Drager Gp Gebrauchsanweisung Instrukeja obstugi 53 B36 NG nstructions for Use ail. PyroroncTe0 no skcnnyarauun 56 B39 Notice dutlisation Upute za uporabu i eo ay £42 tgp Instrucciones de uso py Nevodiio za uporabo B12 B45 Instrugdes de utlizacéo Navod na pousitie om 815 aaa Gm Istrzioni per tuso ey Nvod na pouziti B18 B61 Gebruksaanwjzing Pekosoncree sa pa6or fy 21 oO es4 Gam) Brugsanvisning Gl lestructiuni de utiizare 224 557 Fim Kayttoonjeot ae Haszndlat ctmutats B27 60 any Buksanvisning SGN Davies Xprions 830 E63 Wy Bruksanvisning Gp Kullanma talmatian 533 266 jy at 'be9 Not for sale in the US market Drager DrugTest® 5000 STK IVD Drager. Technology for Life”For your safety 1 For your safety 1.4 Strictly follow the Instructions for Use use of the Drager DrugTest® 5000 STK"? requis ful ‘orcanaing an etrt cbvervaion of thee nsructons fr Use. ‘The components of the Drager OrugTest $000 STK are intended for, the presoried use ony. 2 Description 24 Product overview “I “The Drier DragTet 5000 tes sytem ga quataive measurement Prooslas, f'pouses fom on the resencs of te tested Ebstanoes in he sample above or blow a kt vaio (co) and ‘hereto ony supeos 9 preiminery araial result o coin 8 Corsnmad andy reut 8 more spec aerate chomicaletod 'tocces, "Ie qreered-mabede are Gomis or LEMS = S00 Secton 3.3 *Contmaton of eau A th. rosie of the Drager Orugest $000 tee aytom requis pyotosuonal essnsmant wih reference fires cea sscesron Erte tos subjocs Ths I parca eppabe ors reimenry ative rel neo Talo 1 (4) ot pogo 2. Depending on he confguraton ofthe Origer Dugas! 5000 STK he Drlger Crypto S000 tet ayetem can be used to. conn the protsros oe olowing ue Drug (target analyte) “Amphetamine (amphetamine sufate) 2. test easste with niepreted sarrer 8 Sey cap win conte «+ Instucon or Use Measurement mode: fast (THO) Benzodiazepines (Diazepam) Cocaine (oosin) 3 6 14 Ketamine (iamine) eaci patos (morphine) Teahyérosannabina (49-THC) 5 | 23 Explanation of symbols sem [TR] Srey fotow the instructions or Use! 1 Caruidge a 2 Safely cap ta | Moruractrer 3 Samo inscatr TET | tre dagnoste eal rou 5 Housing wih test sip 6 Sampler older Ge | Baer Each packing unt contains Tamporatue limitation + Drager Drgtet 800 ST, each packed na sane ol pours, ‘Tevexact rmber i usiaied on the abel onthe pecking unt.” | | Expiry dato rey fl pouch onan 9 pouch wih Sesccnt ard a roger Drudos Oo SG rein YY | Content srcient for <> tsi G 244 _ Required materials that are not included (© Drager DrugTast 5000 Analyzer (order no. 83 19 900) for progessing and analyss of tre lost cassetes. 24.2 Additional recommended materials ‘© Drager DCD® 5000 (order no. B3 18 910) Drager Mobile Printer (order no. eg. 83 19 310) © Disposable gloves (0.9, latex or nite gloves) 22 — Intended use ‘The Drager DrugTest 5000 test system consisis of the Drager Dros 8000 Aatyzer and ne Drager DrugTes S000 STK. Tho test system is @ point of collecton test for the simultaneous, qualistive Getocton of up to 8 anatjes in human oral samples fot Giagnoste Purposes (e-wiro agnostics) or for forensic use. Depending onthe version, the Drdgor DrugTest 5000 STKis designed for the detection ‘of influence by amphetamine, benzodiazepine, Cocaine, Ketamine, methadone, methamphetamine, opiates and THC! ‘Cannabis, Designer amphetamines (e.2. MOMAtEestasy) are also ‘etocted by cross reactivities. The labal on the packaging provides ‘formation about’ the present. version of the Drager Drugtest 5000 STK and the ‘mt value {in ngimt) for the spect ‘substance, The meaning of the abbreviations cari be found in the ‘abi Anais, win temware 2:00 or Noher an, proces, Drdger Drug fest 5000 STK witn various evaluation times if this opfon Is ctvated in the Analyzer. The evaluation imo ony fluences the mit ‘of THC: a shor evaluation ime inereases the mt valve, 2 1ong ition tne reduces l Al oer anslytos are ovalusted ith the Imi value regardless ofthe meacurement mode. If the Drager DrugTest 5900 STK enables diferent evaluation tines, the label on the packaging also shows the limit value for THC Inthe various meacurerentm 1) Drager Dug Testis