united states environmental protection agency · 1995. 8. 2. · .2 iii ). 2 a stamped copy of the...
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
ProChem company A Wholly Owned Subsidiary of Cottrell, Ltd. 7399 South Tucson Way Englewood, CO 80112
Attention: John R. scoville, Jr.
Subject: Omnicide Liquid Disinfectant EPA Registration No. 46851-2
AUG 2 1995
Letters Dated July 10, 1995 and July 13, 1995
The container labeling and package insert labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Acts, as amended, are acceptable, provided that you make the labeling changes listed below before you release the product for shipment bearing the amended label.
1. On the container Labeling:
a. The "Virucidal" claim must be keyed by a symbol to the paragraph listing the specific tested viruses.
b. Specify the major areas in which the product is recommended for use (e.g. homes, school, hospitals)-
c. Delete the term "ProCide" wherever it may appear on the label. This is not your product name.
2. According to our records, there is a contradiction concerning the name of this product. The name on file is "omnicide Liquid Disinfectant" and not "omnicide sterilization and Disinfecting Solution". Please clarify.
3. You are reminded that the container labeling must meet EPA's current labeling requirements.
::::.! .. ....-.... ............ ··1 ··_··· ... ·_··t··:·:::·:::r-..... _ ... ··, ...... _·- ._-1" ............ 1-. __ ...... _. O"TE '~ .................. ••••••••••••••••• .... ............. ................. ................. ................. • •••• ~ ........ - ................. .
OFFICIAL FILE COpy EPA Form 132()'lA (1/90) Prinltd 011 Rtcycltd Papa Ie uS GOVFHNMENT PR1NT!NG OFf It:!: I~J5 &19457
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A stamped copy of the labeling is enclosed for your records. submit one (1) copy of the final printed label prior to release of the product for shipment.
If you have any questions concerning this letter, please contact Martha Terry at 703-305-6982.
Enclosure
Sincerel,,--,,-v~
Marion J. Johnson, Jr. Product Manager (31) Antimicrobial Program Branch Registration Division (7505C)
+-
INTWO(o USE
Sterllllatlon: This soltl\Jon !'.hould be used lor 11m ~1r.II!if;l.liuTl 01 heal sensitive IIlcdiVlI 1'!lllIllllur.nl lOt wluch allr.rnahvc method!:. of !,1r:rili, .. tll'lt1 fife 1101 suilable. Medical r.qllipmr.ol whlth !>h(lU\fl alway!. llc SI(lli!llCd is thai winch 1<; r ... 1Irijori/~11 a!; uilir.ai (n.n • lI'icd in procedures III whir.h (.o!'llar.! will he mail!'! wilh li~5Ur. lhal is 1101111,\11'; (tlll~.nlt;lcd sl!'!!!I!!.)
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pnECAUTIO~ARY STATEMENTS IIAZARDS TO IIUf~ANS AND DOMESTIC ANIMALS
DANGER: Keep QU\ 01 Rellth of r.htldlt.l1. Dircel COIII.1cl may ~usr. eye damage ami \lun inita!ionlrullnanr.. 00 :101 (Jet iulu r.yrs. on M:in ot on clr.tltinO Wear gOOQlc$ Of lacc $!Iield ;11111 IIIhhr.1 1110'1(':<; \'Ihen h;mdbll!J ("It plltJftll!] Avnlll CIInlatninalion ("11100(1 Uo;.r. In writ \'('1IJo1Jlt:tl Jt('a in (J()~r.rl r.rJtll;:t.inr.l~
STA1[I~ENT or pnACTICAl lIlEATM[NT. In r~lSr. 01 cOlllitcl. imll1r.dl;:t.I~1y lIu~.h n)·c~. Of
sktO willi COllIOlIo; am(lunl~ or "'';Itef fnr al r.'Ol'i1 15 minutf's. For (W~s. gr.! rnr.di(:.11 <t1lE'.r.lion UfUmlul if swalJowcd Orink IfUQI'! qu;ullilir." 01 'I't~fp.r ilnd call a plrV$ltiilll immr.dlalefy
NOTE TO PIIYSIC)AH: p,ol}ablc 11lur,osi\1 (\amagc hom or.t1 ~lflOSlJrp. may r.Ohll<lirnlicalc lhe lise of ga<;.hic "v.1Qc.
STORAGE AND DISPOSAL
Slore al conlrolled fOom lr.mllCIi\lmc IS"C·JD·CIS9"·86"fj Pesticide OIspoul: 0,<,('..-:1,,1 1r.~.idu;JI",ol.'!lon in drttin. FlU5h tltnlO1tghlYVllih w,llel Container Disposal: 00 nollt::n~,e r.1ll111y r.olll.tmt:r \'1'.111 cnnl;:t.inCI al\d pulln II,,-<;f'
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Long Life Reusable Acliv;
Sterilizing and Disinfectir
Sporicidal, Virucidal, Fungici Bactericidal, Tuberculocidal
Acliv.lngredler.1 Glutaratdehyde Inert Ingredient TOTAL
2.4% 97.6%
100.0%
E P.A. RcglStration No 46851"2 E P.A Esl,lJlisllmcnT No. 37255·CA·Ol E PA Esla~I'shment No 39754·WI-1 (Sec shoulder 01 conlalner lor E PA Est No)
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BEST COP'{ AVA\LABLE
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. ACCEf'fIW wlth co'"
I " """""r~ :J LPA .< .. , '" Letter V'lt.d:
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Omnicide™ activated dialdehyde solution is a liquid chemical sterilant and a high or
intermediate level disinfectant when used according to the Instructions for Use.
