TORKAK ME.KAL
Transkript
TORKAK ME.KAL
TORKAK TURK AKREDiTASYON KURUMU taraflndan akredite ME.KAL DENEY RAPORU TEST REPORT Karyagdl Sok. No: 14/1-2 06690 A.Ayrancl - ANKARA Tel (312) 4419208 Faks (312) 440 25 38 MEDKAL Laboratuvar MUdUrlUgU KIM MOh., Dan., Egitim, It;: ve DI~ Tic. ltd. E-Posta medkal@klm-tr corn Web Sitesi www klrn-tr com Deney ve Kalibrasyon Deneylarihi Laboratuvarll 02.05.2012 Deneyi Test and Calibration veyeri I Dale and place of test: yapan Laboratory: Raporlarihi ve no'sul I Responsible: Genel Yogun Baklrn I Test done by: UmitYARALI Cihaz tammll E. Ekrem OZeAN Description: Seri no I Serial no: Hastaba~1 MonitOru 5513698661 imalatt;1 I Manufacturer: Modell Model: DRAGER INFINITY Cihaz sahibinin adl-adresi I Customer: S.B. KE<;16REN EGITIM HASTANESI / ANKARA Kullamlan denev Modell DATREND Tanlm Elektriksel AMPS1 DATREND OXITEST AClklama: Denoy I Test taraflndan Parametre Method: realize fakltiru esas allnarak and/or NRS (National ljartlan Sed no I Serial Geyerlik no 1699GM300 Tesl Gihazi (') Nisan 13 PS081 00087 Temmuz 9143013 (SP02) Temmuz 09020035 EN ISO 9919,TS EN 60601-2-27,TS 12 :;;ubat 13 DOS09031029 Analyzer(") I suresi Due date 12 :;;ubat 13 EN 60601~2-30, gore yapllml$tlr. Deneyde edilmi~ k=2 ortme Standarts) Cevre I Description Test Cihazl (•••.) EN 60601~1,TS standartlanna 95% with the coveragefaclor - (izlenebilirlikITraceabilitvl: (") Pulse Oximeter DeneyTS Metodu Standards) used NIBP Analyzer{"') KIMO HD150 TS EN 60601-2~34 Guvenlik Hasta SimulatOru BP PUMP-2L 4055/12 standards Model VISTA Sipari§ no I Order no: VE ARASTIRMA standardlarilTest SPL GM300 FLUKE Dale of iS$ue and no: 02.05.2012 Sorumlu kullamlan birimler olup, hesaplanml~tlr. Reference cihazlann 9Ikl~lan; testi yapllan I The outputs Standards), cihazdan NIST (National alman bilgiler of the test equipment compared with measured Institute of Standarts) Ue klyaslanml~tlr. which data. are basic units ve/veya Oll(um realized In the calculations NRS (National belirsizligi by NIST of uncertainities Reference %95 guvenlik (National seviyesi Institute confldance ve of level is taken k=2. I Environmental conditions: Sicakilk I Ambien! : 23 +/~ 2 °C temperature : 50 Nem I Humidity S'cakllk dengelenme zaman I I Temp. stabilization • Kalibrasyon cihaz'n1n IzlenebiliriiOi Almanya S.P.L. Elektronik uzerlnden PTB (Physikalisch Technishen traceable by Deutschland S.PL elektronikthrough PTB (Physikaii schTechnishenBundesanstalt) •• Kalibrasyon cihazlnln izlenebilirli!li Datrend Systems Inc. uzerinden Datrend Systems Inc. through NIST(National InstituteofSlandards) time Bundesanstalt)'e NIST (National Institute of Slandards)'e +1-10 % : 30 daklmin uzanmaktad,r.! uzanmaktad<r.! The calibration The calibration equipment equipment are are traceable by ••• Test cihazlnln izlenebilirliOi MEOKAL- KIM Ltd. $ti, iizerinden PTB (Physikalisch Technische Bundesanslalt)'e uzanmaktadlf.! The test equipments are traceable by MEDKAL-KIMLtd. $ti,through PTB{Physikalisch Technische Bundesa nstalt) . •••• Kalibrasyon cihazlannln izlenebilirli!li UMS (Uzmanlar Melroloji Servisl) iizerinden UME (Uiusal Metrolaji Enstitiisiij" ye uzanmaktadlr. I The calibration equipment are traceable by UMS Ltd, through UME (National Metrology Institute). Deney sonu~fan,yukanda bifgileri veri/en cihaza ait ofdugu beyan ofunur. Experimental results are concerned with tile device whiCh the informations are given above Bu sertifika,laboratuvann yazllI izni o/madan klsmen veya tamamen kopya/amp t;oga/il/amaz. Imzaslz ve miihiirsiJz sertifika/ar get;ersizdir. The certiFicatesIJallno/be reproduced partially