()()

()()

1953 1953

H2OCH4NH H CONH3 H2CO

()()

10% % 15%2%DNARNADNARNA

(Plasma) --

(Plasma)

-

+

+

-

+

99%

H O ()H2O2 ()

H O H2O2-

HH22OO22

/ 2 2

H O H2O2-

H2O2 2 2,

.

, . . .

H2O2-or

OHOH--

2 2

oror or(peroxide molecule) (hydroxyl (hydroxyl (OH-))

(peroxide molecule) (p )Hydroperoxyl (OOH-) molecule & hydrogen atom (H)

OOHOOH--& hydrogen atom (H)

ultra-violet (UV) light

HH

H O -

H2O2

.......

HH22OO22HH22OO

OO22. . .

water (H2O) and oxygen (O2). (O2). : :

STERRADSTERRAD

STERRADSTERRAD (H O )(H2O2)

,

STERRAD*STERRAD

8 1980 1982 1983,1983 1986 1987 1987, 1989,1991 FDA 1993 FDA 1993 Japan MOHW approval 1994 ISO 9001, CE Certification (TUV) 1995 ISO 9001, CE Certification (TUV) 1995 Intermedica Prize (France) 1995

STERRADH2O22O2

: () Plasma ()

4

H2O2 2 2

,

45O~50O

SAL = 10-6

STERRAD NX H2O22 2

1: 5: 1: (Vacuum)

5: (Vent)

5

2: 4:5

(28 or 38) 2: (Injection))

4(Plasma)

(28 or 38)

3: (Diffusion)

STERRAD Plasma Sterilization

ConsumablesASP th i t f lASP the inventor of low temperature hydrogen peroxide plasma sterilization technologyp gy

STERRAD Sterilization worldwide safe, proven and

STERRAD 100S

STERRAD 200STERRAD 50 STERRAD NX

, pexperienced plasma technology

STERRAD 100 STERRAD 200STERRAD 50 STERRAD NX

1992 1996 1999 20051997

STERRAD 100NX S t O iSTERRAD 100NX System Over view

H O H2O2

:1.

2.:3.4.

5.6.7 7.

H O H2O2

::11 1.1.2.:2.:

3.

4 4.5.6. 7.

SpauldingClassification(1968)

MedicalDeviceMedicalDeviceSterilityAssurancey

ASPsMedicalDeviceManufacturerTeam ASP sMedicalDeviceManufacturerTeammdmprogram@its.jnj.com

MDMTestingProgrammdmprogram@its jnj commdmprogram@its.jnj.com

STERRADSterilityGuide(SSG)STERRAD SterilityGuide(SSG)www.sterradsterilityguide.com

1 Instr ment preparation1. Instrument preparation Disassemble instruments according to the

manufacturers Instructions for Use (IFU). Remove allmanufacturer s Instructions for Use (IFU). Remove all blood, tissue and soil from instruments using an enzymatic detergent per the manufacturers IFU. Rinse y g pthe instruments thoroughly to remove any residue.

Dry all items completely and inspect each instrument forDry all items completely and inspect each instrument for proper function. Moisture on instruments will lead to cancellation of the cycle. Medical grade compressed aircancellation of the cycle. Medical grade compressed air may be used to help dry lumens and other hidden spaces.p

I t t k i I2.Instrumentpackaging:I

Instruments can be packaged for sterilization utilizing different methods.different methods.

APTIMAX Instrument Trays are recommended for use in the STERRAD System as they have been designedin the STERRAD System, as they have been designed to allow optimal diffusion of hydrogen peroxide gas around all items in the load Use APTIMAX Instrumentaround all items in the load. Use APTIMAX Instrument Tray Holders to secure instruments in the trays. APTIMAX Instrument Trays can be enclosed in eitherAPTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators.

A th tArthroscopyset

Cystoscopy set Hysteroscopy set

2 Instr ment packaging II2. Instrument packaging: II Container systems tested and cleared for use in

STERRAD Systems, such as ASP SteriTiteSTERRAD Systems, such as ASP SteriTite Containers,* may be useful for processing typical instrument sets.

Place a STERRAD Chemical Indicator (CI) Strip inside each container system or tray prior to wrapping toeach container system or tray prior to wrapping to provide confirmation that the instrument has been processed.processed.

I t t k i III2.Instrumentpackaging:III

Iftheinstrumenttrayhasbeenwrappedinpolypropylenewrap,securethewrapwithSTERRADSEALSURETape.wrap,securethewrapwithSTERRAD SEALSURE Tape.ThetapecolorwillchangefromredtogoldChemicalIndicator(CI)orlighterduringthesterilizationcycle,( ) g g y ,indicatingthatthetrayhasbeenexposedtohydrogenperoxide.p

Singleinstrumentsmaybeplacedinpeelpouches,enablingeasyidentificationofpouchcontents.Peele a g easy de ca o o pouc co e s. eepouchesshouldnotbeplacedinsidewrappedtrays.