1. Germicide Level of Activity: Omnicide™ can be used at the following gennicide
levels of activity:
Sterilallt: Omnicide™ is a sterilant when used or reused, a;;cording to the Directions
For Use, at or above its Minimum Effective Concentration (MEC) as determined by
the ProChek G Glutaraldehyde Concentration Indicator Test Strip at 68°F (20°C) with
an immersion time of ten hours for a use period not to exceed 28 days.
High Level Disinfectant: Omnicide™ is a high level disinfectant when used or
reused, according to the Directions for Use, at or above its Minimum Effective
Concentration (MEC) as determined by the ProChek G Glutaraldehyde Concentration
Indicator Test Strip at 68°F (20°C) with an immersion time of 45 minutes for a use
period not to exceed 28 days.
Intermediate Level DisilJfectanl: Omnicide™ is an intermediate level disinfectant
when used or reused, at or above itsMinimum Effective Concentration (MEC) as
determined by the ProChek G Glutaraldehyde Concentration Indicator Test Strip at
68°F (20°C) with an immersion time of ten minutes according to the Directions for
Use in Section E for a use period not to exceed 28 days.
A ten minute immersion at 68° F (20° C) will destroy all vegetative bacteria including
S. aureus, S. choleraesuis, P. aeruginosa, E. coli, all pathogenic fungi, representative
viruses and 99.99% of Mycobacterilllll strains' CQuantitaHve 1'8) as •. represei~ted by bovis and terrae.
Cottrell 510(k) K932922 Response 6/29/95
ACCEP'l'l!lO Vlith COMME~"T8
1:1 £i'.\ 4ttcr D3~
J\UG .~
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2. Reuse Period: Omnicide 1M has demonstrated efficacy in the presence of 5 percent organic soil contamination and a simulated amount of microbiological burden during
reuse. OMNICIDETM SOLUTION MAYBE REUSED ONLY WHILE THE MINIMUM EFFECTIVE CONCENTRATION (MEC) AS DETERMINED BY THE PROCHEK G GLUTARALDEHYDE CONCENTRATION INDICATOR TEST STRIP, PH AND TEMPERATURE MEET THE REQUlREI\-IENTS BASED UPON MONITORING AS DESCRIBED IN INDICATOR DIRECTIONS
FOR USE. Efficacy of Omnicide™ solution during its use-life must be verified by the ProCheK G Glutaraldehyde Concentration Indicator Test Strip to determine that at least the MEC as determined by the ProChek G Glutaraldehyde Concentration Indicator Test Strip is present. The product must be discarded after 28 days.
3. General Information: Choose a germicide with the level of microbial activity that is appropriate for the reusable medical device or equipment surface. Follow the reusable device labeling and standard institutional practices. In the absence of complete instructions, use the following guidance:
First, for patient contacting devices, determine whether the reusable device to be processed is a critical, semi-critical, or non-critical device.
• A critical device routinely penetrates the skin or mucous membranes during use or are otherwise used in normally sterile tissues of the body.
• A semi-critical device makes contact with mucous membranes but does not ordinarily penetrate sleIile areas of the body.
• A non-critical device contacts only intact skin during routine use.
Second, determine if sterilization, high level or intermediate level disinfection is
required.
Critical device: Sterilization is required.
Semi-critical Device: Although sterilization is recommended whenever practical,
High Level Disinfection is acceptable (e.g. GI eTido'scQP¥?~:~nesthe~ia equ~tment to be used in the airway, diaphragm-fitting rings, etc.) . ~- .. ~ . i
Cottrell 510(k) K932922 Response 6/29/95
" ACCEPTfo:D l , 1'.1,'1 Com'"".".., , I;) E'>' .",.,"~
. • .. Lettcl' llalcd:.. , • :, ~ .' ,
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Non-critical device: Medical Equipment Surfaces: Intermediate level disinfection is recommended.
Third, determine the time required to achieve the level of disinfection or sterili1.ation required for the specified medical device.
