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BD BBL ™ Thioglycollate Medium, Enriched with Vitamin K1 and Hemin

L007509 • Rev. 16 • March 2019QUALITY CONTROL PROCEDURES (Optional)

I INTRODUCTIONBD BBL™ Thioglycollate Medium, Enriched with Vitamin K1 and Hemin is a general-purpose medium for the cultivation of fastidious and nonfastidious microorganisms.

II PERFORMANCE TEST PROCEDURE1. Reduce tubes of the medium by boiling* with caps loosened. After boiling, tighten caps immediately and allow tubes to cool to

room temperature. *NOTE: Use of a microwave oven is not recommended.2. Preparation of inocula Use a 48- to 72-h culture of BD BBL Enriched Thioglycollate Medium, BD BBL Chopped Meat Medium, or colonies from a

BD BBL CDC Anaerobe 5% Sheep Blood Agar plate which have been transferred to a pre-reduced tube of Enriched Thioglycollate Medium, and adjust to a turbidity comparable to a 0.5 McFarland standard.

3. Using a sterile 0.01 mL calibrated loop, inoculate tubes from the standardized inoculum for each organism.4. Incubate tubes at 35 ± 2 °C in an aerobic atmosphere with tightened caps.5. Examine tubes after 18–24 and 42–48 h for growth.6. Expected Results

CLSI Organisms ATCC® Recovery*Peptostreptococcus anaerobius 27337 Growth*Bacteroides vulgatus 8482 Growth*Clostridium perfringens 13124 GrowthAdditional OrganismsClostridium novyi A 7659 Growth*Recommended organism strain for User Quality Control.

III ADDITIONAL QUALITY CONTROL1. Examine tubes as described under “Product Deterioration.”2. Visually examine representative tubes to assure that any existing physical defects will not interfere with use.3. DeterminethepHpotentiometricallyatroomtemperatureforadherencetothespecificationof7.0±0.2.4. Incubate uninoculated representative tubes at 20–25 °C and 30–35 °C and examine after 7 days for microbial contamination.

PRODUCT INFORMATIONIV INTENDED USE

BD BBL Thioglycollate Medium, Enriched with Vitamin K1 and Hemin is a general-purpose medium used in qualitative procedures or the cultivation of fastidious as well as nonfastidious microorganisms, including aerobic and anaerobic bacteria, from a variety of clinical and nonclinical materials.

V SUMMARY AND EXPLANATIONEnriched Thioglycollate Medium is BD BBL Thioglycollate Medium without Indicator-135C supplemented with vitamin K1 and hemin.1-3 The enriched broth medium is recommended for use in the isolation and cultivation of fastidious or slow growing, obligately anaerobic microorganisms present in clinical materials.4,5 It is also recommended for the isolation and cultivation of a wide variety of aerobic and facultatively anaerobic microorganisms. The medium is prepared with an anaerobic head space and is provided in screw-capped tubes in accordance with CDC recommendations.4 Vitamin K1 and hemin have been shown to be required by certain anaerobes for growth.6,7

The isolation of microorganisms from clinical materials frequently requires the use of enriched broth media in addition to the selective, differential and nonselective plated media normally used for primary isolation. The use of liquid “back up” media reduces the possibility of completely missing an etiological agent that is present in low numbers, slow growing on plated media, susceptible to selective agents, orsensitivetounfavorableincubationconditions;i.e.,insufficientanaerobiosisforoptimalgrowthofobligateanaerobes.

VI PRINCIPLES OF THE PROCEDURESodium thioglycollate, a reducing agent, maintains a low oxygen tension in the medium. Vitamin K1 is a growth requirement for some strains of Prevotella melaninogenica6 and is reported to enhance the growth of some strains of Bacteroides species and gram-positive nonsporeformers.8 Hemin is the source of the X factor which stimulates the growth of many microorganisms.

VII REAGENTSBD BBL Thioglycollate Medium, Enriched with Vitamin K1 and Hemin ApproximateFormula*PerLiterPurifiedWaterPancreatic Digest of Casein .................................................17.0 g Agar .................................................................................. 0.7 gPapaic Digest of Soybean Meal .............................................3.0 g L-Cystine .......................................................................... 0.25 gDextrose .................................................................................6.0g SodiumSulfite .................................................................. 0.1 gSodium Chloride .....................................................................2.5 g Hemin ............................................................................... 0.005 gSodium Thioglycollate ............................................................0.5 g Vitamin K1 ......................................................................... 0.001 g*Adjusted and/or supplemented as required to meet performance criteria.