I t t k i IV2.Instrumentpackaging:IV

TyvekPoucheswithSTERRADChemicalIndicatorsaremadeofTyvek,whichispermeabletohydrogenperoxidemadeofTyvek ,whichispermeabletohydrogenperoxidevaporandprovidesamicrobialbarrier.

ASTERRADChemicalIndicatorStripshouldbeplacedASTERRAD ChemicalIndicatorStripshouldbeplacedinsideeachpouch.

WritingthecontentsontheSTERRADSEALSURE WritingthecontentsontheSTERRAD SEALSURE ChemicalIndicator(CI)Tapemayassistwith

id tifi ti fth h t tidentificationofthepouchcontents.

L di th t ili3.Loadingthesterilizer

Multiplepeelpouchesshouldbeplacedonedgeinsideanuncoveredtray.Pouchesshouldbeplacedinthetraysouncoveredtray.Pouchesshouldbeplacedinthetraysothattheclearsideofonepouchfacestheopaquesideofthenextpouch.Asinglepeelpouchshouldbeplacedflatp g p p pontheshelfwiththeTyveksidefacingup.

Provideatleast1inch(2.5mm)ofspacebetweentheProvideatleast1inch(2.5mm)ofspacebetweentheelectrodeandthetopoftheload,1inchbetweenpackagesintheloadand1inchbetweentheelectrodeandthesidese oad a d c e ee e e ec ode a d e s desoftheload.Placetraysflatonthesterilizershelvesinasinglelayer.Donotstacktrays.g y y

D t th f ll iDonotprocessthefollowing

Itemsmadeofmaterialscontainingcellulose,suchascotton paperorcardboard linens hucktowels ascotton,paperorcardboard,linens,hucktowels,gauzesponges,oranyitemcontainingwoodpulp

Singleuseitems InstrumentswithlumensthathavenotbeenInstrumentswithlumensthathavenotbeencompletelydriedI di b i i l i i Itemswrappedinbarriermaterialcontainingpaper

Foampadsininstrumenttrays

Whenloadingthesterilizer,DOWhenloadingthesterilizer,DONOT:

Stack instrumenttraysStac st u e t t ays Placeinstrumenttraysonedgeinordertofitmoreitemsinthesterilizer

Insertthesterilizershelfupside down Insertthesterilizershelfupsidedown Configuretheloadsothatmetalginstrumentsareincontactwiththewallsordoorofthesterilizerdoorofthesterilizer

Instrument life -- Cutting edgeControl

Instrument life Cutting edge

Adson Ganglion Scissors

0 10.1 mm

STERRAD* - 30 - 30

Sterility Assurance Level (SAL)

SterilityAssuranceLevel(SAL) SterilityAssuranceLevel(SAL)

SAL 10x106SAL

SterilityAssuranceLevels66100000010000005544

1000001000001000010000

332211v

ivor

svi

vors 10001000

1001001010 11

0011o

f Sur

vof

Sur

v 101011

0 10 1 1/ 101/ 10--11--2233u

mbe

r um

ber 0.10.1

0.010.010 0010 001

1/ 101/ 101/ 1001/ 100

1/ 10001/ 1000--33--4455

Nu

Nu 0.0010.001

0.00010.00010 000010 00001

1/ 10001/ 10001/ 10,0001/ 10,0001/ 100 0001/ 100 000--55

--6600

0.000010.000010.0000010.000001

TimeTime

1/ 100,0001/ 100,0001/ 1,000,0001/ 1,000,000

00 Time Time Heat/Gas/ChemicalHeat/Gas/Chemical

(106)((

))

EO EO

3hrs~6hrs 24~47 20~25

12hrs

0 5~1hr

0.5~1hr

, ,

1

15hrs~18hrs 24~47 20~85

1. , ,

10,

2. , FDA

53~55 45~50 132~134

CDC,

CJD

1. NaOHNaOCl 1

CJD

(/

)

1341

2. (NX)

(Descending Order of Resistance to Germicidal Chemicals)

BACTERIAL SPORESBACTERIAL SPORES STERSTER

CJDBACTERIAL SPORESBACTERIAL SPORES

Bacillus subtilisBacillus subtilisClostridium sporogenesClostridium sporogenesMYCOBACTERIAMYCOBACTERIA

STERSTERHLDHLD

ILDILDMYCOBACTERIAMYCOBACTERIAMycobacterium tuberculosis var. bovisMycobacterium tuberculosis var. bovis