or fully wi/haut tlJeperm issionof/heiaboralary,Callbra/ioncertmcateswi/houtsignMureandsealarena/valid, Not: Kl.F.01/09 Rev.No: 03 Sayfa 1/6 Oh;iim I Raporu Measurement Report DR-12/05/141 Marka: I-SP02 Model: DRAGER Testi I SP02 INFINITY VISTA Seri No: 5513698661 Test A) Performans Testi I Performance Test 60 BPM 60 BPM o 90 % 90 % 0% 95 BPM 95 BPM o 90 % 0% 45 BPM 45 BPM o 80% 80 % 0% 2,107 o 1,789 90 NablzlRate 130 BPM 51"02 Nabl~fRat~ B) ALARM 130 BPM 97 % 96% 75 BPM 75 BPM 93 % 92 % 90 BPM 90 BPM BPM BPM BPM -1 % o BPM -1 % o BPM 1,133 2,325 1,440 2,325 1,024 2,457 1,257 2,369 1,393 TESTI 5P02 (%) AltLimit UstLimit I'] I'] MEDKAl 0/0 BPM - KiM Muh., Dan., Ie ve AltLimit I'] DI' Til;. ltd. OstLimit I'] Sayfa 2/6 C)l~iim Raporu 1 Measurement Report DR-12105/141 Marka: DRAGER 11- Sol Model: INFINITY VISTA Seri No: 5513698661 Testil Respiration Test unum A) Performans Testi I Performance Test 1,0 Ohm RBase:line: 15 RPM o RPM 0,936 30 RPM o RPM 1,133 40 RPM o RPM 1,301 1000 Ohm RPM 30 RPM RDeita 1,0 Ohm 1000 Ohm 40 RPM 1,0 Ohm 1000 Ohm B)ALARM TESTI SP02 0 MEDKAL NABIZ (%) AltLimit - KiM Mlih" Alt Lim'd OstLimit (BPM) Ost Limit 0 Dan., i~ve 01$ Ti~.ltd. Sayfa 3/6 ell~um Raporu I Measurement Report DR-1210S/141 Marka: III • EKG Testi' A) Performans Model: DRAGER INFINITY VISTA Seri No: 5513698661 ECG Test Testl J Performance Test 1'' 'i>''~jI'' ., V"o. NSeV,',,'O IAdu" , ~~R."','a'" ,!P'dial'''' ~:::~J 30 BPM o BPM 0,936 60 BPM 60 BPM o BPM 1,133 80 BPM 80 BPM o BPM 1,301 100 BPM 100 BPM o BPM 1,488 120 BPM ;20 BPM o BPM 1,687 30 BPM 180 BPM 180 BPM o BPM 2,325 220 BPM 220 BPM o BPM 2,769 240 BPM 240 BPM o BPM 2,994 300 BPM 300 BPM o BPM 3,677 30 BPM 30 BPM o BPM 0,936 60 BPM 60 BPM o BPM 1,133 80 BPM 80 BPM o BPM 1,301 100 BPM 100 BPM o BPM 1,488 120 BPM 120 BPM o BPM 1,687 180 BPM 180 BPM o BPM 2,325 220 BPM 220 BPM o BPM 2,769 240 BPM 240 BPM o BPM 2,994 300 BPM 300 BPM o BPM 3,677 ~l)~lu;·.f·.~E!~~lt 10 Hz 2 H, 0,125 Hz 2,0 Hz 0,8 mV 121 0,5 mV 121 0,5 mV 121 0,8 mV 121 2,5 Hz D) Arrythmia: 1,0 mV Atrial Testi' Atrial Testi' Ventricular Test $QI:Jk.l~'~~lIlt 2,0 mV B} Arrythmia: Ventricular 121 Test 121 o 121 o MEDKAL· KiM Muh .. Dan .. Ic va DIS Tic. Ltd Ol~i.im Raporu I Measurement Report DR·12/05/141 Model: Marka: DRAGER INFINITY VISTA Seri No: 5513698661 IV - NIBP Testi I NIBP Test A) Performans Test'l! Performance Test .," ,;OJ; ••••~J~'M'~ 60 mmHg "".i' 63 mmHg 100 mmHg 65 mmHg Aj~~'~i~ 2 mmHg 100 mmHg 150 mmHg -1 mmHg 195 mmHg 1,468 3 mmHg 1 mmHg 251 mmHg 215 mmHg 1,062 4 mmHg 163 mmHg 149 mmHg 255 mmHg 1,253 2 mmHg 196 mmHg 166 mmHg 0,995 1 mmHg 114 mmHg 101 mmHg 200 mmHg 1,117 3 mmHg -1 mmHg 149 mmHg 116 mmHg 0,944 4 mmHg 90 mmHg 81 mmHg 150 mmHg 1,044 -3 mmHg 116 mmHg 93 mmHg 80 mmHg 0,915 4 mmHg 79 mmHg 63 mmHg 120 mmHg 0,998 -1 mmHg 96 mmHg 76 mmHg 0,874 -3 mmHg 51 mmHg 50 mmHg 0,927 -2 mmHg 82 mmHg 60 mmHg 211 mmHg 191 mmHg tm~rtaihfu -1 mmHg 1 mmHg 29 mmHg 80 mmHg .•• 4 mmHg 41 mmHg 40 mmHg 30 mmHg a91ii'Si~k} ••ili~~~ ,V.'M 56 mmHg ~ 1,253 1,743 4 mmHg 4 mmHg 1,444 B ) CUT-OFF TESTI C) Man$et Baslnr; Azalma HIZI Testi { Cuff Pressure Decrease Rate Test 4,00 mmHg D) Alarm Test ALT LIMIT 05T LIMIT MEDKAL - KiM MOh., Dan., It; ve Dl§ Till. Ltd. Savfa 5/6 Ctl~(jm Raporu I Measurement Report DR-12/05/141 Marka: v . Sicakllk DRAGER Testi I Temperature Model: INFINITY VISTA Seri No: 5513698661 Test T1 Clkl§11 T1 Output 30,0 "C 30,0 "C 0,0 "C 0,311 35,0 "C 35,0 "C 0,0 "C 0,311 37,0 "C 37,0 "C 0,0 "C 0,311 40,0 "C 40,0 "C 0,0 "C 0,311 42,0 "C 42,0 "C 0,0 "C 0,311 Alar-rnTes{i MEDKAL - KiM MOh., Dan" icY. 0" Ti~. Ltd, Say!a 6/6