are pushed all the way to the backstop on the tray rails.
  • Page 22 It should be noted that the temperature reading on the display screen is that of the sterilization chamber at the air exhaust port. This temperature reading is the most indicative of the instrument heating process. As air is heated to 375°F by the heaters located in the upper and lower plenums, the air will lose temperature to the instruments as they heat up.
  • Page 23 “READY” screen with changes 6.3.5.3 Upload Software Via USB Port To upload updated software provided CPAC Equipment, Inc. (CEI) via USB flash drive press “MENU” from “READY” screen to display “SELECT ITEM” screen. Press “SOFTWARE UPDATE.” Follow loading instructions by CEI-provided with the software.
  • Page 24 Six formats or operational parameters are presented of which the operator may make changes. Note that none of these operator configurations will affect treatment times and temperatures required of the sterilization process. Press the desired category and follow instructions on the screen for attribute selection. Once the option is selected, the screen reverts to the “CONFIGURATION”...
  • Page 25: Sterilization Validation Guidelines

    State or local requirements (public health departments) for biological testing may also apply. CPAC Equipment, Inc. recommends that a test be performed every 25 cycles, or at least once a week, to test the effectiveness of the RH-Pro11. Recommended Chemical and Biological Indicators Biological indicators (i.e.
  • Page 26 For the 12-minute Cycle, load the instruments into SteriSURE self-sealing nylon pouches or other CPAC pouches recommended for dry heat and add a chemical indicator and biological indicator strip to the selected test pouch. Take extreme care not to...
  • Page 27 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. It should be noted that there are numerous factors that can lead to a failed spore test other than sterilizer failure.
  • Page 28 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. Provide the technician with information necessary for determination of failure cause and steps that may be required to remedy the problem.
  • Page 29: Maintenance

    Messages” for a list of potential error messages or see Section 10 “Troubleshooting” for performance symptoms that would indicate the possible need for service. If such an occurrence, call CPAC Equipment at (585) 382-3223 to have the equipment evaluated and shipped back to the factory for repair.
  • Page 30 up to 100,000 sterilization cycles, it is recommended that data be downloaded via the USB flash drive daily or weekly and stored on a personal computer or office share drive for easy retrieval, or for printing along with data from the biological and chemical indicator tests. Time-Date Setting The date and time should be set in the sterilizer so that information in the data log is correct as to time.
  • Page 31 Time and Date”, to adjust the time settings. The calendar does not handle Leap Year automatically. The clock does not perform Daylight/Standard time changes automatically. STERILIZATION CYCLE LOG FILE The log file name is mm-dd-yy.TXT, for example, 5.01.19.TXT for a log that is written on May 1, 2019.
  • Page 32: Troubleshooting

    TROUBLESHOOTING PROBLEM POSSIBLE CAUSE WARN, IND, SOLUTIONS or ERR No Power -Unit unplugged -Check outlet  -Turn on breaker -Breaker Off -Check circuit breaker  -No power at outlet -Contact Authorized Service  -Bad fuse on PCB Technician No Display or -Bad LCD -Contact Authorized Service Grey screen...
  • Page 33: Rh-Pro11 Specifications

    -Torn or Open IND/WARN -Check Biological Indicator Biological Indicator Envelopes for Proper Seals, Envelope Cuts, or Tears -See Sec 7.3 RH-PRO11 SPECIFICATIONS SPECIFICATIONS Electrical Rating RH-Pro11 115 VAC 120 VAC +/- 10%, 60Hz, 12 Amps 1400 Watts warm-up, 300 Watts operating Transient Over-Voltage Category II Applies RH-Pro11 230 VAC 230 VAC +/- 10%, 50/60Hz, 6 Amps...
  • Page 34: Rh-Pro11 Warranty

    LIMITED WARRANTY CPAC Equipment, Inc. (CEI) certifies that all equipment manufactured by CEI at its Leicester, New York factory has been produced to exacting standards and has been tested and inspected for proper workmanship and performance. CEI further warrants that any equipment or components found to be faulty or defective will be repaired or replaced by CEI for a period of 36 months from date of delivery of CEI equipment to Customer by CEI or CEI’s authorized...
  • Page 35 Customer acknowledges that any oral statements about the CEI Products equipment and/or components in any contract made by CEI’s representatives, if any such statements are made, do not constitute warranties, shall not be relied upon by Customer and are not a part of the contract for sale for CEI equipment.
  • Page 36: Appendix I Sterilization Verification - Microbiological Inactivation Efficacy

    APPENDIX I STERILIZATION VERIFICATION – MICROBIOLOGICAL INACTIVATION EFFICACY Biological indicators are used in healthcare to validate protocols and operational parameters of a sterilization process. Sterilizers are operated under standard operational protocols required of the manufacturer to meet FDA and ANSI/AAMI standards and criteria.
  • Page 37 In-house culturing is an option from which cultured spore strips can be monitored throughout the seven-day incubation period for growth. Although a full seven days is required for culturing, spore strip failures are usually seen within the first 24-48 hours of culturing as indicated by color change and media turbidity. Although in- house biological monitoring is an option for a more timely indication of a spore strip failure, this culturing process requires the stringent use of proper sterile technique when transferring the spore strip to the culture media to avoid the introduction of an...
  • Page 38: Checklist For Weekly/Monthly Biological Indicator Testing

    Checklist for Weekly/Monthly Biological Indicator Testing for RH-PRO11 Sterilizer (Upon Completion Place This Form in Biological Test Data Manual) Date___________________ Cycle Start Time ____________ Cycle End Time ____________ Operator___________________________________________ Sterilizer Equipment ID/Serial Number ______________________________________ Pre-Check Prior to Initiation of Sterilization Cycle ☐...
  • Page 39: Appendix Ii Cabinet Installation Of The Rh-Pro11

    APPENDIX II INSTALLATION PROCEDURES AND CONSIDERATIONS FOR CABINET INSTALLS It is RECOMMENDED that this equipment be countertop installed to obtain the maximum amount of ventilation airflow. A ventilation fan is installed with a user- cleanable filter, described elsewhere in this manual. The Pro11 has an internal ventilation fan at lower right (viewed from the front) of its rear panel.
  • Page 40 Power cord must be free to extend and retract when pullout moved o See Fig. 2 Fig. 2A, Pullout enclosure Fig. 2B, Pullout fully Extended 2364 Leicester Road, PO Box 175, Leicester, NY 14481  800-828-6011  585-382-3223 CPAC.com Printed in U.S.A. Copyright...

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