“ DIAGON’ Solitons beyord imagination Ah Sobo4 a, D-CHECK D HEMATOLOGY CONTROLS Proauct NAME DCheck D L: D-Check D N; D-Check D H: D-Chock D 2,SL; D-Check D 2,5N; D.Check D 2,5H; D-Check D 3L; D-Check D 3N: D-Check D 3H, D- Check D 4; D-Check D 4N; D-Chosk D 4H Cat. No DDC-18T2L; DDC-1812N: DDC-IST2H; PDC-1872,5L; DDC- I8T2SN: DDC-I8T2,SH; DDC-ISTSL; DDC-IST3N; DDC-I8T3H, DDC IsTL; DDC-18T4N; DDC-L8TaH INTENDED USE (For in-vitro diagnostiesuse only) DeCheck D is a contol designed to monitor accuracy and precision of sutomated and semi-automated impedance type hematology analyzers. Please ‘refer tothe assay able fr specific astrument mel SUMMARY AND PRINCIPLE iis an established iboratory practice to use a stable control to monitor the perfomance of diggneste ts. This contol is composed of stable materials that provide « means of monitoring the performance of hematology blond eel counters, Tis sampled in the same manner as a patient specimen, REAGENTS, D-Check D is an in vito diagnostic reagent composed of Human and rmanvmilian erythrocytes, simulated leukoejss, and simulated platelets Suspended in plsme-ike ud with preservatives PRECAUTION eCheck D is intended fori vito dngnostic use oly by trained personne WARNING: POTENTIAL BIOHAZAROOUSMATERIAL For vito diagnostic use. Each human doverlunt use inthe preparation of {is product hasbeen tested against HBsAg, anti-HIV 1-2, anti-HCV, an TP by CEomatked seresning test 320054110. 82003-11113) Deeree of ‘eats Minisey> and have been found NON REACTIVE, Because no test method ean offer complete assurance that infectious agents se absent, this material should be handled es potently infectious. When handling or disposing of product, follow the FU-OSHA good practice Information about prevention and protection in the healthcare sacor r oher equivalent biosafety procedures, [STABILITY AND STORAGE, Store D-Check D upright at 2 - 8° C (35 - 46° F) when notin use. Protect {bos from overheating and fressng. Unopened vile are stable through the expiration date Opened vis are stele for 30 days, povided they ae hand led properly INDICATIONS OF DETERIORATION ‘After mixing, product should be sila in pearance to fresh whale blood. fn ‘mined tubes, the supematant may appear cloudy and reds; this normal tnd” does not indicate deterioration. Other digcolortion, very. dark red Sopemetant or unacceptable reslis may indeat deterioration, Do not usethe product f deter ieration is suspects, INSTRUCTIONS FOR USE |. Remove tubes from the refrigerator and allow them to warm to room eerste (1510 28°C oF $916 TPF) for 15 minutes before mixing, 2. To mix, hold a tub horizontally benveen the palms of te hands, Do not premix on a mechanical mixer 2) Roll the ube back and forth for 20. 30 seconds; ceasionaly in invert the tube. Mit vigorously, but donot shake. ) Continue to mixin this manner until the red cell are completly ‘suspended. Tubos stored for along time may reuire ext mixing «) Gently invert the tbe #0 ines immediatly before sampling 3. Analyze the simple as instructed in the Quality Control section ofthe ‘Operators Mana for your nstment 4. After sampling: 3) IFube hs been open for sampling, clean res mara from the cap and tube rim with eintfoetssue: Replace the cap tightly, ‘Return rubes to refrigerator within 30 minutes of use Issued: 04-11-2016 Version: (cae EXPECTED RESULTS Verify that the Tot number on the mabe matches the lot mumbo on the tabi of| assay valbes. Assay values are determined on wellmainiained, properly calibrated instruments. Reagent