CPAC RapidHeat RH-N95 Operation Manual Download Page 33

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traditional    dry    heat    technologies    in    which    air    remains    static    (air    movement    only    by    gravity   
convection)    or    in    which    air    is    minimally    re-­‐circulated    by    mechanical    convection    to    enhance    heat   
distribution.   Derived   from   NASA   dry   heat   technology   HVHA   technology   employs   directed,   uniform   
high-­‐velocity    hot    air    across    the    surface    of    a    medical    device    to    enhance    heat    transfer.    As    a    heat   
conduction   process,   this   high   velocity,   thermodynamic   mechanism   decontaminates   both   the   surface   
and    the    interior    of    a    device    and    its    components,    including    residues    that    may    still    be    retained.    The   
result    is    a    marked    reduction    in    time    required    for    mask    decontamination    by    traditional    dry    heat   
methods.   

   

The   RH-­‐Pro11   technology   has   been   repurposed   into   the   RH-­‐N95   Mask   Decontamination   System   that   
is    solely    dedicated    to    N95    mask/respirator    decontamination.    Using    a    dual    airflow    pathway,    air   
heated   to   (167°F   +0.5°F;   75°C)   and   is   mixed   to   homogeneity   before   entering   the   processing   chamber   
at    a    velocity    that    delivers    about    200    air    exchanges    per    minute.    The    closed    air-­‐handling    system   
provides    the    ability    to    control    and    maintain    the    pre-­‐set    temperature    throughout    the    entire    34-­‐
minute   decontamination   process.   As   a   dry   heat   process,   only   temperature   and   time   are   the   critical   
cycle   parameters   in   this   process.   The   use   of   a   proportional-­‐integral-­‐derivative   controller   optimizes   
sterilization    chamber    warm-­‐up,    more    precisely    maintains    plenum    temperatures,    minimizes   
temperature    over-­‐    and    under-­‐    shoot,    and    speeds    heater    element    response    to    provide    the   
temperature   control   necessary   for   this   process.   The   on-­‐board   computer   monitors   the   entire   process   
and    if    significant    deviations    occur    from    prescribed    parameters,    error    messages    are    displayed,   
delineating   the   problem.   If   these   errors   result   in   significant   deviance   of   required   time-­‐temperature   
parameters   that   are   required   for   desired   viral   or   bacterial   inactivation   levels,   the   unit   will   terminate   
the   cycle,   notify   the   operator   of   the   event,   and   document   the   incomplete   cycle   in   the   stored   data   log.   

The    decontamination    cycle    for    the    RH-­‐N95    is    set    for    a    30-­‐minute    exposure    at    167°F    (75°C),    a   
relatively   low   temperature   and   one   that   cannot   kill   bacterial   spores   nor   has   an   approved   chemical   
indicator.   For   monitoring   of   the   mask’s   time-­‐temperature   conditions   a   better   alternative   is   offered   
by   placing   a   thermal   sensor   logger   next   to   or   under   a   mask   during   the   decontamination   process.   The   
time-­‐temperature    data    is    recorded    during    the    process    and    upon    completion    of    the    cycle    is   
downloaded    onto    the    RH-­‐N95’s    computer    for    graphical    screen    display    and    internal    storage.    The   
operator    is    instructed    to    acknowledge    these    results    before    the    next    cycle    can    be    initiated.    The   
logger’s    data    is    concurrently    stored    with    the    time-­‐temperature    data    generated    from    the    RH-­‐N95’s   
chamber    temperature    sensor    and    available    for    download    to    a    flash    drive    for    off-­‐site    storage    and   
hardcopy   documentation,   if   desired.   See   Figures   1   and   2   below.   

   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   

Figure   1   

Summary of Contents for RapidHeat RH-N95

Page 1: ...RH N95 OPERATION MANUAL High Velocity Hot Air HVHA Model RapidHeat RH N95 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: ...ol Functions 10 Installation 11 Operation 13 Independent Temperature Logger 23 Maintenance 25 Cycle Documentation 25 Troubleshooting 28 RH Pro11 N95 Specifications 29 RH Pro11 N95 Warranty 31 APPENDIX...