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Warnings and Precautions: For in vitro Diagnostic Use.Caution should be exercised in reporting direct Gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium.Tubes with tight caps should be opened carefully to avoid injury due to breakage of glass.Pathogenicmicroorganisms,includinghepatitisvirusesandHumanImmunodeficiencyVirus,maybepresentinclinicalspecimens.“Standard Precautions”9-12 and institutional guidelines should be followed in handling all items contaminated with blood and other bodyfluids.Afteruse,preparedtubes,specimencontainersandothercontaminatedmaterialsmustbesterilizedbyautoclavingbefore discarding.Storage Instructions: On receipt, store tubes in the dark at 2–8 °C. Avoid freezing and overheating. Do not open until ready to use. Minimize exposure to light. Tubed media stored as labeled until just prior to use may be inoculated up to the expiration date and incubated for the recommended incubation times. Allow the medium to warm to room temperature before inoculation.Product Deterioration: Do not use tubes if they show evidence of microbial contamination, discoloration, drying or other signs of deterioration.

VIII SPECIMEN COLLECTION AND HANDLINGSpecimens suitable for culture may be handled using various techniques. For detailed information, consult appropriate texts.13,14 Specimens should be obtained before antimicrobial agents have been administered. Provision must be made for prompt delivery to the laboratory.

IX PROCEDUREMaterial Provided: BD BBL Thioglycollate Medium, Enriched with Vitamin K1 and HeminMaterials Required But Not Provided: Ancillary culture media, reagents, quality control organisms and laboratory equipment as required.Test Procedure: Observe aseptic techniques.Liquid media for anaerobic incubation should be reduced prior to inoculation by placing the tubes, with caps loosened, under anaerobicconditionfor18–24hpriortouse.AnefficientandeasywaytoobtainsuitableanaerobicconditionsisthroughtheuseoftheBD GasPak™ EZ anaerobic system. Alternatively, liquid media may be reduced immediately prior to use by boiling*, with caps loosened, and cooling, with tightened caps, to room temperature before inoculation.Inoculatethespecimenintothemediaofchoiceassoonasitarrivesinthelaboratory.Withliquidspecimens,tubedmediashouldbeinoculated with one or two drops of the specimen. Tissue specimens should be minced and ground in sterile, reduced broth such as Enriched Thioglycollate Medium for the cultivation of microorganisms. Inoculation is then performed as for liquid specimens. Swab specimens may be inserted into the broth after inoculation of plated media. Alternatively, the swab may be “scrubbed” in a small volume of sterile, reduced broth such as Enriched Thioglycollate Medium and the broth used to inoculate media as performed with liquid specimens.Specimens known or suspected to contain obligate anaerobes should be inoculated near the bottom of the tube. Incubate tubes with tight caps aerobically at 35 ± 2 °C or other appropriate temperature.Broth cultures should be held at least 1 week before discarding as negative.15

*NOTE: Use of a microwave oven is not recommended.User Quality Control: See “Quality Control Procedures.”EachlotofmediahasbeentestedusingappropriatequalitycontrolorganismsandthistestingmeetsproductspecificationsandCLSIstandards, where relevant. As always, QC testing should be performed in accordance with applicable local, state, federal or country regulations, accreditation requirements, and/or your laboratory’s standard quality control procedures..AsingleelectrodeofsufficientlysmallsizetofitintothetubesshouldbeusedtodeterminethepHpotentiometricallyoftubedmedia.The tip of the electrode should be placed below the surface of broth media.

X RESULTSGrowth in broth tubes, such as BD BBL Enriched Thioglycollate Medium, is demonstrated by the appearance of turbidity when compared to an uninoculated control.If growth is detected, cultures should be examined by Gram staining and subcultured onto selective and nonselective plated media. If anaerobes are suspected, subcultures should also be made to appropriate anaerobic plated media.

XI LIMITATIONS OF THE PROCEDUREAnaerobes can be overgrown by more rapidly growing facultative organisms. Examine and Gram stain broth if plating medium reveals no growth. Never rely on broth cultures exclusively for isolation of anaerobes. Some anaerobes may be inhibited by metabolic products or acids produced from more rapidly growing facultative anaerobes.15

Foridentification,organismsmustbeinpureculture.Morphological,biochemical,and/orserologicaltestsshouldbeperformedforfinalidentification.Consultappropriatetextsfordetailedinformationandrecommendedprocedures.13,14,16

Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media. Other sources of dead organisms visible upon Gram staining include staining reagents, immersion oil, glass slides and the specimens used for inoculation. If there is uncertainty about the validity of the Gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.

