2 - Fluke
Contents
1. nn s vate Dee MEMORY JOB sm 108 25 hi 2 uaga 25 A p GND i DIL 1aP ar Si raser TE RESET IS pa uo Jj cn E D I Mit A Cote zun ved Jane so FXDBE TE An xt1AI03 EMABCET ERRECET TEPEE A en aa ene Pran OT CPU Er Im u Di was sere mica END END BABA EE m Sech KERK DEE T a a a I t 1 t ENABLED serge ENABLE UE En EE ENE STER CLE 2 IH STEP CLK 2 y Tee Wart HERE at men YAA sem H wan Ven EEFE wg dam Se ee S BEES Sgt H DON koa erst cores WI gi R 8 FEST aTa E ama s e o E mest D Lan Am o eoz FENFU 3 t PENAT a ATT pen Jaaa 7 AA kara TBUSY TBUSY anse n Edy Aen cas D n dd DAT EANG D 1018418 3 vr 2 JBZ 5 sia s rana ADA FDT 1818328 a vr et 1 sz MBA 18 Fan BCLK SELK Same on Ranz 2m auge DN w SE Nee H o A 3 H FES Kr KZ 2 AER sae a tana Dour A DOUT vers a 13 fars GC d a E 7 a Ja 1 3 5 188 2 4 ji ji p z Am 3 4 E Pag rm 1188 14 e 7 p EN q deg 3 1180 15 4 YAA cook g E 1180 18 4 El Bot d Elle END H an 28 e 150 x 17 mza EE an 22 1525 VECS SFWZZA IET in JB II 24 EE D Jit 25 1558 D 11 20 nse B s az E EL a E An 2a ausve E A ma c eme A ne an 36 jg un 37 282. csan RED TANF pes pe 2 18 BB S F ar cm WA Ier epps usia Channel MPX22BB6P 4 Vox AGH Ke Asi ya Ink m E cs wanr Bans VER C531 Sa Wu a805 P Er 2 t Ok B05 E m De AND tt ous Channel 2 uall NPXZZUDGr SE Voz acho Aa nem WA ek Depp A gt 0518 In eps vr Bai 2525 sat GF DC mane oaas 2 h a csza D SOAR DEBS IB NF BEBS ABHD F 7 ver var i TS LEES vr L aszz Ba uza pl Lu 1 ti Ds ml CCE 5 ig aoe LMHSEM2 H 2 ER E E a El Jaze ro vg u I Aszs E H i Al Rez I wa as 8 Es AGND 2 AGAD E voga a e csaa E WANA pes mans pes i var ngoz ag ar Vagal a E 3 DETTE E AVEE der re eng oe LET wens Lana ner ur tt at 2 PTA Hama AEFIN 5 k K re AGND AGND kuga e ETS E II 1 E lama HOLE N Laf a il F es AMBAHZ OFM SU Raza MELK OUT y E 3 A ol com ail E A a gt 3 R H zart enen d dat St st H 2 pur mer SNB li BTARDET 2 ev Fach e a dire Roy 5 Asp AND mem at 7 usea a RESET ADFFAIER k Am AGND GND DESCRIPTION METRON lagu AES VIS Pressure measurement NAME H2BBMDII DRAW ND H2BB 20 15B 12 TATE 19 83 2882 AM Elektronikk AS Box 55 Leirdal REV 1288 OSLO Norway PAGE CEE A 7 A 8 Up
3. WM d BE Ss us 4 DANF 5805 yor HERE NE am END TKDE at Ce ES neng By di DRE TTL R5232 nen 2 A meme END HEER 95 Vi em sf 5 MAXB2I2CEE 1 GND Ca Fe a con Van T T G NF AS85 nur me SE 1 L 0929 1 NF BERES i END PN d x DSBE US7a raLsas END Er a 3 4 a DEE usz a 74LEBS ask g E x DS2E Lazo c 741505 FR A x DS3E US2B D TAL505 NINA por a DS4E usza e T LS S nas a good DSSE uaza r at mg nse e all E DSBE L 740585 SA ya a x DS7E vs us3a F at pb l casa KE IBONF 2885 na TET ka gl I 81 El st E 3 P F H END vegas J L H E AM e EL aaa ELI asaz L pas FL pass af I TRES Se 3 A Spot zu CS usan A ussa a Lasa c Lea F4L885 at ang T4LSES AS END M 1 1840 BASIE ot RES wenns sus Mr BUSYE 1 CG d 1 1 Dsl BASIE R540 z 18K B865 1 END GND DESCRIPTION METRON lagu ee TS Printer and RS232 NAME H2BDBMII DRAW ND HZBB 28 19B8 12 TATE 14 03 2002 AM Elektronikk AS Box 55 Loirdal DEN 1888 OSLO Norway PAS IE A 11 A 12 vn VGE33 uana SG LBIN7 SIE A S A cape l cepa cana A p a 33U I5TD