4. The gennicidal activity of Omnicide™ was demonstI3ted using stressed solutions* in
performance, clinical and simulated use testing using the following organisms:
Organisms
Spores
• Bacillus subtilis
• Clostridium sporogenes
Vegetative Organisms
• Staphylococcus ameus
• Salmonella choleraesuis
• Pseudomonas aeruginosa
• Escherichia coli • Mycobacterium bovis
Funoi b
• Trichophyton interdigitalc
Non-lipid Small Virus
• Polio 2
Lipid Medium Virus
• Herpes simplex
• HIV-I (AIDS Virus)
Onmicide™ Disinfection Times
10 hours
45 minutes
10 minutes
10 minutes
10 minutes
60 seconds at full strength
~""'.' ..
.1 I ',.-.... "J ,-t',:U .
* Testing was performed using Omnicide 1M solution which h"d been diluted to 1':percent using 5 percent bovine calf serum.
Cottrell 510(k) K932922 Response 7/12/95 - Correction of AIDS Claim 1",°" '\ ( 1:'> .....
, , . .. '
5. Material Compatibility: Omnicide™ solution is recGilunended for usage with
medical devices made from the materials shown below.
polypropylene
ABS
polyethylene*
polycarbonate
black oxide steel*
Mylar*
vinyl and Tygon tubing**
nickel plating"
acrylic bar*
polyethylene tubing*
PVC*
*represents four weeks of exposure
**represents 13 days of exposure
Following sterilization or disinfection, the sterilized or disinfected medical device
should be rinsed according to the Instruction for Use, Rinsing (Section E.4), and dried
according to manufacturers instructions.
6. Pre-cleaning Agent Compatibility: Omnicide™ IS compatible with enzymatic
detergents which are neutral In pH, low foaming and easily rinsed from equipment.
Detergents that are either highly acidic or alkaline are contraindicated as precleaning
agents since improper rinsing could effect the efficacy of the Omnicide ™ ~ol\ltion by
altering its pH.
B. CONTRAI~1)ICATIONS
1. Sterilant Usage: Routine biological monitoring is not possible with OlllIlicide TM
solution and therefore Omnicide™ solution should NOT be used to sterilize reusable
medical devices that are compatible with other sterilization processes that can be
biologically monitored.
Omnicide™ solution should not be used for sterili7.at;on of critical devices intended
for single usc (e.g. catheters). .. ".. - --... - .;:~." -.~~
Cottrell 51O(k) K932922 Response 6/29/~)5
. ACCEP1'Gt} With C'O!~~\JF.!\~S
in F-I'A l,.cU"r D~tClf: ' .
1::;':J I' L' •• ,... .~' t. ", i, ..• -! ::.-ic~~ k .. " I ,- ", f;'" ,
: .,'.. • . ., d·Wf.! .U(r .. , ,h.t r .... ". r -._'.I, (Ill' ~i;(> I!l· ... •.· :')0 t·,·:· .• · •.. ·.· ,,"'f> ""' •• '
. ', .. I l .• I'I.!' h. A nt1'f '1., Pane-1 if. / o· "Q. '<> .~ .. -.... ..If.~~'£L- -:l "2,g,-
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2. High Level Disinfectant Usage: Omnicide™ solution should not be used to hi~h
level disinfect a semi-critical device when sterilization is practical.
3. Endoscope Usage: Onmicide™ solution is not the method of choice for steriliz.1tion
of rigid endoscopes which the device manufacturer indicates are compatible with
steam stel ilization.
C. WARNINGS
OiviNICIDpM ACfIVATED DIALDEHYDE SOLUTION IS HAZARDOUS TO
HUMANS AND DOMESTIC ANIMALS.
DANGER: Kcep Out of Reach of Children
Contains Glutaraldehyde
1. Direct contact is corrosive to exposed tissue, causing eye damage and skin irrita
tion/damage. Do not get into eyes, on skin or on clothing.
2. Avoid contamination of food.
3. Use ill well ventilated area in closed con:ainers,
In case of contact, immediately flush eyes or skin with copiolls amounts of water for at
least 15 minutes. For eye.s, get medical a!lention.
Harmful if swallowed. Drink large quantities of water and call a physician immediately.
Probable mucosal damage from oral exposure may contraindicate the use of gastric
lavage.
Emergency, safety,.or technical information about OIfmicide™ solution can be obtain~d
from Cottrell, Ltd. Hotline at 1-800-843-3343, or bywntacting Chcmtrac at80Q,;?;},,'i-51)53
or by contacting your local Cottrell, Ltd. representative.
Cottrell 5 :O(k) K932922 Response 6/29/95
_. _ .... -. , ACCi~pnm
wi:h COmlE~'T3 I:. E P <\ LrUor Date\!:.
'II,', .) .. ,I •• 1 ~
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Page 5
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D. PRECAUTIONS
I. Appropri~'te hand, eye and face plOtection as well as liquid proof gowns should be
worn when cleaning and sterilizing/disinfecting soiled devices and equipment.
More detailed information regarding the handling of the products along Wilh
compatible materials is included in the MSDS sheet attached to the product container.
2. Contaminated, reusable devices MUST BE THOROUGHLY CLEANED prior to
disinfection or sterilization, since residual contamination will decrease effectiveness
of the germicide.