XII PERFORMANCE CHARACTERISTICSPrior to release, all lots of BD BBL Thioglycollate Medium, Enriched with Vitamin K1 and Hemin are tested for performance characteristics. Before inoculation, representative samples of the lot are reduced by boiling in a water bath for a minimum of 10 minutes and cooled. Using a 0.01 mL calibrated loop, tubes are inoculated with cultures that have been adjusted to a 0.5 McFarland turbidity standard. The inocula for Clostridium perfringens (ATCC 13124) and Peptostreptococcus anaerobius (ATCC 27337) are prepared from colonies grown on BD BBL CDC Anaerobe 5% Sheep Blood Agar plates and adjusted to the correct inoculum concentration in pre-reduced Thioglycollate Medium, Enriched. The inoculum for Bacteroides vulgatus (ATCC 8482) is taken from Thioglycollate Medium, Enriched and the inoculum for C. novyi A (ATCC 7659) is taken from Chopped Meat Glucose Broth, PR II. Tubes are inoculated below the surface of the broths as deeply into the medium as possible. The caps are tightened immediately after inoculation and the tubes are incubated aerobically at 35 ± 2 °C. Tubes are read for the amount of growth after 18–24 h and 42–48 h. All organisms show trace to heavy growth after 48 h.

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XIII AVAILABILITYCat. No. Description221742 BD BBL™ Thioglycollate Medium, Enriched with Vitamin K1, and Hemin, 5 mL221787 BD BBL™ Thioglycollate Medium, Enriched with Vitamin K1, and Hemin, 8 mL221788 BD BBL™ Thioglycollate Medium, Enriched with Vitamin K1, and Hemin, 8 mL297292 BD BBL™ Thioglycollate Medium, Enriched with Vitamin K1, and Hemin, 10 mL

XIV REFERENCES1. Brewer, J.H. 1940. A clear liquid medium for the “aerobic” cultivation of anaerobes. J. Bacteriol. 39:10.2. Vera, H.D. 1944. Comparative study of materials suitable for the cultivation of clostridia. J. Bacteriol. 47:59–65.3. Dowell, V.R., Jr., and T.M. Hawkins. 1987. Laboratory methods in anaerobic bacteriology. CDC laboratory manual. HHS Publication No. (CDC) 7–8272.

Centers for Disease Control, Atlanta.4. Dowell,V.R.,Jr.,G.L.Lombard,F.S.Thompson,andA.Y.Armfield.1977.Mediaforisolation,characterization,andidentificationofobligatelyanaerobic

bacteria. CDC laboratory manual. Center for Disease Control, Atlanta.5. Forbes, B.A., and P.A. Granato. 1995. Processing specimens for bacteria, p. 265–281. In P.R. Murray, E.J. Baron, M.A. Pfaller, F.C. Tenover, and

R.H.Yolken(ed.),Manualofclinicalmicrobiology,6thed.AmericanSocietyforMicrobiology,Washington,D.C.6. Gibbons, R.J. and J.B. MacDonald. 1960. Hemin and vitamin K compounds as required factors for the cultivation of certain strains of

Bacteroides melaninogenicus. J. Bacteriol. 80:164–170.7. Wilkins,T.D.,S.L.Chalgren,F.Jimeniz-Ulate,C.R.Drake,Jr.,andJ.L.Johnson.1976.InhibitionofBacteroides fragilis on blood agar plates and

reversal of inhibition by added hemin. J. Clin. Microbiol. 3:359–363.8. Finegold, S.M., V.L. Sutter, H.R. Attebery, and J.E. Rosenblatt. 1974. Isolation of anaerobic bacteria, p. 365–375. In E.H. Lennette, G.H. Spaulding,

andJ.P.Truant(ed.),Manualofclinicalmicrobiology,2nded.AmericanSocietyforMicrobiology,Washington,D.C.9. Clinical and Laboratory Standards Institute. 2005. Approved Guideline M29-A3. Protection of laboratory workers from occupationally acquired

infections,3rded.CLSI,Wayne,Pa.10. Garner, J.S. 1996. Hospital Infection Control Practices Advisory Committee, U.S. Department of Health and Human Services, Centers for Disease

Control and Prevention. Guideline for isolation precautions in hospitals. Infect. Control Hospital Epidemiol. 17:53–80.11. U.S. Department of Health and Human Services. 2007. Biosafety in microbiological and biomedical laboratories, HHS Publication (CDC), 5th ed.