4. vk ak 5 a Sch S S versa L ER 5 E fe E E a Ea E Dan mn e af af L BSG e ya dg FUE 1 2 11 5 sg y at SFT ID 412 g EE ue Ae fi 50 11 8 A LE m ga np 21 11 lt Ls ar pa 227 na Jie max met LS 41 18 g CCAA 11 20 Pn eeg Haz 257 AE nn ea F s 351 END Feen 2 pro E pa WOES VEKS YCES 3 VERE E Dm PH pranz gl 18 E i E 1 L r md 8 te S En s D Le Bena E psescra la 5 2 Ge He To Taa EE purine L a mu gA S2 ez 82 meng sp Pertra eie BND BND BND 8 m EET TH perse ne la DATA BUS ren LE porer ms as RD E remm ADRESS RUS a HE VE Mi oa GEN mza TU er 4 m 2 A pig mz 2 ER EE ERDEZ ale e SEN L ar Boni Select gio am Swa ge ag S vEES a pep AD aa sa die D DE E SE miie a LI E a veps aL wo BUS MDEE para Ka Gre U I vera 3 El a as u 0 F di ai ro HE eee INEA TIDER PE pater a AS 2 a hd ap va pE za az A az Dr 57 usa za a haz 3 BE Du m DIE Tamaa 33AE az a mur par ap x bd see E name pal ee I oe wus Les bar as OE OF ba vera Gees fee wan P E nn P 77 225 wn E E wm Be m z e ana EN E E une wa EET KA Faso wa CSR A CENT wees 3 A ran 020 SDA E be versa EE B ara 284 i v s g 07 32088 Au an va D GEL 1 8 mas Le S es g a Eu an sift o marc FA SE aa 2 as hasene DIS FEBET Ja wer ravazarcot RE RESET eps gt 18 vers pue SEE 2222832232 De On E Je le babzkaksho
5. AM Elektronikk AS Box 55 Loirdal REY AB OSLO Nor wow ad ili cas 100NF BEDS YvGE3 a A a GHD VEL 28 FADE e Zaa oa a RADI ay H a FADZ CR JE 5 15 23 Aana e a mi ES RADA Es ut YO BUS Tu 13 25 EN 12 15 nr BUEY s D Dr li u DES pap San NS a s a e s LEBE JE 74LVC54AD Jae E ine 1 QA IDS wife Pap vali wna yz ee te e De oan LABU JHB 43 a Ll Le Lie Ls 8 Ps Us We Lis JE te LE le END sit St vecaa la cata WONF BBES 2 voca a a cn na LEDE ao aa gt LEDI ER El 7 LED es IF z LEDa EM m ES LENA amp 5 IE 7 Io ns LCOS sl a 13 25 LEDE mi a Jz E LCD Dr ar CELTT Mit ce do uem F 7ALVES74A08 END DESCRIPTION METRON lagu AUTH SATS Digitel inputs NAME HZB MDI DHAW ND H2BB 20 15B8 12 DATE 12 03 2002 PAGE gor 1 A 9 A 10 versa IDENF 805 d DATA BUS ein pe Hen BB raa Di 3 E AR a DEI Dz EN JP a 262 Da EM 8 L AR 153 D 5 3 D 154 L BUS pe Se R Gen 155 DE EN u DSG 5 pr al Boi LE Per ES can wO oe F VERS 3 LOUE g ja p a E e amp E Ue cria ca Sony K
6. Inlet Drain Pump tion Keys 5 11 alphanumeric keys used to enter information F1 F4 are used to select the functions shown in the menu bar at the bottom of the display i e for selecting the function that is directly above the key F5 F7 are used to select the function or enter information in the message field in the same line Shows messages test results and function menus Inlet connection for infusion set Connection for drainage tube Special function keys for selecting active pump No function on single channel units 3 1 Rear Panel 3 2 lagu s Controls 3 2 Printer PCA2 9 Warning No user serviceable parts inside 60VA g Leave repair to qualified personnel Mains lagu Attention Entretien et r paration internes ne sont autoris es qu au personnel technique qualifi 7 Power Switch Turns power ON and OFF 8 Mains lagu Mains connection for test instrument 9 Printer Outlet Port 25 pin D sub Centronic output 10 RS 232 Serial Ports 9 pin D sub 11 PCA Connectors Interface for PCA pump trigger lagu s display alphanumeric data entry keys control keys and programmable function keys see below provide flexibility and control in testing 3 3 Display Menus and Messages METRe N_ oQa DS METRON QA IDS Ed VERSION x xx DATE DD MM YYYY A amp A JEJEJE C JEJE lagu s display has four lines in each screen The t