1 The user "'IUST adhere to the Directions for Use since any modification will afiect
the safety and effectiwness of the germicide. "'.- ..
." """
4. The reusable device manufacturer should provide the user with a validated ~ ACCBFii'iD
reprocessing procedure for that device using Omnicide™ solutiOll. bill! COi\B1E!I."l'S lil EPA Leller Datelf:
E. DIRECTIONS FOR USE
I. Activation L.,: ..... ;·:.~)~·,:·): .. ··.i;~·:'.}~ .... .: - •• ~. L· ...... i E!:l\ 1'1'" ;\.0. Lf •. , .. ,
Activate the Omnicide™ solution by addir,g the entire contents of the Acti'VfltJ:~~ (which is auached to the Omnicide™ solution container) to the container. Place cap
on container and shake well. On activa:ion, the solution immediately changes color
to bille, thereby indicating solution is ready to use. The solution should then be
immediately te~1ed with the Prochek G Glutaraldehyde Indicator Test Strip upon
activation and prior to each use to assure glutaraldehyde concentration is above the
MEC. Omnicide ™ solution is intended for us~ in manual (Lucket and tray) systems
made from polypropylene, ABS, polyethylene, glaso-filled polypropylene or specially
molded polycarbonate plastics. Record the date of activation (mixing date) and the
expiration date on the Omnicide™ solution container label in the space provided, as
well as in a log book or a label affixed to any secondary container used for the
activated solution. Omnicide™ must be discarded after 28 days, even if the
ProChek G Glutaraldehyde Indicator Test Strip indicates pass.
Cottrell 51O(k) K932922 Response 6/29/95 Page 6
, , I
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2. Cleaning/Decontamillation
Blood and other body fluids must be thoroughly cleaned from the surfaces, lwnens,
and objects before application of the disinfectant or sterilant. Blood and other body
fluids should be autoclaved and disposed of according to all applicable federal, state
and local regulations for infectious waste disposal.
For complete disinfection or sterilization of medical instruments and equipment,
thoroughly clean, rinse and rough dry objects before immersing in Omnicide™
solution. Cleanse and rinse the lumens of hollow instruments before filling with
Omnicide™ solution. Refer to the reusable device manufacturers labeling for
instructions on disassembly, decontamination, cleaning and leak testing of their
equipment.
3. Usage
It is a violation of the Federal Law to use this product in a manner inconsistent
with its labeling.
a. Sterilization (Bucket[frav Manual System)
Prior to immersing medical equipment/devices, test the solution with a ProChek G
Glutaraldehyde Indicator Test Strip to assure that the glutaraldehyde concentration
is above its MEC.
Immerse medical equipment/devices completely in Omnicide™ Solution for a
minimum of ten hours at 68°F (20°C) to eliminate all microorganisms including
Clostridium sporogenes and Bacillus subtilis spores. Remove equipment from the
solution using sterile technique and rinse thoroughly with sterile water following
the rinsing instructions below.
Cottrell 510(k) K932922 Rcsponse 6/29/95 Page 7
b. High Level Disinfection (BucketITray Manual System)
Prior to immersing medical equipment/devices, test the solution with a ProChek G
Glutaraldehyde Indicator Test Strip to assure that the glutaraldehyde concentration
is above its MEC.
Inunerse medical equipment/devices completely in Omnicide™ solution for a
minimum of 45 minutes at 68°F (20°C) to destroy all pathogenic
microorganisms, except for large numbers of bacterial endospores, but including
Mycobacterium tuberculosis (Quantitative TB Method). Remove devices and
equipment from the s0lution and rinse thoroughly follo~WlL the. rinsing inl>1mctions below.
c. Intemlediate Level Disinfectant . j ,
ACGEPTFiD with C01IME~'TS,
In :f;P 1I J,ctter Dat~ .. '.\ I" : J\til) l
Prior to immersing medical equipment/devices, test the solution with a ProChek G
Glutaraldehyde Indicator Test Strip to assure that the glutaraldehy?e.lfM~~.~~npK.;,.;.','~~;:;~~~ is above its MEC. ·U r.:"on<lc'.I, r',r "'0 i""'" id~
~ n-b4\~!:t:·.u.i uncl!..T EPA l:~g. ~';o.
1-=~~(/- ~~-Omnicide ™ is an intermediate level disinfectant when used or reused, at or above
its Minimum Effective Concentration (MEC) as determined by the ProOlek G
Glutaraldehyde Concentration Indicator Test Strip at 68°P (20°C) with an
immersion time of tcn minutes for a use period not to exceed 28 days.
4. Rinsing Instructions
Foliowing immersion in Omnicide™ solution, thoroughly rinse the equipment or
medical device by immersing in two gallons of water. Repeat this procedure a second
tillie with a fresh two gallon volume of water.
For endoscopic instmments with lumens, a rninimum of 500 ml of water should be
flushed through lumens during: each separate rinse unless otherwise noted by the
device or equipment manufacturer. Use fresh volumes of water for each rinse.