U.S.GovernmentPrintingOffice,Washington,D.C.12. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to

exposuretobiologicalagentsatwork(seventhindividualdirectivewithinthemeaningofArticle16(1)ofDirective89/391/EEC).OfficialJournalL262,17/10/2000, p. 0021–0045.

13. Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry and M.A. Pfaller (ed.). 2007. Manual of clinical microbiology, 9th ed. American Society for Microbiology,Washington,D.C.

14. Forbes,B.A.,D.F.Sahm,andA.S.Weissfeld.2007.Bailey&Scott’sdiagnosticmicrobiology,12thed.Mosby,Inc.,St.Louis.15. Reischelderfer, C., and J.I. Mangels. 1994. Culture media for anaerobes, p. 2.3.1–2.3.8. In H.D. Isenberg (ed.), Clinical microbiology procedures

handbook,vol.1.AmericanSocietyforMicrobiology,Washington,D.C.16. Holt,J.G.,N.R.Krieg,P.H.A.Sneath,J.T.Staley,andS.T.Williams(ed.).1994.Bergey’sManualofdeterminativebacteriology,9thed.

Williams&Wilkins,Baltimore.

Technical Information: In the United States contact BD Technical Service and Support at 1.800.638.8663 or www.bd.com.

Change HistoryRevision Date Change Summary

(16) 2019-03 Deleted Porphyromonas levii organism.Added CE mark.

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US Customers only: For symbol glossary, refer to www.bd.com/symbols-glossary

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Serialnumber/Сериенномер/Sériovéčíslo/Serienummer/Seriennummer/Σειριακόςαριθμός/Nºdeserie/Seerianumber/Numérodesérie/Serijskibroj/Sorozatszám/Numerodiserie/Топтамалықнөмірі/일련 번호 /Serijosnumeris/Sērijasnumurs/Serienummer/Numerseryjny/Númerodesérie/Numărdeserie/Серийныйномер/Serinumarası/Номерсерії/序列号

ForIVDPerformanceevaluationonly/СамозаоценкакачествотонаработанаIVD/PouzeprovyhodnocenívýkonuIVD/KuntilevalueringafIVDydelse/NurfürIVD-Leistungsbewertungszwecke/MόνογιααξιολόγησηαπόδοσηςIVD/Sóloparalaevaluacióndelrendimientoendiagnósticoinvitro/AinultIVDseadmehindamiseks/Réservéàl’évaluationdesperformancesIVD/SamouznanstvenesvrhezaInVitroDijagnostiku/Kizárólaginvitrodiagnosztikához/SolopervalutazionedelleprestazioniIVD/Жасандыжағдайда«пробиркаішінде»,диагностикадатекжұмыстыбағалауүшін/IVD 성능 평가에 대해서만

사용 /TikIVDprietaisųveikimocharakteristikomstikrinti/VienīgiIVDdarbībasnovērtēšanai/Uitsluitendvoordoeltreffendheidsonderzoek/KunforevalueringavIVD-ytelse/TylkodoocenywydajnościIVD/UsoexclusivoparaavaliaçãodeIVD/NumaipentruevaluareaperformanţeiIVD/Толькодляоценкикачествадиагностикиinvitro/Určenéibanadiagnostikuinvitro/Samozaprocenuučinkauinvitrodijagnostici/Endastförutvärderingavdiagnostiskanvändninginvitro/YalnızcaIVDPerformansdeğerlendirmesiiçin/Тількидляоцінюванняякостідіагностикиinvitro/仅限 IVD 性能评估

For US: “For Investigational Use Only”

Lowerlimitoftemperature/Доленлимитнатемпературата/Dolníhraniceteploty/Nedretemperaturgrænse/Temperaturuntergrenze/Κατώτεροόριοθερμοκρασίας/Límiteinferiordetemperatura/Aluminetemperatuuripiir/Limiteinférieuredetempérature/Najnižadozvoljenatemperatura/Alsóhőmérsékletihatár/Limiteinferioreditemperatura/Температураныңтөменгіруқсатшегі/하한 온도 /Žemiausialaikymotemperatūra/Temperatūraszemākārobeža/Laagstetemperatuurlimiet/Nedretemperaturgrense/Dolnagranicatemperatury/Limiteminimodetemperatura/Limităminimădetemperatură/Нижнийпределтемпературы/Spodnáhranicateploty/Donjagranicatemperature/Nedretemperaturgräns/Sıcaklıkaltsınırı/Мінімальнатемпература/温度下限