7. e Drain the unit until the liquid in the drain tube disappears e Press GO BACK F2 to return to the main menu Cleaning The lagu should be cleaned every six months in accordance with the following procedure Use any of the following cleaning materials Sodium hypochloride 4 solution in distilled water Acetic Acid 4 solution in distilled water Bicarbonate of Soda 4 solution in distilled water Mix the cleaning fluid in distilled water Prime the lagu with the mixture See paragraph 3 4 3 e Allow the mixture to remain in the system for 30 minutes e Drain the unit as above e Repeat this procedure two to three times e Set he lagu on a one hour flow test with a flow rate of 100 ml hr using distilled water 4 1 Introduction 4 Infusion Pump Testing This chapter details procedures for conducting each of the lagu tests Infusion pump testers calculate flow rates from a measured time period to fill a defined volume If it takes one hour to fill a defined volume of 10 milliliters the flow rate is calculated to be 10 ml hr This flow rate is called the instant flow rate The minimum volume detection of this measurement is 10 milliliters since it needs that amount to calculate a flow rate The next instant flow rate calculation may be done when an additional volume of 10 ml is delivered to the measuring device When two or more instant flow rates have been obtained the calculation of a mean flow rate can be don
8. BACK STOP The following parameters are displayed Prsr The pressure in the connection tube Measurement results display max value gt instantaneous measured value gt mean value in mmHg Time The time from test start until alarm activation Measurement results display max time gt elapsed time gt mean time in minutes seconds Bolus The volume expansion within the tube when the infusion pump alarm activates Measurement results display max bolus gt last executed calculation after STOP is pressed gt mean bolus in milliliters e Press GO BACK F4 to return to the previous menu e Press STOP F2 to stop the test Pressure XXXX gt XXXX XXXX mmHg Time XX XX gt XX XX mm ss Bolus 01 XXX XX gt XXX XX XXX XX ml GO BACK START PumpX AAAA e Press START F2 to return to the previous menu e Press GO BACK F1 to return to the previous display 6 Flow Measurement F6 This function is used for entering flow information in connection with the test There are four main displays shown below 3 7 Flow set XXXX X ml h E Press Set XXXX mmHg pet dT XX s BERG MORE START PRINT MAIN MENU PumpX AAAA The following parameters are displayed Flow Set This value is the preset value of the infusion pump All error calculations of the flow measurement are related to this value If the Flow Set value is not entered correctly this may cause a poor presentation with incorrect ove
9. IB NF BADS E nu 1 d El Guo GND END Gun ES E Auge LE LINN7SS a S Cas can cos PE 33041872 pur mme z E sun GND END END Dead BASIE mk i casa f Ler nens oer z Lesa ausrzan Gr via aum sw LR Tr H p H in caan cas bon e pu BHAS IBBALFFZEVS est sa LT aL MBASS4073 i z SHORT FEEDBACK i F gid T Poo 5 ARE E 48 END N en END a KKXA pEED END END LTII7AHYCA 2 1 i u Ze n Bu CEE mre Mi 3 E LJ ran BND at END v r a E D E z Emme Gu E Sein Gut 3 p Jura E H Geng F AB43 core BABE Ze ALA ENF aaas S ee wf kr zra npan 2 ur FD gies Beh ver VDD 2 dr EEE EN apa ha Bu ur 24 ye Lx FE BERK BERS 