NONLIPID OR SMALL VIRUSESNONLIPID OR SMALL VIRUSES LLDLLDNONLIPID OR SMALL VIRUSESNONLIPID OR SMALL VIRUSESPolio virus rhinovirusPolio virus rhinovirus

FUNGIFUNGI

LLDLLD

FUNGIFUNGI

Trichophyton CandidaTrichophyton CandidaCryptococcusCryptococcus

VEGETATIVE BACTERIAVEGETATIVE BACTERIA

Pseudomonas staphylococciPseudomonas staphylococcienterococci (MRSA, VRE)enterococci (MRSA, VRE)

LIPID OR MEDIUMLIPID OR MEDIUM--SIZED VIRUSESSIZED VIRUSES

HBV, HIV, HSV, HCVHBV, HIV, HSV, HCVEBOLA CMVEBOLA CMV

1 1. ---

2. ()

3. --

H O H2O2

::1 1.

2.2.::2.2.::3.

4 4.5.6. 7 7.

DoubleDoorOptionDoubleDoorOption

O Oneway

H O H2O2

::1

50C241.

2.:

4

33..4 4.5.6. 7.

24~42 --

40

H O H2O2

::1 1.2.:

3.

44 44..5.6. 7.

5 10 10 15 5~10 10~15

26~28 5 26 28 5

10~15

5

31~38 30~40

EO H2O2

(50)

2 4 2,000,000 1 500,000 1,500,000

2 4 2,000,000 1 500,000 1,500,000

EO24

2 4 2,000,000 1 500,000 1,500,000,,

2 4 2,000,000 1 500,000 1,500,000

2 4 2,000,000 1 500,000 1,500,000

,,, , , , ,

2 4 2,000,000 1 500,000 1,500,0004~6

12,000,000 3,000,000 9,000,000

1 O24 1. EO24,,,,, , ,4~6

2 62. , 6, ,,,, ,,

H O H2O2

::1 1.2.:

3.

4.4.

55..6. 7 7.

:Justintime EO/:EO/: :7~14 :

Tyvek1. 2. 3 3. 4.

H O H2O2

::1 1.2.:

3.

4.4.5.

66 66. . 7.

FDA 106()

1.(FDA)( )2.(MOHW)

H O H2O2

::1 1.2.:

3.

4.4.5.6 6.

77..

N t kC ti itNetworkConnectivity Customershavetheoptiontoconnect

theirSTERRAD100NXSystemtoaremotePCornetworkviaanEthernetremotePCornetworkviaanEthernetconnectiononthesterilizer.

Abilitytoelectronicallymaintaincyclerecordsanddownload&viewyonesecondcycledata.

Allowsforeasyuploadofinstrumentinventorytocreatemenuforloadentrydatalist Eliminatesneedtoentrydatalist.Eliminatesneedtohandwriteloadlist.

I d d tM it i S tIndependentMonitoringSystem IMS ISO14937 6.3.4 AnOptionalIMSisavailable.p

AnIMSisacombinationofprocessmeasurementinstrumentation,softwareandrecordingdevicethatduplicatesthesterilizercontrolsysteminstrumentationduplicatesthesterilizercontrolsysteminstrumentation.

Thereare9sensorsincludedintheIMSkit.Thereare9sensorsincludedintheIMSkit. 3sensorsmonitorpressure,5monitortemperatureand1monitorsplasmapower.

IMS 9 35 1

1.:

1 ISO90011.ISO90012.TUVCE)

3.(Intermedica Prize)

2.:,

3.EO/FO

CASNo.:00075-21-8:(Ethylene oxide)

:1., 2.

:1.,

2 : 3.4.

2., 3.,,4.:

CASNo.00050-00-0:( F ld h d )

:1.

:1., ( Formaldehyde)

:2., 3. ,,

2.,,3.4.

5.:

CASNo.:00064-17-5 : :: (Ethyl Alcohol) :

1.2.,,

1.,

2., :

164: ,:,

EO()1,2 FO() 2 3 FO() 2,3

:

()

( )

(EO)(EO)

, CFC,,HCFC,ETO,FO:

ISO/TC MOHW : ISO/TC194.MOHW,EtO

: 1ppm.EtOFO. 1995 EtO.995

: EO,99.9%EO.OHSA1ppm ,5ppm/15minutes

: EO (1994)

: EO(1995): EO(1995) : CFC(1995) HCFC(1999) 450

EO 6 EtO 8 : EO1ppm.1995 65EtO,1998 30.

:EO (1997,4)

3 :H2OO2,3. :H OO EO

STERRAD* H2O2STERRAD* H2O2

()H2O + () O2

()H2O2

H O H2O2

:: - 24 - - ,, - &

() (Mechanical Monitor)() (Mechanical Monitor)

() (Chemical Indicator)() (Chemical Indicator)

() (Biological Indicator)( ) ( g )