Control/Контролно/Kontrola/Kontrol/Kontrolle/Μάρτυρας/Kontroll/Contrôle/Controllo/Бақылау/ 컨트롤 /Kontrolė/Kontrole/Controle/Controlo/Контроль/kontroll/Контроль/对照

Positivecontrol/Положителенконтрол/Pozitivníkontrola/Positivkontrol/PositiveKontrolle/Θετικόςμάρτυρας/Controlpositivo/Positiivnekontroll/Contrôlepositif/Pozitivnakontrola/Pozitívkontroll/Controllopositivo/Оңбақылау/ 양성 컨트롤 /Teigiamakontrolė/Pozitīvākontrole/Positievecontrole/Kontroladodatnia/Controlopositivo/Controlpozitiv/Положительныйконтроль/Pozitifkontrol/Позитивнийконтроль/阳性对照试剂

Negativecontrol/Отрицателенконтрол/Negativníkontrola/Negativkontrol/NegativeKontrolle/Αρνητικόςμάρτυρας/Controlnegativo/Negatiivnekontroll/Contrôlenégatif/Negativnakontrola/Negatívkontroll/Controllonegativo/Негативтікбақылау/ 음성 컨트롤 /Neigiamakontrolė/Negatīvākontrole/Negatievecontrole/Kontrolaujemna/Controlonegativo/Controlnegativ/Отрицательныйконтроль/Negatifkontrol/Негативнийконтроль/阴性对照试剂

L007509 5

Methodofsterilization:ethyleneoxide/Методнастерилизация:етиленовоксид/Způsobsterilizace:etylenoxid/Steriliseringsmetode:ethylenoxid/Sterilisationsmethode:Ethylenoxid/Μέθοδοςαποστείρωσης:αιθυλενοξείδιο/Métododeesterilización:óxidodeetileno/Steriliseerimismeetod:etüleenoksiid/Méthodedestérilisation:oxyded’éthylène/Metodasterilizacije:etilenoksid/Sterilizálásmódszere:etilén-oxid/Metododisterilizzazione:ossidodietilene/Стерилизацияәдісі–этилентотығы/ 소독 방법: 에틸렌옥사이드 /Sterilizavimobūdas:etilenooksidas/Sterilizēšanasmetode:etilēnoksīds/Gesteriliseerdmetbehulpvanethyleenoxide/Steriliseringsmetode:etylenoksid/Metodasterylizacji:tleneketylu/Métododeesterilização:óxidodeetileno/Metodădesterilizare:oxiddeetilenă/Методстерилизации:этиленоксид/Metódasterilizácie:etylénoxid/Metodasterilizacije:etilenoksid/Steriliseringsmetod:etenoxid/Sterilizasyonyöntemi:etilenoksit/Методстерилізації:етиленоксидом/灭菌方法：环氧乙烷

Methodofsterilization:irradiation/Методнастерилизация:ирадиация/Způsobsterilizace:záření/Steriliseringsmetode:bestråling/Sterilisationsmethode:Bestrahlung/Μέθοδοςαποστείρωσης:ακτινοβολία/Métododeesterilización:irradiación/Steriliseerimismeetod:kiirgus/Méthodedestérilisation:irradiation/Metodasterilizacije:zračenje/Sterilizálásmódszere:besugárzás/Metododisterilizzazione:irradiazione/Стерилизацияәдісі–сәулетүсіру/ 소독 방법: 방사 /Sterilizavimobūdas:radiacija/Sterilizēšanasmetode:apstarošana/Gesteriliseerdmetbehulpvanbestraling/Steriliseringsmetode:bestråling/Metodasterylizacji:napromienianie/Métododeesterilização:irradiação/Metodădesterilizare:iradiere/Методстерилизации:облучение/Metódasterilizácie:ožiarenie/Metodasterilizacije:ozračavanje/Steriliseringsmetod:strålning/Sterilizasyonyöntemi:irradyasyon/Методстерилізації:опроміненням/灭菌方法：辐射