5 SC DOWN B vom pacaut ak BZ om Rasi Eno D EN TENOR A 1BGPF moer E te Le e 5 MA JE cass EL pass 5 LI Ross vorss J ER Por ll 126k 8885 ee sun rer a ar 2 ar 4 ma mer LE 4 EE nuez na D END PEND Soa LT END ja 3 uasa g MAKSEGEER BND ET DESCRIPTION METRON lagu AUTH VIS mn Power supply NAME HZ2BBMDI DRAW ND H2BB 20 1BB9 12 TATE 12 03 2002 AM Elektronikk AS Bos 55 Leirdal Rev 1848 OSLO Norway PAGES SERA USA 1345 Monroe NW Suite 255 Grand Rapids MI 49505 Phone 1 888 863 8766 Fax 1 616 454 3350 E mail support metron com FRANCE 30 rue Paul Claudel F 91000 Evry Phone 33 1 6078 8899 Fax 33 1 6078 6839 E mail info metron fr GERMANY R merstrasse 22 D 63741 Aschaffenb
10. MAIN MENU F4 to return to the main menu e Press MORE F1 and the following display will appear 3 5 3 6 Language English S Date dd mm yyyy XX XX XXXX EN Time hh mm ss gt XXI XX XX per GO BACK MAIN MENU PumpX AAAA e Press Language F7 to select the language used for the testing e Press Date F6 to set the day month year e Press Time F5 to set the hour minute second e Press GO BACK F2 to return to the previous display e Press MAIN MENU F4 to return to the main menu 5 Occlusion Test F5 The Occlusion Alarm Test is used to protect the patient An Occlusion Pressure Alarm will be activated if the pressure inside the administration set extends preset levels The three main test displays are shown below Flow set XXXX X ml h Alarm prsr XXXX mmHg SC Pump type Standard AER MORE START PRINT MAIN MENU PumpX Reverse dly GO BACK START AAAA e Press Flow Set F7 to set the preset value of the infusion pump e Press Alarm Prsr F6 to set the preset pump value e Press Pump type F5 to select between Standard and Reversing e Press MORE F1 to go to the next menu e Press Reverse dly F7 to set the delay on the reversing pump e Press MAIN MENU F4 to return to the Main Menu e Press START F2 to start the Occlusion Test and the following display will appear Pressure XXXX gt XXXX XXXX Time 1 XXI NS XX XX Bolus 01 XXX XX gt XXX XX XXX XX GO
11. over voltage The serial port has a 9 pin D sub male DTE and is connected to a PC with a NULL modem cable The handshake is carried out in the software The control signals RTS CTS and DTR are connected on the D sub contact The microprocessor unit consists of a Motorola processor with a clock frequency of 16 MHz RAM A D converter watchdog real time clock parallel and serial I O The program is stored in a 128K RAM with battery backup The setup parameters and calibration data are stored in EEPROM in the CPU The LCD display and keypad are connected to the processor s bus via registers The built in A D converter in the CPU is used to monitor the temperature and battery voltage The pressure gauge consists of a differential pressure sensor a measurement amplifier the reference voltage and an instrumentation amplifier The pressure sensor U1B00 is made up ofa piezo resistive element encapsulated in silicon It is temperature and offset compensated It receives its voltage supply from the reference voltage The output signal is amplified with an instrumentation amplifier U1B10 which is a4 x operational amplifier The amplified signal is proportional to the pressure measured and is fed to a 12 bit A D converter U1700 To measure negative pressure an offset of 800 mV is inserted at zero pressure The offset is adjusted with R1 B1B The amplification is adjusted with R1B10 to 4050 mV at 1700 mmHg The reference voltage is genera