Page 3: ...avirus and Mycobacterium indicates that a 6Log10 reduction in both microbial species can be achieved under the time temperature parameters established for the N95 Mask cycle Bacterial spores cannot be...

Page 4: ...g carton packing materials and straps in the event this product may need to be returned to the manufacturer for repairs Failure to retain the carton and materials will result in additional charges for...

Page 5: ...IS USER MANUAL FOR FUTURE REFERENCE 1 1 Contact Information Dealer Authorized Service Representative 1 2 User Reference Information Date of Purchase Model Number Serial Number Located on the right bac...

Page 6: ...sitive and that can withstand decontamination at temperatures of 167 F 75 C bagged or un bagged Never use the RH N95 for processing liquids chemicals or radioactive materials 2 1 Safety Symbols WARNIN...

Page 7: ...ain uniform temperature throughout the processing chamber The temperature control maintains a uniform exhaust temperature of 174 F 79 C as indicated on the keypad display with a variability of 1 F The...

Page 8: ...a properly grounded fuse breaker protected outlet 110V 60 cycles or a 220 240V 50 cycles A separate circuit is recommended for this unit To protect against electrical shock hazard do not immerse in wa...

Page 9: ...ne Pair User Manual CIR Thermal Sensor Logger DESCRIPTION PART NUMBER RH N95 Mask Tray PR0057 Epson TM U220B Printer with Auto Cutter 400674 Epson TM U220A Printer with Journal and Auto Cutter 400675...

Page 10: ...UNCTIONS 4 1 Components FRONT ELEVATION REAR ELEVATION Blower Motor Cooling Air Exhaust Model S N Plate Blower Motor Cooling Air Supply Circuit Breaker Power Cord Touch Pad Display Door On Standby But...

Page 11: ...d 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 unit to make lifting the unit...

Page 12: ...e to Front Sterilizer 1 25mm 5 3 4Sides of Unit to Side Wall 3 75mm See Note below 5 3 5Distance Above the Unit 3 75mm NOTE The main power on off circuit breaker is located at the right rear of the Rh...

Page 13: ...grounding connections that match the receptacles in your location 6 OPERATION 6 1 Cautions WARNING HVHA technology is radically different than steam sterilization and conventional practices associated...

Page 14: ...he treatment chamber to assure full airflow to the masks 6 2 3 Before Running Your First Decontamination Cycle Before turning the RH N95 on open the door and visually inspect the heating chamber Clean...

Page 15: ...be decontaminated in the RH N95 6 3 2 Pre set N95 Cycle The RH N95 is equipped with a pre programmed decontamination cycle representing the time and temperature required to achieve a 6 Log reduction...

Page 16: ...masks can be partially nested as shown below with up to 10 12 depending on mask size masks per tray without impeding temperature transfer to the mask assuring conditions are achieved for required vir...

Page 17: ...the chamber to 174 F The process is initiated upon starting the unit see above indicated by Preheating Once this temperature has been obtained the screen will indicate READY followed immediately by th...

Page 18: ...nto the USB port at bottom of front right panel which indicates that the CIR has been initialized for the next reprocessing cycle The screen also reminds the operator to push the button on the CIR log...

Page 19: ...ults in the following screen sequence The interruption of the decontamination cycle is noted in memory A new decontamination cycle can be initiated by pressing START on the READY display 2 Plugging in...

Page 20: ...selected i e if the device were displaying Pacific time of 05 00 pm setting the time zone to Eastern time would change the displayed time to 08 00 pm If you set the time prior to setting the time zone...

Page 21: ...B port The screen will display Flash Drive Ready Press MENU from READY or HEATER IS OFF screen to display SELECT ITEM screen Press SOFTWARE UPDATE The file will be downloaded in seconds Follow loading...