differences, meintenance, operating technique, and calibration may contribute inter labortory vation. PERFORM ANCE CHARACTERISTICS ‘Assigned valuot are presented as @ Mean and Range. The Mean is derived ‘om replicate testing on instruments operted and maintzined according tothe ‘manufacturer's instructions. The Range isan estimate of variation between Inboratones and als ees ito account inferent imprecision ofthe method. ‘Assay vale ona new [ot of eontol shouldbe confirmed before the new lots tito routine use. Tes the es fot when the instnment in good working border and ust control results onthe ol! lot ee acceptable. Te aborstory's recovered mean shovld be within the assty range. For greater contol sensitivity each laboratory should esblih ts own mean and ecceptabe range and periodically e-evaluste the mean. The laboratory range mey include values outside ofthe assay range. The user may establish assay values nt ited on the Assay Shee, if the contol i sutable forthe met. LIMITATIONS ‘The performance ofthis prodt is assured only if tis properly stored end used’ ss described inthis insert. Incomplets mixing of & tbe prioe 10 We invalidates both the sample withdrawn ard any remaining materia inthe tube TECHNICAL ASSISTANCE AND CUSTOMER SERVICE For technical assistance or addtional information please eall your dealer ot local distributor. I there is no, you may cll DIAGON Ltd. Technical at 36 1-369.6500, ‘Symbols invite oo [em Be lave cose @ [ewan YS ee ee ToT] | pacncoe | CE | cemk REF) |e tal sso Barossa, 48-52. Budapest Hngary-1047 wae digo com [wo] CEDIAGON’ D-Check D Soto bona mapesion CONTROL ASSAY VALUES AND EXPECTED RANGES. LOT: 1S0601 Vizsgalati értékek és vérhaté tartomanyok £3 05-12-2019 Instruments: Diagon D-Cell 60, D-Cell 60CS; Mindray Bo-3200, BC-3000Phs, BC-2900, BC-2800, BC-1800 CL CONTR Trea ceo a oraneter vor teseor [or nent to re Mean + Limit ik Mean & Limit eed ‘Mean Limit eee an een van feo qws0n | tate | ansow | aerem | senae | sa von cot raza | core | vwazos | see m7 | aassea | ams o nas | oom | ome | oweu | owes | osm rw nasxo | a2-a2 | wera | cee ae | moseas | ao0-s0 ns ozazooe | oe -can | osszcoo | ass cae | oss +006 | on asm lev maseo | rae-ssa | aseeo | mois | oreo | moore he masan | axo-sie | aurese | asoeoas | ocean | mone fore a sisess | moses | acreas | ano aoe | sereae | oases ™ vase | sco | see | amos | one | maa rows areas | wrear | ersee | aren | arewo | anton Pe 1 wee 0s | anes wes 276 | snes lwev 1 tos #30 76-138 | 5230 75-135 | 15230 75-138 lpow % wsea0 | to-s2 | r2e90 | 12-12 | rs2ea0 | 02-12 pcr % oon 20.050 | os - 0134 | ozs 0.too | ote - 0.902 oo. 47 Bazar 1a 28 0.540 ¢ 0.200 levune 10% qanos Eran) Te 54 2021s 05-38 tare ao 92-170 oe ce o2no2 Jorane 10%. 1aeos 00-04 o9s07 02-18 07-18 50208 42-58 pwns vaaeta1 | 52-604 | 259201 sarees | 22-252 laox ” o4e70 aaa | sx2200 22-22 | tosar 22-196 loranse wast zs-st1_|_aozne | sos-755 | maze | s8-a10 DIAGON Ltd tol cree, [i] wo C€& DIAGON’ Solutions beyood imasination ASSAY VALUES AND EXPECTED RANGES Vizegilati étékek 6¢ virhaté tartoményok D-Check D CONTROL, LOT: 10601 bg 05-12-2019 Instruments: ‘Mindray BC-2800 VET CONTROL “Low CONTROL “Norma CONTROL "High es or 150601 tor: 150601 tor 15060 me sum | Ronee a Fase Pome zum | Ronee aration Veeaton variation wee 1 Bre os 22-32 Tae 10 0-00 | woeze | ea. m0 ise ola 18205 ro-a0 | uocos | wa-ue | te2200 | wa- 90 ot wes ro. a0 woes mew | ies 74 - 190 es % meeso | io-25 | sesso | se-aa | sess | 0-59 ue 0206 20.030 | 0.176 - 0.238 | oes 000 | ost -os2s | osu 2 