a registered wadorark of Drager. Measurement mode: sensitive (THC) 24 Test principle ‘The Drager DrugTest 5000 test system is basod onthe immunoassay principle of compettive inhibiton. Drugs contained in tre ‘sample Compete wih drugs on the test_ membrane for the cohesion ‘of Imiciopatcles coated witn antibodies. Sampling: ‘The ‘Drager DrugTest 5000 STK is designed for use with saliva Samples, which ae taken wih the integrated sampler. ‘Tho sample does not require special treatment. The sample is taken rectly by absorption into the sample, which is integrated nto the test assete. Aer samp nalsis le started by inserting the test ‘cassette and the oartidge ino the Analyzor Tho Aralyzortranetors the sample tothe lst cassette, where te test development is started, Tost! ‘The sample Interacts wih microparticles coated wih antibodies and ‘th erugcanugates.on he fest membrane. he samples ug-foo, the anbdioe can rect rey wih he rug carivgts, whet Wages signal on the tt membrane. the sample contain cge, hey Bond iB meer oad wt ern, we ests he fenerated gnal, The Analyzer celects te signal genoratod by! a Specte sample and dendes whether his signal Ongrales OM @ Preliminary postwe (on-negatve) samp. Quatty contro: Sr additonal anibody and antigen reaction independent ofthe sarele {Sintegrated into every teat membrane, When th sample hes boon SudssSely processed, snigodos on the reagent merrsre bond a {he arigons'on the mcroparcles and generate a cordol signal. The ‘Analyst slo detec signal and ts used To Joos wher the {esti vaisorrat vals Drager DrugTest 5000 STK2.5 Precautions and warnings NoTIce For hygienic reasons, use gloves when handing the Drager DrugTest £000 test system ane all sample. Do not touch tho tamper with bare hande before and aftr sampling and ‘observe current hygiene rules ‘+ Faliow proper handing and ceposal procedures. ‘© Open the fo. pouch only immeditaly before use to prevent Sertaminaton ofthe sampler ‘© Do not use the Drager DrugTest 5000 STK if the foil pouch is ‘anaged ‘© Donotuse the DrigorDrugTest 5000 STK boyend the expiry dato Pritodor embosseton the pouch. The expiry Gat formated as Vrrvamh eg 2011-01 means the Drager DrugTest S000 STK should not bese ater the end of January 201% ‘©The Drager OrugTest 5000 STK can be processed only with tha Drager GrogTest 5000 Analyzer. c 3 Testing 3.1 Tost preparation and sampling © Ensue that he test subject nas not had any substances ke fg food, chewing gum or tobecza in the mou fr at last SBrnnutes bere santng- ‘© Moke sure that the ambent temperature is between +5°C 0 otc'and ‘the lave ar humidly is" between Shand 26% lave humid + Mae sur ta he pactages tat catigee ret antent temperate wal for tSmindes To. achieve tomperature ‘equalisation i cessary). +. Remove the stely ap wih cartide rom the sampler ofthe tost acecte (Pip. 1) anole the tet easeote tote tet suojee Keep the Safiy cap wih carte 2. Inte! the tex subec: fo place the sampler inthe cheek and more carefuly rors one aie ofthe mau fo he ther (Fg. 2) ‘Tho teat subject must not chew or suk onthe same. Waten the samping proces «© Asuiclnt snp willbe colecte witin 4 rieues. the sample ‘tums inalr shows bho belore the 4 minutes have peed, the samping canbe anded (Pi. 3) tthe sample isnot analysed immediately afer thasbeon ken, make Sure folow ine nsiotons W Secbor a 17 “Geayed anayoe™ 3.44 Dolayed analysis H Norice Results may be invalid or incorrect maximum storage times are nat observed. If the saliva is not analysed immediatly after the sample has been {aken, the Drager DrugTest 5000 STK can, be stored at room temperature up to a max. of 4 hours (confirmation of THC) or & ours (Confimation ofa other drugs). The safely cap must be planed back alder ints cage, Remove the safely cap from the ‘Sampler holder again before analyst Dréiger DrugTest 5000 STK Testing 3.2 Test procedures o NoTICE ‘Qbs01ve tho nstrutios for use of the Drager DrugTest 8000 Analyzer 3. Take te test cassette with the sample fom the test subject Open the Analyzer door and insert the test cassette Ino. the fel tof Te Anabear ul Haun chs Io peeten i. 4. Remove the carpe rom the salely cap ad inser the cartidge th top slot ofthe Analyzer unt t audibly clicks info postion (Fig). 