Discard the water following each rinse, Do not reuse the water for rinsing or any
other purpose as it will become contaminated with glutaraldehyde,
Refer to the reusable device/equipment manufacturers labeling for rinsing instmctions.
Cottrell 51O(k) K932922 Response 6/29/95 Page 8
J
,J-
Sterile Waler Rinse:
Critical devices which are sterilized with Omnicide 1M must be rinsed with sterile
water.
Potable Water Rinse:
A sterile water rinse is recommended when practical, for all devices. Alternatively,
a high quality potable water (one that meets Federal Clean Water Standards at point
of use) may be used.
The use of potable water for rinsing, increases the risk of contaminating the device
or medical equipment with Pseudomonades and atypical (fast growing) Mycobacteria
that are often present in potable water supplies. The devices (e.g. colonoscope) need
to be completely dried, because any moisture remaining provides an ideal situation for
rapid colonization of bacteria. Additionally, mycobacteria are highly resistant to
drying, therefore, rapid drying will avoid possible colonization but may not result in
a device free from atypical mycobacteria. A final rinse using a 70 percent isopropyl
alcohol solution should be used to speed the drying process and reduce the numbers
of any organism present as a result of rinsing with potable water.
F. REUSE
Omnicide™ solution has demonstrated efficacy in the pre.<;ence of 5 percent organic
soil contamination and a simulated amount of microbiological burden during reuse.
'I11e glutaraldehyde concentration of this product during its use-life must be verified by
the ProCheK G Glutaraldehyde Concentration Indicator Test Strip to determine the
solution is above the Minimum Effective Concentration requirement (MEC) as determined
by the ProChek G Glutaraldehyde Concentration Indicator Test Strip is present. TIlis
solution may be used and reused within the limitations indicated above for up to 28 days ,
after activation. Omnicide TM must be discarded after. 28 days •. eyeJljUll~)r.2.<;bek G .--.- .,,~~'-... _. _ ~f
Glutaldldehyde Indicator Test Strip indicates pass. . ~
.j ,
Cottrell 51O(k) K 932922 Response 6/29/95
ACCEPTF.-D with COlIMENTS
.:in EPA Letter DatEd;
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G. i\IONITORING OF GERMICIDE TO ENSURE SPECIFICATIONS ARE MET
It is recommended that the Omnicide™ solution be tested with the ProCheK G
glutaraldehyde test strip prior to each usage. This is to insure that the appropriate
concentration of ghltaraldehyde is present and to guard against a dilution which may
lower the concentration of the glutaraldehyde below its MEC. During the use of
Omnicide TM as a high level disinfectant and/or sterilant, it is also highly recommended
that a thermometer and timer be used to ensure that optimum conditions are met. The
pH of the activated solution may be periodically checked to verify that the pH of the
solution is between 8.0 and 9.0.
H. POST-PROCESSING HANDLING AND STORAGE OF REUSABLE DEVICES
Sterilized or disinfected reusable devices are either to be used immediately or stored in
a manner to minimize contamination. Refer to reusable device equipment manufacturers
labeling for additional storage and/or handling instructions.
I. STORAGE CONDITIONS AND EXPIRATION DATE
). Prior to activation, Ornnicide™ solution should be stored in its original sealed
container at controlled room temperature 15° -30° C (590 _86 0 F).
2. The expiration date of the unactivated Omnicide™ solution and activator will be found
on the side of the immediate container.
3. The use ;:>criod for activated Omnicide™ is for no longer than as indicated by
ProCheK G Glutaraldehyde Concentrdtion Indicator Test Strip or 28 days following
activation. Once activated, the solution requires no further dilution prior to its usage.
J. SAFETY INFORMATION
Emergency, safety, or technical information about Omnicide™ solution can be obtained '...... . ~
from Cottrell, Ltd. at 1-800-843-3343, Infotrac at 800-535'-5053, or.by sontactirig your
Cottrell, Ltd. representative. ,
I
Cottrell 510(k) K932922 Response 6/29/95
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Page 10
I I (
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K. USER TRAIN1NG
TIle user should be adequately trained in the de.contamination and disinfection or
sterilization of medical devices and the handling of liquid chemical germicides. Additional
infonnation about Omnicide™ solution can be obtained from Cottrell, Ltd. at 1-800-843-
3343, or by contacting your local Cottrell, Ltd. representative.
L. DISPOSAL INFORMATION
0.946 L (1 quart), 3785 L (I gallon), and 9462 L (2.5 gallon) size container must be triple
rinsed and disposed of in accordance with local or state regulations.
M. REORDER INFORMATION
I Reorder I Description
PCI032 0.946 L (1 quart)
PCI128 3.785 L (l gallon)
PCG660 Strips ProCheK G Concentration
r
Indicator
PCG615 ProCheK G Concentration
Cottrell 510(k) K932922 Response 6/29/95
I Case Contains
4 x 0.946 L (4 qts/case)
4 x 3785 L (4 gals/case)
, ,
";
60 strips/bottle
(6 blls/case)
15 strips/pkg
...... ~ ' ..