001s | oes - v.50 ev " reo | 71-051 | osaeso | ros-ora | asses | ws- 005 ac 0 msre1ss | 23-29 | acess | 22-ma | wesse | 20-06 cnc iat, searas | sus-ai | sores | sis-aoe | ssse40 | cor- aos ot eae 48 ssa | areas gra s00 | 35 2 48 sor - «03 Pe 1H 72 m0 | 208 wt | sae ao DIAGON Lid 48-52,, Barass Str Budapest, Hungary 1047 [ w> CE** DIAGON check D ASSAY VALUES AND EXPECTED RANGES LOT: 180601 Vizsgalati értékek és varhato tartomanyok B 05-12-2019 Tnetrumentsr ‘HBX MIGROS Sereis SIEMENS ADVIA 60 CONTROL ow? ‘CONTROL "Norma a tor 120008 tor Ta060r wor = time | Pwo time | | en 2 ti ation Veiaion freeware | aanon [19-20 | vaste [ea-ea | vases [wr wr rac omer | aee0m | aae-2m | asa0m zoao | aac ice * warea0 | wer zr | sooees | severe | aoeeas | asa sts a axo1 2000 | o101 oat | oaeo2aoss | oaze oats | anes +00es | o4st - ost ev tk moze | oro-cre | srazeo | re-er | orosco | ars- ae ce masse | aa-no | asers | asr-ma | stosse | ar2-oe picket wees | as-a21 | soseae | ars ait | sszese | 204-00 ow wes | ses-aar | sores | ats-et1 | asec | 200-40 pe wer | saz | wwe | mse | wo-wo | west | aon row wseso | 72-123 | wees | r4-104 | imseao | 75-108 per cose 20050 | oor catia | oreesaoo | o0ee - 0204 | aoe 20200 | 020s - once rer mt oszeaso | ozs | seczro | osr-ze1 | sore 200 | 208-000 fwpae —vovacavon | aaz0a | to-1@ | 2zz0r | ss-aa | arama | 20-40 luce torueatom | ose0a | oo-o6 | sszoe | os-21 | seeze | 10-74 lone torucaron | oos0z | 06-10 | srzoe | ar-4s | soezr | c2-n18 vn seats | a2-ro | szeos | m2-2 | zac | 152-2 lwo rseer | ea-7 | wezeor | or-ara | xoens | 15-8 cnn x nosso | wo-aa | sorerso | sores | sae ras | ano ee DIAGON td ul maa net (yj wo CE«> DIAGON’ D-Check 0 Solutions beyond imagination CONTROL ASSAY VALUES AND EXPECTED RANGES LOT: 180601 Vizsgélati értékek és varhaté tartomanyok 05-12-2019 ABX Pentra 60 Series, Pentra 60C+ Series, Pentra ES60 BECKMAN COULTER AcT SDIFf Series CaSO Taw ZONTROL “Rew? ZORRO. gh a or 700 or 087 ior S007 ee ee [ec wien | 20208 aa aa eaeto 73-93 199428 Wa 228 fro ca vom | asszam | aa-anm | sso | aa ae | swsow | sa om a gt rasos | aaeze | specs | mass | aseos | ars sa on aes wm | wore | swe | woes | 5-01 nt wereae | ser-21 | oszeas | siz-0o7 | mozes | as os ue o1ei 2000 | oset- 0221 | oar sae | osir-asor | o4z0 200% | 042s - 051s te mesto | os-me | rzezo | nz-ss7 | moez0 | 100-e00 ln masse | 25-31 | soseae | ase-sta | azarae | ans ons Iwona sesses | s4o-0s0 | soseas | oio-06 | ceoese | aur aa7 n ssea | sacs | ome | soa | omew | oar rowev _% wszso_| sas | masse | naa | oreso | tor-m7 im oreo | res pm | eco sam [loc | ore | go wy te arz0 | 1-1 | 0230 | 0-120 | eoes0 | 50-9 DIAGON td ull buanore Meany i vo C€> DIAGON Solutions beyond imagination ASSAY VALUES AND EXPECTED RANGES Vizsgélati értékek és vathaté tartomanyok D-Check D CONTROL LOT: 180601 DIAGON Ld 48-52,, Baross Str Budapest, Hungary #1087 by 05-12-2019 ABX Pentra 80 Series, ABX Pentra XL 80 Series BECKMAN COULTER AcT SDIFf AL CONTROL La CONTROL "Normal —— = ior ah Tor a wae Toman | 29208 24-34 [sse10 [73-98 730 225 Wa - 224 oc wohatavo% | eaos0z | amare | asoaas | ama | seszoad | sas ee ek raz0s | 69-70 | uosoe | oa-ue | weozae | as. 0s on nes wo» | wee | we | woze | e-a1 ror 2000 | 0101-0221 | oan ean | 0217 o4cr | aro 200% | os - oss uv ot msato | ose-eee | rraro | rt-o57 | soete | mo- 00 woe masse | ass: | meess | an-sa | oeae | ms- ant wore sorts | 0-0 | meses | xo-ae | weese | ar-ao7 a waza | soos | wore | soa | sore | on-ar nowov wszse | ns-as | warso | sa-2e | reso | wor a7 Pe we | ese wr | mezes | woo | eres | aaa wey eee wa | ooes0 wo | soeso | so-ne [ij] vo CE& DIAGON Sdluion beyond imagination ASSAY VALUES AND EXPECTED RANGES Vizsgilati értékek és varhaté tartoményok D-Check D CONTROL LOT: 180601 bg 05-12-2019 NIHON KOHDEN smear MEK-7222 (1) CTRL CONTROL Nore” CoRR. paraneter or 1605 ra 06 iz em vine tnt |e pttin stem Pamee se | fresh wares [wer | vez | os-08 | waste | 1-000 eo aa zezow | aa-zm | acazos | aa-am | swvsoa | aa 60s ott rasos | oa-79 | ssseae | raz-ua | rzonae | ona cur a nes wo | mse | teem | amee | meter uw oa saom | orro- oz | oase roots | eve- oan | osis 200 | oats - ose lev mazco | me-o50 | esaero | mo2-c22 | mesa | s0-sre fen a masse | ms worse | as-o07 | siase | ao. as wc ssszae | sor-0os | areas | ma-29 | osoass | so2-s00 a ase | oor-an | sree | wo-w0 | stose | accom rowev rwasso | naar | ssoeso | wo-moo | ssseso | mesos B wh wees o | aos | ssa | anaes | sooo me bev on rraso | a7-wor | raeao | ee-19 | aveae | s0-n10 ow x wsses0_| ross | zasso | ov-s54 | aseao | oo ies (1) Assay Values were obtained on analyzer using DIAGON reagents (1) DIAGON reagensek haszndlata soran kapott értékek. DIAGON Lu. 48.52,, Baross Str. Budapest, Hungary H-1047 [i wo CE« DIAGON D-Check D Solutions beyond imagination CONTROL, ASSAY VALUES AND EXPECTED RANGES LOT: 180601 Vizsgélatl értékek és vrhaté tartoményok iS 05-12-2019 ‘Instruments: DIATRON Abacus, Twincell, Minicell, Arcus, CONTROL "to ZONTRGL Noma CONTROL Tag ae tor 1aoeor tr 150608 oF 72001 wean stmt] am [en ume | Tan me | Re wacom aoe | aren oo Tee toe | raaam | ws 195 Rec tata a we | 2682 0.20 arisoas | 408 S08 aaa 832 le ok s8208 wreor | 120-204 139-177 a woes are? 129 - 104 1-97 rt * ns#20 woress | s62- 482 sot oa uw ais + 0.000 car +005 | oe - 0482 wok woe28 mozse | 22-208 pcre ga. meee siae4e | 209-20, a 200 #48 aiseat | 205-01 Rowev mmes50 waeso | 123-223 rows te uzee0 sesseo | 170-060 pr woe | eae cares | tera yey ar230 areao | et- saa row 390260 ssoeeo | ao-as vue womawn | arzose vas20a7 | as 208 wor totanatorn | azes 022 oese0s5 | 010 120 crane tohuca ron | 1202098 sose07 | 421 580 uve sore8e noses | 154-28 oe nese7 sosts | 12-167 crave 52187 corns | see- 704 DIAGON Led wal 48-52,, Baross Str. veer [J vo CE&DIAGON Solutions beyond imagination D-Check D CONTROL ASSAY VALUES AND EXPECTED RANGES LOT: 180601 Vizsgalati értékek és varhaté tartomanyok §3 05-12-2019 Instruments: DYMIND DH-36, BIOTA Vabio360 ZNO. a en ior T0008 or 7001 Tor rer von a ume | erm Pan a ume | [oon ume | viene soos | aoe-ooe | nese | ie-m0 | sew | co-a02 onan, aisema | 27-38 | cassis | same | mzenr | ens oro lon nazt2 | 12-00 | seaeo | asco | sez | os-a2 ivurne so rseeoae | soe 180 | serzos | ss. 20 | aeracor | ise a8 crane tt roseose | 07-140 | sczsors | azr-s77 | so902200 | see 1590 wor toh ozz20 | oor-car | ososoa | 008-00 | oases | aos-o7 ao areca | am-a0 | anicom [as an | soeca ear am juco tt rasoe | os-e0 | raseor | warms | seos | rza- mo act mses | wo-z59 | aseeso | mo-ae | srzeas | s2-e22 uw ea 200m | or - oa | case +0o0 | oase 0470 | corre cous | oss - onze ev usae0o | mo-w2 | cosseo | oe-o56 | orzeeo | on7- as7 Mens aseae | as-as | anreae | ae-s28 | oosese | ce aea rowev useso | os-r | useso | coms | uosso | o9-s99 rows ft aze00 | wz-s7 | soem | mses | seseio | n0- os re 0 mae | 0-8 | awe8 [nian | ase | ano pov oer est ari [fresco | er eevee | ee ow nseao | ws-res | acceso | n2-m2 | usero | sans crx core 200 | como | cares 0s | o1e-os1e | o4sn +020 | 0250-050 DIAGON ltd 48-52, Baross Str. Budapest, Hungary H-1047 Ci vo C€