5. Close the door ‘The Analyzer automaticaly tans the analysis. On completon ofthe analysis, the Analyze" displays the results for ‘every tested substance on the screen. Note the ciepay. 18. Remove the test cassotte with the cartridge after the analysis and spose off (Fig. 6). 3.3. Confirmation of results ‘The Drager DrugTest 5000 test system is a qualtave measurement procedure. For a confimed resulta second sample mustbo taken and Snalysed by an accredited laborair Te the secon sample yh a caleston system stale for salva Samples (e.g Drager BCD” 5000 (order no. 83 19 910). 4 Interpretation of results (On completion of te analysis, the Analyzar dispays the: results for, ‘eve tested substance onthe screen See the Insvuctions fr Use for ‘davon detals onthe operation o he Analyzer. Data management ‘fer tho analy, th et rents ae show onthe Anclyzr cpl ‘and saved in tha Analyzer memory, Al data can be printed ou with tne Srager Mabie Pre For more ination on the deta manager pions of the Analyzer spe the Technical Manual for the Drager ‘Brugtest 5000 test system 5 Quality contro! eas ga aaa ce eas en embetter crt ewe os ae Be ante ee re cae a a of met Se Fada ses wc 10000 Presine 30000 Prenton 100000 SterAmphetaring = Opiates related compounds ngimt} Sie} Methamphotar 100000 e-Monoacelvinorhine aa Tramine a Codeine 35 Diyeroeadsine 20 ‘Methamphetamine related compounds {nom Hyerecedene 20 Chlorocuine suphate "0 | Hysremorphore 2 Ephedrine 30000 Merphine 20 Feniloraine 300 Morphine 38-b-loeroige a NBDE 35 Nalophine 35 NDA 00 Naloxone 7000 MOEA 700 Noreogene 4000 MO 75 Nomorphine 2000 Procaln 7000 Orxysodone “000 Fropyhexedine a Peeudoophedine 70000 Benzodiazepine related compounds Ingimt) Le at iaiearepa Gi Rantiine 7000 ‘iprazolam 70 ‘S--Metheatinone 4500 “Bromazepam 70 Stemi oc000 Chlorazopoxdo 3000 S(¢yMethanphetanine 3s nazar 1 Desalyturazepam 70 Methadone related compounds Ingimty Desrethyunrszepam 70 iphennyramine “2000 Diazepam a 15 EDDP_ 7000 Funirazeparn 20 THAN 7000 Furazopam 3500 Matadors 20 ape 200 Pheniramine| 7000 Widazciam oy Ketamin related compounds traf) Noriazepam sone ‘xazopam Prazepam Temazepa77 Tesco - Acoiyisaloyc acid Ascorbic acid Catere THC related compounds mgmt oe Cannabco 0000 ore Cannabnel 350 2 3 Carbory-deiae-THO) 2 TTHO-OH (Tt-Fydroya-deta8-THC) 70 OP aT.787 3700000 WHI 100000) POP Drager DrugTest 5000 STK13 Clinical Performance Cocaine Cocaine-Equivalonts Reference Sample contains Driigor DrugTest 5000 ‘army <1 14-20 20-25 >25 a 1 ° 2 6 1 ° 2 GEMS Citak 14.0 agimL Opiates Morphin-Equvalents Reference Sample contains Drager DrugTest 5000, Teal] <4 4-20 20-2626 postive 3 4 o a “negate COC Rgeomank 52% GEMS Cute 140 ngmL Benzodiazepine Diazepam-Equivalents Reference Sample contains rigor DrugTost 5000, TogimLy <105 105-15 15-195 >19.5 positive 2 1 1 16 neg 36, 2 2 1 Agreement 854% GC-MS Cito 105 Agim. ‘Totrahydrocannabinol Detta-9-Tetrahydrocannabinol Reference Sample contains Drager DrugTest 5000 ingly 35 35-5 5-65 55 postive ° ° ° 25 negative es 1 0 6 ‘Agreement 826% ‘Amphetamine ‘Amphetamine-Equvalents| GEMS Gutoth 35 nai Reference Sample contains brag ast no ‘rtm ae fang eis t arheei Sk aaa case ebm, ReoI OTe a wet ‘Methamphetamine Methamphetamine-Equivalents Reference Sample contains riger DrugTest 5000 Tnofmiy 390 postive 2 8 4 2 “hegatve——SCSC~ RSC‘ @ ota comprise cca and ped samples Agreement: 87.3% GC-MS Cutoff: 210.0 nglmt. This Test Kits manufactured using proprietary technology created by Eptlomics inc. USA. Té - Reproducibility Date BatchiResult 08/08'2008_ARZH-0061: No postive at 0%, no negatives at 250% and 400%, TBIOBTAOGE ARZH-006!; No postives at 0%, ro negatives at 250 % and 400° “roaRO08 — ARZHDOGT: No postives aC 0%, no neGRINES at ipsra0ee — ARZFFIOBT: We Te 73CE Diesive ssrrarec RevalstraBe 1 723560 LUbeck, Germany Phone+49 451 882.0 Fax +49 451 882 20 80 wwn.draeger.com J Driiger Safety AG & Co. KGaA. De Cee Cac i flier ery Phone +49 451 88 oo ugust 2011)