Page 22: ...ons on the screen for attribute selection Once the option is selected the screen reverts to the CONFIGURATION listing screen If no more changes are to be made press DONE to return to READY screen 6 3...

Page 23: ...95 masks The temperatures are 200 F lower than the RH Pro11 medical instrument sterilization cycles No chemical indicator has been developed for this cycle A better and more direct approach has been t...

Page 24: ...battery life will not be affected WARNING Handle lithium metal batteries carefully observe warnings on battery casing Dispose of in accordance with local regulations CIR Battery Replacement 8 0 MAINTE...

Page 25: ...ad limit is 200 mA about 1 10 the output power of a typical USB wall pluggable charger The RH N95 USB jack is not intended for use in recharging USB connectable devices such as cell phones The unit wi...

Page 26: ...operating manual Epson TM U220B Printer The date and time should be set on the unit so that information in the data log is correct as to time These settings should be performed before the RH N95 is f...

Page 27: ...in 04 33 172 164 7 min 04 34 172 165 8 min 04 35 172165 9 min 04 36 173 165 10 min 04 37 173 166 11 min 04 38 173 166 12 min 04 39 173 166 13 min 04 40 173 166 14 min 04 41 173166 15 min 04 42 173 166...

Page 28: ...Unlocking Handle not locked or misaligned WARN Clear Error Latch handle fully vertical Chamber Overheating Main PCB or Thermocouple Malfunction WARN ERR Attempt to Clear Contact Authorized Service Te...

Page 29: ...hamber Capacity 2294 cubic inches 10 gal 38 liters Instrument Tray ID 9 229mm W x 15 381mm D x 1 28mm H Instrument Material Compatibility Check Web Site for List of Compatible Materials Decontaminatio...

Page 30: ...buse tampering and neglect nor shall this Warranty extend to equipment that has been repaired or altered outside of CEI s factory without prior authorization from CEI In addition CEI assumes no respon...

Page 31: ...ement of the warranty terms The parties agree that the Customer s sole and exclusive remedy against CEI shall be for the replacement or repair of CEI equipment and or components and that no other reme...

Page 32: ...released its guidance document entitled Enforcement Policy for Sterilizers Disinfectant Devices and Air Purifiers During the Coronavirus Disease 2019 COVID 19 Public Health Emergency FDA1 which provid...

Page 33: ...arm up more precisely maintains plenum temperatures minimizes temperature over and under shoot and speeds heater element response to provide the temperature control necessary for this process The on b...

Page 34: ...RS Co V Rabenau et al Rabenau et al noted that heat treatment at 56 C for 30 minutes reduced a 7 Log10 SARS virus concentration to below the detection limit Processing at 60 C for 30 min resulted in n...

Page 35: ...emperature inactivation data derived from this model is shown in Table I adapted from Yap et al Table I Temperature Average Coronavirus Sterilization Time 6 Log10 Maximum Human Coronavirus Sterilizati...

Page 36: ...sity which reported that after the N95 filtration fabric was dry heat treated at 75 C for 30 minutes after 20 cycles there was no change in filtration efficacy or pressure drop Whole mask studies afte...

Page 37: ...and air purifiers during coronavirus disease utm_campaign 2020 03 29 20FDA 20Issues 20New 20Enforcement 20Policy 20for 20Sterilizers utm_medium e mail utm_source Eloqua FDA2 Enforcement Policy for Fac...

Page 38: ...rature Dependent Inactivation of Coronaviruses April 21 2020 https chemrxiv org articles A_Predictive_Model_of_the_Temperature Dependent_Inactivation_of_Coronaviruses 12152970 1 Zhou S S et al Carrier...

Page 39: ...of the Rh N95 are o Access for inspection and cleaning of the ventilation air filter o Access for operation of the main power switch o Clearance for entry and exit of RH N95 ventilation air If your i...

Page 40: ...ame as no pullout installation as shown in Fig 1 above Simplifies access for filter and switch still need airflow ventilation o If open back clearance needed top sides need to access filter and power...

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