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OMNICIDETM LONG LIFE ACTIVATED DIALDEHYDE SOLUTION
PACKAGE INSERT
ENDOSCOPE REPROCESSING
DRAFI' LABELING
A. INTENDED USEflNSTRUCTIONS FOR USE
Omnicide TM activated dialdehyde solution is a liquid chemical sterilant and high level
disinfectant for flexible endoscopes when used according to the Instructions for Use.
1. Germicide Level of Activity: Omnicide™ can be used at the foilowir:g germicide
levels of activity:
Flexible Endoscopes, when expected to penetrate the sldn or mucous membranes or
are used in otherwise normal!y sterile tissues of the body during use are critical
devices and therefore, are required to be sterile.
Sterilant: Omnicide ™ is a sterilant for flexible endoscopes when used or reused,
according to the Directions For Use, at or above its Minimum Effective Concentration
(MEC) as detemlined by the ProChek G Glutaraldehyde Concentration Indicator Test
Strip at 68° F (20° C) with an immersion time of ten hours for a use period not to
exceed 28 days.
Flexible Endoscopes when expected to come in contact without penetration of mucous
membranes are semi-critical devices and therefore may be high level disinfected.
High Level Disinfectant: Omnicide TM is a high level disinfectant for flexible
endoscopes when used or reused, according to the Directions for Use, at or above its
Minimum Effective Concentration (MEC) as determined by the ProChek G
Glutaraldehyde Concentration Indicator Test Strip at 68°F (20° C) with an immersion
time of 45 minutes according to the instructions for use· in Section E for a use period • . I· ~ ,
not to exceed 28 days. ; l\G('.-~i· ~·i:. v
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Gener'll Procedure for High Level Disinfection of Flexible Endoscopes
(This procedure is recommended in the absence of specific
directions from the device manufacturer)
Trained Personnel
• Personnel involved in the reprocessing of endoscopes should have the ability to read.
understand. and implement instructions from manufactures and regulatory agencies as they
relate to endoscopic disinfection.
• The person(s) to whom the job of reprocessing endoscope~ is given should have the
opportunity to become completely familiar with the mechanical aspects of the endoscopic
equipment.
• Training should include familiarization with OSHA regulations and in-house policies on
how to appropriately and safely handle liquid chemical germicides.
• Training should also include information on the safe handling. of im.1ruments thar'are
contaminated with body fluids after use. This should include familiarizmion with t': ~:!~r-! :":)
universal precautions.
Cleaning of flexible endoscopes
- ' .. . . . . ,"
• Cleaning at the Examination Room .: ' .. , ... ." ... . . "... i :.;' ,1.:' ~. -.:. ': .:t,,!
. j:" : .:.... .;: .... :.~ •• ::-.:-.. i:o::·g. ~~~. : ... t.;6((')/-,*
Reflux of body fluids from the patient may occur in any of the standard channels:~ eleanmg of- -4,
endoscopes and accessories should be performed promptly after removing the endoscope from
the patient to prevent drying of secretions.
1. Personnel should dpnne all personnel protective equipment.
2. Prepare an enzyme detergent (e.g_. Pro EZ or Pro EZ Plus) or one recommended by the
scope manufacturer.
Cottrell 5 lOCk) K932922 Response 6/29/95 Page 13
I
3. Gently wipe all debris from the insertion tube with a moistened gauze or the like.
4. Place the distal end of the flexible endoscope into the water and enzyme detergent
solution and aspirate through the biopsy/suction channel for 5-10 seconds or until the
solution is visibly clean. Alternate aspiration of the detergent solution and air several
times. Finish by suctioning air.
5. Flush or blowout air and water channels in accordance with the endoscope manufacturers
instructions.
6. Transport the endoscope to the reprocessing area.
Cleaning at the Reprocessing A~~'!
, , . Attach any necessary water-tight caps to the electrical portions of the umbilicus.
2. Before proceeding with any further cleaning steps, the flexible endoscope should be leak
tested. (Refer to manufacturers leakage test instructions). Follow the manufacturers
instructions if the instrument appears damaged.
3. fill a sink or basin with a freshly made enzyme (e.g., Pro EZ or Pro EZ Plus) detergent
solution.
4. Immerse the endoscope. All channels should be irrigated with copious amounts of
detergent and tap water to soften, moisten, and dilute the organic debris. All detachable
parts (e.g., hoods and suction valves) should be removed and soaked in the detergent
solution. The insertion tube should be washed with detergent solution and rinsed.
5. Use a small soft brush to scrub all detachable parts.
6. Usc a brush to clean under the suction valve, air/water valve and biopsy port openings. ' .... . ... - ~ ..... ~", •
. ... . -. .. ~ ". '-_ .... ~_.$
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Cottrell 5 JOCk) K932922 Response 6/29/95
7. Brush the entire suction/biopsy system including the body, the insertion tube, and the
umbilicus of the endoscope in accordance with the manufacturer's instructions.
