CPAC RapidHeat RH-N95 Скачать руководство пользователя страница 35

35   

   

are   adequate   to   fully   inactivate   the   coronavirus   (>6   Log

10

   reduction)   at   an   exposure   of   30   minutes   

without   damage   to   mask   components   or   to   the   mask’s   performance.   Significant   inactivation   of   MERS   
Co-­‐V    has    also    been    reported    by    Leclercq    et    al.    at    65°C    for    an    exposure    at    15    minutes    (>    4    Log

10

;   

below   the   limit   of   virus   detection.).   Darnell   et   al.   found   similar   results   with   SARS-­‐CoV   with   >   5   Log

10

   

at   65°C   for   a   10-­‐minute   exposure.      
   
Although    all    the    above-­‐cited    viral    references    were    conducted    in    heated    liquid    suspensions,    it    has   
been   shown   by   Zhou   et   al.   in   a   comparison   of   dry   heat   inactivation   on   solid   surfaces   versus   liquid   
suspensions,    an    equivalency    of    inactivation    at    65°C.        This    study    supports    the    inactivation    data   
gleaned   from   liquid   suspension   studies   may   also   be   comparable   for   solid   carrier   inactivation   rates.   
   
In   a   recent   report   conducted   thought   the   Department   of   Mechanical   Engineering   at   Rice   University   
(Yap    et    al.)    a    thermodynamic    model    for    dry    heat    inactivation    is    presented    which    has    synthesized   
data    from    peer-­‐reviewed    literature    to    accurately    predict    temperature-­‐dependent    inactivation    of   
Coronaviruses.   This   paper   states:   “virus   inactivation   occurs   primarily   due   to   thermal   denaturation   of   
the    proteins    that    comprise    each    virion.”    Using    published    data    from    dry    heat    inactivation    studies,   
their   model   demonstrated   that   inactivation   is   indeed   “a   thermal   denaturation   process,   inactivated   by   
thermally-­‐driven    protein    denaturation.”    Time-­‐temperature    inactivation    data    derived    from    this   
model   is   shown   in   Table   I   (adapted   from   Yap   et   al).   
   

Table   I   
   

Temperature      

Average   

Coronavirus   

Sterilization   Time,      

6   Log

10   

Maximum   Human   

Coronavirus   

Sterilization   Time,      

6   Log

10

   

Average   Human   

Coronavirus   

Sterilization   Time,      

6   Log

10

   

60°C   

48   min   

9   min   

8   min   

80°C   

3   min   

<   1   min   

<   1   min   

   
   
This    data    supports    the    work    presented    above    for    similar    time-­‐temperature    parameters    and    the   
study   by   Zhou   et   al.   in   which   no   differences   were   found   between   solid   surface   and   liquid   suspension   
inactivation   of   viruses   at   65°C.   
   
Similarly,   data   supports   that   Mycobacteria   is   very   heat   sensitive   requiring   only   a   few   minutes   at   60-­‐
65°C    for    complete    inactivation    (Sung    and    Collins,    Hammer    et    al.,    Grant    et    al.,    Keswani    and    Frank).   
Literature    searches    have    demonstrated    that   

Mycobacterium    paratuberculosis

,    can    be    inactivated    in   

solution   to   a   >   6   Log

10

   reduction   in   6   minutes   at   65°C   (149°F)   and   at   68°F   (155°C)   in   2.2   minutes.   

Mycobacterium

   

paratuberculosis

    is    more    thermally    resistant    than   

M.    bovis

,    the    heat-­‐resistant   

surrogate    designated    for    Mycobacterium    challenge    inactivation    studies.    The    time-­‐temperature   
profiles   selected   for   N95   mask   re-­‐processing   exceed   those   profiles   required   to   inactivate   >   6   Log

10

   

reduction   of   Mycobacterium.   
   
This   dry   heat   process   does   not   use   any   chemicals,   using   only   low-­‐temperature   air   at   high-­‐velocities   
to   decontaminate.   Organic   residues   residing   on   a   used   mask   do   not   significantly   impede   the   delivery   
of   heat   to   microorganisms   nor   affect   the   inactivation   efficacy   of   this   process.   The   low   temperatures   
used   in   this   process   do   not   affect   the   material   integrity   or   composition   of   the   N96   masks   tested   to   
date.   
   
   
   
   

Содержание RapidHeat RH-N95

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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