BiologicalRisks/Биологичнирискове/Biologickárizika/Biologiskfare/Biogefährdung/Βιολογικοίκίνδυνοι/Riesgosbiológicos/Bioloogilisedriskid/Risquesbiologiques/Biološkirizik/Biológiailagveszélyes/Rischiobiologico/Биологиялықтәуекелдер/ 생물학적 위험 /Biologinispavojus/Bioloģiskieriski/Biologischrisico/Biologiskrisiko/Zagrożeniabiologiczne/Perigobiológico/Riscuribiologice/Биологическаяопасность/Biologickériziko/Biološkirizici/Biologiskrisk/BiyolojikRiskler/Біологічнанебезпека/生物学风险

Caution,consultaccompanyingdocuments/Внимание,направетесправкавпридружаващитедокументи/Pozor!Prostudujtesipřiloženoudokumentaci!/Forsigtig,seledsagendedokumenter/Achtung,Begleitdokumentebeachten/Προσοχή,συμβουλευτείτετασυνοδευτικάέγγραφα/Precaución,consultarladocumentaciónadjunta/Ettevaatust!Lugedakaasnevatdokumentatsiooni/Attention,consulterlesdocumentsjoints/Upozorenje,koristipratečudokumentaciju/Figyelem!Olvassaelamellékelttájékoztatót/Attenzione:consultareladocumentazioneallegata/Абайлаңыз,тиістіқұжаттарментанысыңыз/ 주의, 동봉된 설명서 참조 /Dėmesio,žiūrėkitepridedamusdokumentus/Piesardzība,skatītpavaddokumentus/Voorzichtig,raadpleegbijgevoegdedocumenten/Forsiktig,sevedlagtdokumentasjon/Należyzapoznaćsięzdołączonymidokumentami/Cuidado,consulteadocumentaçãofornecida/Atenţie,consultaţidocumenteleînsoţitoare/Внимание:см.прилагаемуюдокументацию/Výstraha,pozrisprievodnédokumenty/Pažnja!Pogledajtepriloženadokumenta/Obs!Semedföljandedokumentation/Dikkat,birlikteverilenbelgelerebaşvurun/Увага:див.супутнюдокументацію/小心，请参阅附带文档。

Upperlimitoftemperature/Горенлимитнатемпературата/Horníhraniceteploty/Øvretemperaturgrænse/Temperaturobergrenze/Ανώτεροόριοθερμοκρασίας/Límitesuperiordetemperatura/Üleminetemperatuuripiir/Limitesupérieuredetempérature/Gornjadozvoljenatemperatura/Felsőhőmérsékletihatár/Limitesuperioreditemperatura/Температураныңруқсатетілгенжоғарғышегі/상한 온도 / Aukščiausialaikymotemperatūra/Augšējātemperatūrasrobeža/Hoogstetemperatuurlimiet/Øvretemperaturgrense/Górnagranicatemperatury/Limitemáximodetemperatura/Limitămaximădetemperatură/Верхнийпределтемпературы/Hornáhranicateploty/Gornjagranicatemperature/Övretemperaturgräns/Sıcaklıküstsınırı/Максимальнатемпература/温度上限

Keepdry/Пазетесухо/Skladujtevsuchémprostředí/Opbevarestørt/Trocklagern/Φυλάξτετοστεγνό/Mantenerseco/Hoidakuivas/Conserverausec/Držatinasuhom/Szárazhelyentartandó/Tenereall’asciutto/Құрғақкүйіндеұста/ 건조 상태 유지 /Laikykitesausai/Uzglabātsausu/Drooghouden/Holdestørt/Przechowywaćwstaniesuchym/Manterseco/Aseferideumezeală/Недопускатьпопаданиявлаги/Uchovávajtevsuchu/Držitenasuvommestu/Förvarastorrt/Kurubirşekildemuhafazaedin/Берегтивідвологи/请保持干燥

Collectiontime/Временасъбиране/Časodběru/Opsamlingstidspunkt/Entnahmeuhrzeit/Ώρασυλλογής/Horaderecogida/Kogumisaeg/Heuredeprélèvement/Satiprikupljanja/Mintavételidőpontja/Oradiraccolta/Жинаууақыты/수집 시간 /Paėmimolaikas/Savākšanaslaiks/Verzameltijd/Tidprøvetaking/Godzinapobrania/Horadecolheita/Oracolectării/Времясбора/Dobaodberu/Vremeprikupljanja/Uppsamlingstid/Toplamazamanı/Часзабору/采集时间