8. Accessible channel(s) should be brushed to remove particulate matter, and the detergent
solution must be suctioned or pumped through all channels to lemove dislodged material.
Channel irrigators may be useful for this step. Fill all channels with detergent solution
and soak 2-5 minutes in accordance to the Pro EZ instructions.
Rinse after cleaning:
9. Rinse the endoscope and all detachable parts in clean water.
10. Rinse all channels well with water to remove debri3 and detergent.
11. Purge water from all channels and wipe dry the exterior of the endoscope with a soft
clean cloth to prevent dilution of the Omnicide™ disinfectant used in subsequent Sieps.
Mallual Disinfection
12. Activate the OIlUlicide™ Long Life activated dialdehyde by adding the entire content of
the Activator bottle which is attached to the OIl}nicide™ solution container. Recap the
container and shake well. On activation, the solution immediately changes color to blue,
thereby indicating the solution is ready. Use ProChek G Glutaraldehyde Concentration
Indicator Test Strips after activation to determine that the solution is above the Minimum
Effective Concentration (MEC) before use.
Test the activated Ornnicide TM solution usmg the ProChek G Glutaraldehyde
Concentration Indicator at 20'C, before each usc.
13. A ttach channel irrigators/adapters and cover the biopsy port - in -accorsl.!lnce· 'with')he .- '4 - ~ -.,--. .'. ;.
manufacturer's instructions.
14. Pour the activated Omnicide™ into an appropriate sized basin.
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15. Completely immerse the endoscope in the basin of Omnicide™. Note: in order to prevent
damage to the endoscope, DO NOT soak any other accessory equipment with the
endoscope.
16. Inject the Omnicide™ solution into all channels of the endoscope until it can be seen
exiting the opposite end of each channel. Assure that all channels are filled with
disinfectant and that no air pockets remain within the channels.
17. Cover the disinfectant soaking basin with a tight fitting lid to minimize chemical vapor
exposure.
18. Soak the endoscope for 45 minutes. Use a timer to ensure adequate soaking time.
19. Before completely removing the endoscope from the disinfectant, flush all channels with
air to remove disinfectant.
Rinse After Manual Disinfection
20. Rinse 1: Fill a basin with two gallons of water (preferably sterile water). Place the
endoscope into the basin and thoroughly rinse the exterior of the scope. Attach channel
irrigators/adapters to the endoscope and flush with 500 rn1 of water through the channel
irrigator. Empty basin.
21. Rinse 2: Fill a basin with two gallons of water (preferably sterile water). Place the
endoscope into the basin and thoroughly rinse the exterior of the scope and flush with 500
ml of water through the charmel irrigator.
22. Purge all channels with air.
23. Flush all channels with 70% alcohol until the alcohol can be seen exiting the opposite end
of each channel.
24. Purge all channels with air.
25. Remove all adapters and devices.
Cottrell 510(k) K932922 Response 6/29/95
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26. Dry the exterior of the endoscope with a soft clean cloth. Do not attach detachable pans
to the endoscope prior to storage. Storage of endoscopes with the removable parts
detached lowers the risk of trapping liquid inside the instrument and facilitates continued
drying of the channels and channel openings. To prevent the growth of waterborne
organisms, the endoscope and all detached parts should be thoroughly dried prior to
storage.
27. Hang the endoscope vertically with the distal tip hanging freely in a well vemilated, du>t
free cabinet.
References:
I. ASTM:F 1518-94, Standard for Cleaning and Disinfecticn of Flexible Fiberoptic and
Video Endoscopes Used in the Examination of the Hollow Visera, Currcnt edition
approved May 15, 1994, Published July 1994.
') Martin, M.A., MD, Reichelderfer, M., APIC guideline for infection prevention and control
in l1exible endoscopy, Association for Professionals in Infection Control and
Epidemiology, Inc., AJIC Am J Infect Control 1994: 22: 19-38.
3. Vesley, D. et. a!., Significant factors in the disinfection and ~terilization of flexible
endoscopes, AJIC, December 1992, pg. 292.
4. Axon, A.T.R, Bond, B., Bottrill, P.M., Cowen, A.E., Fleisher, D.E. and Tandon, RK.,
Endoscopic disinfection, Working Party Reports, Blackwell Scientific Publications, 1990,
46-50. -" '~"' ... _.
-.''''-.. , ;
.'
".-. 2 - . I • . --
Cottrell 510(k) K932922 Response 6/29/95 Page 17
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OMNICIDETM LONG LIFE ACTIVATED DlALDEHYDE SOLUTION
PACKAGE INSERT
ULTRASOUND TRANSDUCER REPROCESSING
(Endocavity, Endovaginal, Enderectal, Transesophageal, ctc)
DRAFT LABELING
(Refer to the device manufacturer's instruction for specific procedures)
A. INTENDED USE/INSTRUCTIONS FOR USE
Omnicide™ activated dialdehyde solution is a liquid chemical sterilant, high level
disinfectant and intermediate levei disinfectant for ultrasound transducers when used
according to the Instructions For Use.