12. test interval is displayed Recommended dT from IEC is 30 sec and this is the minimum value to be selected on the lagu Maximum dT is 600 sec or 10 minutes Default value is 30 sec e Press Flow Set F7 and enter the preset value of the infusion pump being tested e Press Press Set F6 and enter in the relevant or backpressure e Press dT F5 if values other than the default 30 seconds is desired and enter the new value Press MORE F1 in Flow Measurement Setup 1 and the display will show the Flow Measurement Setup 2 4 5 Test Time XX XX XX mmihhiss Delay Time XX XX XX mm hh ss MORE STAR MAIN MENU PumpX The following parameters will then be displayed Test Time This is the preset time for a test Maximum testing time is 24 hours Default value is 1 hour Delay Time This is the delay before the first measuring e Press Test Time F7 to select a time for the test other than the default time of I hour e Press Delay Time F6 to set a delay before the first measurement if desired e Press MORE F1 to return to the Flow Measurement Setup 1 Menu Press START F2 to start flow measurement in either the Flow Measurement Setup 1 or Flow Measurement Setup 2 and the following display will appear Mean Flow XXXX X Cum Volume Time Left MORE F1 F2 The following parameters will then be displayed Mean Flow The flow of the liquid volume in infusion pump every second displa
13. DB up DOWN E koa 4 kon KOLI AAA KOLI ES ES KA 4 FOLA e D BESRBRARAE E A H 28006888 aon Lu 5355555555 Dee E K IWER CEE WI i E E LEDE LODO LED LCDI Lenz Lenz Lena Lc03 Lens Loos a Lens Lens m Ay test I ene z Ka opr er 3 oO en oa Leen rer a gt HI Lu gt S un Ai ei E Tao JA E D a 2 gt gt His x a sl el u Ge an se EG RAD DAD Ranz RADZ SE RADA bh Radd D a TETTE a BARARRAN S SE RE El IS TADO x TKDO TIDE 4 TX DOE reno ADB neet AKD E op en bo ibe mar mn e pan remm ep PRINTER AND RS232 mes mue DSIE asw 152E 152E 253E 253E 284 154 155E SSE DS6E app 157E 257E STIER STEE auser BUSYE VEE3 3 vors 3 I ke K pur mes p et Ka ate END vin A Je mor L m ScLK Ye EJs am dt am sar 2 x DOUT ner ce HE a CETTE B a puse MH vaar Fam 1 PENG can l csa CC pu ans F AD7673ARO 4 I usa veca visa Ea chin 5 T l cza 4 EM IDBNF DEDS 74AHETIGOS N GHD DESCRIPTION METRON la gu AUTH VIS Digital WO NAME H2DBMDI DRAW ND H2BB 20 1050 12 DATE AM Elektronikk AS BEE Box 55 Loirdal rev 1885 OSLO Norway RAGE FOR N DATA BUS
14. NS aa God tenes A hon ee ea ee eeh enh es 1 1 1 3 General Information E TON 1 2 o EE E 2 1 2 1 Receipt Inspection and Return 2 1 2 2 MUDA RRE tete AR R Gea EEE 2 2 2 3 Power AA AA Sane 2 2 2 4 ansur lags kassa A Ee 2 3 EE ON 3 1 3 1 Control Switches and Connections nenne nenn 3 1 3 2 la gU S EE 3 2 3 3 Display Menus and Messages 3 3 3 4 Printing Test Reportsss une sue 3 10 3 5 Operator Maintenances sus aars 3 12 Infusion Pump RN KE E 4 1 4 1 Introduction ren A ae Sea 4 1 4 2 Test Pr parations agder ween sere As 4 2 4 3 Occlusion Pressure Bolus Volume Testing mrnrernrernvrnvrrnvrrnvrrnnrrnnrrnnrrnnrrnsrrernrernverseeseenne 4 3 4 4 Infusion Flow Rate and Volume Tespng ernennen 4 5 Control and Calibration