Peel/Обелете/Otevřetezde/Åbn/Abziehen/Αποκολλήστε/Desprender/Koorida/Décoller/Otvoritiskini/Húzzale/Staccare/Ұстіңгіқабатыналыптаста/ 벗기기 /Plėštičia/Atlīmēt/Schillen/Trekkav/Oderwać/Destacar/Sedezlipeşte/Отклеить/Odtrhnite/Oljuštiti/Draisär/Ayırma/Відклеїти/撕下

Perforation/Перфорация/Perforace/Perforering/Διάτρηση/Perforación/Perforatsioon/Perforacija/Perforálás/Perforazione/Тесіктесу/ 절취선 /Perforacija/Perforācija/Perforatie/Perforacja/Perfuração/Perforare/Перфорация/Perforácia/Perforasyon/Перфорація/穿孔

Donotuseifpackagedamaged/Неизползвайте,акоопаковкатаеповредена/Nepoužívejte,je-liobalpoškozený/Måikkeanvendeshvisemballagenerbeskadiget/InhalbeschädigterPackungnichtverwenden/Μηχρησιμοποιείτεεάνησυσκευασίαέχειυποστείζημιά./Nousarsielpaqueteestádañado/Mittekasutada,kuipakendonkahjustatud/Nepasl’utilisersil’emballageestendommagé/Nekoristitiakojeoštećenopakiranje/Nehasználja,haacsomagolássérült/Nonusareselaconfezioneèdanneggiata/Егерпакетбұзылғанболса,пайдаланба/ 패키지가 손상된 경우 사용 금지 / Jei pakuotėpažeista,nenaudoti/Nelietot,jaiepakojumsbojāts/Nietgebruikenindiendeverpakkingbeschadigdis/Måikkebrukeshvispakkeerskadet/Nieużywać,jeśliopakowaniejestuszkodzone/Nãousarseaembalagemestiverdanificada/Anusefolosidacăpachetulestedeteriorat/Неиспользоватьприповрежденииупаковки/Nepoužívajte,akjeobalpoškodený/Nekoristiteakojepakovanjeoštećeno/Användejomförpackningenärskadad/Ambalajhasargörmüşsekullanmayın/Невикористовуватизапошкодженоїупаковки/如果包装破损，请勿使用

Keepawayfromheat/Пазетеоттоплина/Nevystavujtepřílišnémuteplu/Måikkeudsættesforvarme/VorWärmeschützen/Κρατήστετομακριάαπότηθερμότητα/Manteneralejadodefuentesdecalor/Hoidaeemalvalgusest/Protégerdelachaleur/Držatidaljeodizvoratopline/Óvjaamelegtől/Tenerelontanodalcalore/Салқынжердесақта/ 열을 피해야 함 /Laikytiatokiaunuošilumosšaltinių/Sargātnokarstuma/Beschermentegenwarmte/Måikkeutsettesforvarme/Przechowywaćzdalaodźródełciepła/Manteraoabrigodocalor/Aseferidecăldură/Ненагревать/Uchovávajtemimozdrojatepla/Držitedaljeodtoplote/Fårejutsättasförvärme/Isıdanuzaktutun/Берегтивіддіїтепла/请远离热源

Cut/Срежете/Odstřihněte/Klip/Schneiden/Κόψτε/Cortar/Lõigata/Découper/Reži/Vágjaki/Tagliare/Кесіңіз/ 잘라내기 /Kirpti/Nogriezt/Knippen/Kutt/Odciąć/Cortar/Decupaţi/Отрезать/Odstrihnite/Iseći/Klipp/Kesme/Розрізати/剪下

Collectiondate/Датанасъбиране/Datumodběru/Opsamlingsdato/Entnahmedatum/Ημερομηνίασυλλογής/Fechaderecogida/Kogumiskuupäev/Datedeprélèvement/Daniprikupljanja/Mintavételdátuma/Datadiraccolta/Жинағантізбекүні/ 수집 날짜 /Paėmimodata/Savākšanasdatums/Verzameldatum/Datoprøvetaking/Datapobrania/Datadecolheita/Datacolectării/Датасбора/Dátumodberu/Datumprikupljanja/Uppsamlingsdatum/Toplamatarihi/Датазабору/采集日期

µL/test/µL/тест/µL/Test/µL/εξέταση/µL/prueba/µL/teszt/ µL/테스트 /мкл/тест/µL/tyrimas/µL/pārbaude/µL/teste/мкл/аналіз/µL/检测