1. Germicide Level of Activity: Omnicide™ can be used at the followii.3 levels of
activity:
Sterilant: Omnicide ™ is a sterilant for ultrasound transducers when used or
reused «ccording to the Dirc(;tions For Use, at or above ilS Minimum Effective
Concentration (MEC) as detennined by the ProChek G Glutaraldehyde
Concentration Indicator Test Strip at 68° F(20° C) with an immersion time of ten
hours for a u~e period not (0 exceed 28 days.
High Lcvel Disinfcdant.: Onlllicide™ is a high level disinfectant for ultrasound
transducers when used or reused, according to the Directions for Use, at or above
its Minimum Effective Concentration (MEC) a!) determined by Prochek G
Glu!araldehyde Concentration Test Strip at 68°F(20°C) with an immersion time
of 45 minutes according to the instmctions for use in Section E for a use period
not to exceed 28 days.
'~f 0:-, .. ,', .
Cottrell 51O(k) K932922 Response 6/29/95 Page 18
. .. ,
/ . ,
Intermediate Level Disillff!ctallt: Omnicide™ is an intermediate level disinfec
tant when used or reused, according to the Directions for Use, at or above its
Minimum Effective Concentration (MEC) as determined by the Prochek G
Glutaraldehyde Concentration Indicator Strip at 68°F(20°C) with an immersion
time of 10 minutes according to the instmctions for use in Section E for a use
period not to exceed 28 days.
-... --~- ..
Cottrell 510(k) K932922 Response 6/29/95 Page 19
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Gcnc,"al Procedurc for High Level Disinfcction
of Ultrasound Transducers
(Endocavity, Endovaginal, Endorectal, Transesophageal, etc.)
(Refer to the device manufacturer's instruction for specific procedures)
Trained Personnel
• Personnel involved in the reprocessing of Ultrasound transducers should have the ability
to read, understand, and implement il.lstructions from manufactures and regulawry
agencies as they relate to transducer di5.';}fp-ction.
• The person(s) to whom the Job of rl!processing Ultrasound transducers is given should
havc the opportunity to become compleiely familiar with the mechanical aspects of the
ultrasound equipment.
• Training should include familiarization with OSHA regulations and in-house policies on
how to appropriately and safely handle liquid chemical germicides.
• Training should also include information on the safe handling of instruments that are
contaminated with body fluids aftcr use. This should include familiarization with
universal prccant ions.
Cleaning of Transducers . , , .
Cleaning of transducers and accessories should be performed promptly after patient use1~~ni~ent drying of secretions.
1. Personnel should donne all personnel protective equipment.
2. Prepare an enzyme'detergent (e.g., Pro EZ or Pro EZ Plus) or one reconunended by the
transducer manufacturer.
3. Gently wipe all debris from transducer surfaces with a moistened gauze or the like.
Cottrell 51O(k) K932922 Response 6/29{95 Page 20
6
4. Immerse the distal end of the transducer into the water and enzyme detergent solution for
2-5 mIllutes or as recommended by the device manufacturer.
NOTE: Refer to manufacturers instmctions for recommended immersion depth.
5. Rinse all surfaces with water and dry by wiping with a soft clean cloth.
Manual Disinfection
Caution: Omnicide™ may discolor the exterior of some transducers, however,
the acoustic or scanning performance is not impaired. Check with the
device manufactu rers for specific recommendations tefore proceeding.
6. Activate the Omnicide™ Long Life activated dialdehyde by adding the entire content of
the Activator bottIc which is attached to the Omnicide ™ solution container. Recap tne
container and shake well. On activation, the solution immediately changes color te blue,
thereby indicating the solution is ready. Use ProChek G Glutaraldehyde Concentration
Indicator Test Strips after activation to detelmine that the solution is above the Minimum
Effective Concentration (MEC) before use.
Test the activated Omnicide ™ solution uSlIlg the ProChek G Glmaraldehyde
Concentration Indicator at 20'C, before each use.
7. Pour the activated Omnkide™ into an appropriate sized basin.
8. Immerse the distal end of the transducer into the Omnicide™ solution. Note: Refer to
manufacturers instructions for recommended immersion depth.
9. Cover the disinfectant soaking basin to minimize chemical vapor exposure.
10. Soak the transducer for 45 minutes. Use a f ;mer to ensure adequate soaking time. ',.
.: :
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Rinse After Manual Disinfection
11. ginse 1: Fill a basin with a minimum of 1 gallon of water (preferably sterile water).
Place the transducer into the water to the recommended depth and allow to soak for 5
minutes. Remove the transducer.
12. Rinse 2: Holding the transducer over the basin, flush with fresh water (preferably sterile
water) for one minute.
13. Dry the transducer by wiping with a soft (preferably sterile) cloth.
Storage
Refer to manufacturer's recommendation.
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