Keepawayfromlight/Пазетеотсветлина/Nevystavujtesvětlu/Måikkeudsættesforlys/VorLichtschützen/Κρατήστετομακριάαπότοφως/Manteneralejadodelaluz/Hoidaeemalvalgusest/Conserveràl’abridelalumière/Držatidaljeodsvjetla/Fénynemérheti/Tenerealriparodallaluce/Қараңғыланғанжердеұста/ 빛을 피해야 함 /Laikytiatokiaunuošilumosšaltinių/Sargātnogaismas/Nietblootstellenaanzonlicht/Måikkeutsettesforlys/Przechowywaćzdalaodźródełświatła/Manteraoabrigodaluz/Feriţidelumină/Хранитьвтемноте/Uchovávajtemimodosahusvetla/Držitedaljeodsvetlosti/Fårejutsättasförljus/Işıktanuzaktutun/Берегтивіддіїсвітла/请远离光线

Hydrogengasgenerated/Образуваневодородгаз/Možnostúnikuplynnéhovodíku/Frembringerhydrogengas/Wasserstoffgaserzeugt/Δημιουργίααερίουυδρογόνου/Produccióndegasdehidrógeno/Vesinikgaasitekitatud/Produitdel’hydrogènegazeux/Sadržihydrogenvodik /Hidrogéngáztfejleszt/Produzionedigasidrogeno/Газтектессутегіпайдаболды/ 수소 가스 생성됨/Išskiriavandeniliodujas/Rodasūdeņradis/Waterstofgasgegenereerd/Hydrogengassgenerert/Powodujepowstawaniewodoru/Produçãodegásdehidrogénio/Generaregazdehidrogen/Выделениеводорода/Vyrobenépoužitímvodíka/Oslobađasevodonik/Genereradvätgas/Açığaçıkanhidrojengazı/Реакціязвиділеннямводню/会产生氢气

PatientIDnumber/ИДномернапациента/IDpacienta/PatientensID-nummer/Patienten-ID/Αριθμόςαναγνώρισηςασθενούς/NúmerodeIDdelpaciente/PatsiendiID/Nod’identificationdupatient/Identifikacijskibrojpacijenta/Betegazonosítószáma/NumeroIDpaziente/Пациенттіңидентификациялықнөмірі/ 환자 ID 번호 / Paciento identifikavimo numeris / Pacienta ID numurs / Identificatienummer vandepatiënt/PasientensID-nummer/NumerIDpacjenta/NúmerodaIDdodoente/NumărIDpacient/Идентификационныйномерпациента/Identifikačnéčíslopacienta/IDbrojpacijenta/Patientnummer/Hastakimliknumarası/Ідентифікаторпацієнта/患者标识号

Fragile,HandlewithCare/Чупливо,Работетеснеобходимотовнимание./Křehké.Přimanipulacipostupujteopatrně./Forsigtig,kangåistykker./Zerbrechlich,vorsichtighandhaben./Εύθραυστο.Χειριστείτετομεπροσοχή./Frágil.Manipularconcuidado./Õrn,käsitsegeettevaatlikult./Fragile.Manipuleravecprécaution./Lomljivo,rukujtepažljivo./Törékeny!Óvatosankezelendő./Fragile,maneggiareconcura./Сынғыш,абайлаппайдаланыңыз./조심 깨지기 쉬운 처리/Trapu,elkitėsatsargiai./Trausls;rīkotiesuzmanīgi/Breekbaar,voorzichtigbehandelen./Ømtålig,håndterforsiktig./Kruchazawartość,przenosićostrożnie./Frágil,ManuseiecomCuidado./Fragil,manipulaţicuatenţie./Хрупкое!Обращатьсясосторожностью./Krehké,vyžadujesaopatrnámanipulácia./Lomljivo-rukujtepažljivo./Bräckligt.Hanteraförsiktigt./KolayKırılır,DikkatliTaşıyın./Тендітна,звертатисязобережністю/易碎，小心轻放

This only applies to US: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.” / S’applique uniquement aux États-Unis: “Caution: Federal Law restricts this device to sale by orontheorderofalicensedpractitioner.”/ValesolopergliStatiUniti:“Caution:FederalLawrestrictsthisdevicetosalebyorontheorderofalicensedpractitioner.”/GiltnurfürdieUSA:“Caution:FederalLawrestrictsthisdevicetosalebyorontheorderofalicensedpractitioner.”/SóloseaplicaalosEE.UU.:“Caution:FederalLawrestrictsthisdevicetosalebyorontheorderofalicensedpractitioner.”

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