serssrsonssonssnnssnnesunssunssurssnssnnsnansnnnsnnnsnnssnnesnnesnnssnnssnsssnssnnssunssnsssnnsnnssnne 5 1 5 1 Required Test Equipment ws aad Ad RL 5 1 5 2 Adjusting the Display Contrast amwamini 5 1 5 3 Upgrading Firmware ss 5 1 5 4 Voltage Control and Adjustment www 5 2 5 5 Pressure e TEE 5 2 5 6 Index Calibracion svin ees 5 3 5 7 Testing Flow Rate Accur cy mini di 5 3 111 5 8 Factory Flow System Calibration ss 5 4 6 Component Functions and Parts eussssonsssonsssnnssnonsesnnssnnnnesnnssnnnsusnnnsnnnnssnnnsnnnnssnnnsnnnsssnnnsnnnsssnnnee 6 1 6 1 Re EE 6 1 6 2 Power kartene a Ba RE 6 1 6 3 Printer Output a AAA AAA iris 6 2 64 RER 6 2 6 5 MICHO CSO knee SEEREN 6 2 6 6 Pressure Gaus
15. T In S deL le ALLE Tan 65 fa JA Er e ft x IS a 408 D z7 Fa 5 A ME E IBNP 2895 Cp F z 2 Le END END END vers I veraa b caz vaar WANA BEBS vers a 2412 vecs E E BNF B S Ka ya 193 1 car A GND oa Lon sn 4 Es DONF DBES L er L 7 eL 5 DS u a t m h a g VECS vzar UA TAH a am poo Plug et g s a Fret eff E P als sun fr N slits Lita lle sie Bee Dok m al 2 a P3 REH 27 af A a you wwa ve TAB 3SH END KA DE 40 so ie Bu ma 22 HA 2 maz st laa 3y Ju ae y ka Ei Haw By careen BTEP CLK 2 Ex Tyan nea Ey r a P Jar REF 22 A haa 2 leer ENABLEZ mi HE mere me L x MB 2 JE ar a7 He a lern la vogaa near u bad pa WE 22 t 1a ER e SKE BEDS be P Lop 2 2 sun uno emma 1 1 1 1 1 LT Te E gt P E P KI pla LES mi wl au Vb 5 SS ER HS G Van el La e p Se BETAL Tes TAR TA TALVC42454DB 3 Im Sr del IE SLIESLIE SE VP Da u a la cara a sot S H IBHF B805 y af a sr Mrz 3 K ER ch END chp END END DESCRIPTION METRON lagu ALTH Is Motor drivers NAME HZBBMDII DRAW ND H2BB 20 14B8 12 DATE AM Elektronikk AS 19 03 2002 Box 55 Loirdal REY 1488 OSLO Norway PAGE PPU SELE mm DDUT VER
16. T KTM u Life tu lu ku SND monr ases f f fs fa TE VGC3 3 d KEE EU EL ET A e Le Lie Lie Lis GNP E TE TE TE TE A a JF EoJE JE JE Se arc ukata m Di az 3 je KOL Da D gt Gr KOL2 Da 5 5 ja kata D a 3 L P ukata Ds 7 r 4 71 DE EN ag D STRE D7 D 12 pee Bg al Dal gr 1 BND 0 ODE F vegan E era Ei et opee vera 4 a sin pa He IE El m Di ER 3 ja EZ Da DN E Gr RT 23 5 E a F EES LE D5 7 Le ja A he DE DN a a CETTT D7 5 D Sum D or 1 SEN pl wO DE vera F Y czas ONF asas shea 2 vera GND a ne Zen om LEDO m DI 2 3 ja LCDI DE EN D LCD2 D 5 8 a Lens Be EM 3 D LCDA DS 7 Ka Lens DE EN a KE LEDS Beda D gr pa a LED Ml pk PCA 1 ud ne PCA 2 en E rra Moras ERT rr eh out gege se 12 2805 GC BCE 78 oreo Ze 808475 ia E Ara cae wos oa f we So D a g AR S IBK BENS F Dan Se 5 5 ya appes r Dt 5 5 gy Ze kj a E zs EN An 742 ELI7 2ISURG DB EN a x UP D7 aoe Sae ht gt DOWN DESCRIPTION 1 il cx METRON lagu AUTH VIS END wl ae Digital outputs NAME HZBBMDII H DAAW NO H2BB 20 17B 12 TATE 1 B3 2B 2 Pet AM Elektronikk AS Box 55 Leirdal REV PAGE Sor i 1288 OSLO Norway veraa Ka
17. The numeric and alphanumeric keys are used to enter parameters and for setups 6 3 This page intentionally left blank Appendix A DIAGRAMS Processor Board Schematic Diagram 1 CPU ssesssssssssesseressseeeessreressesersesresresersessersessreressesees A 2 Processor Board Schematic Diagram 2 sseessesessseeessseseeseesessesresresersessteressesresresetsteseenessreressesees A 3 Processor Board Schematic Diagram 3 eeeseseesseeesssesseseesessesrtsresersessteressesresreseestssersessreressesees A 4 Processor Board Schematic Diagram 4 eessesessseessseserseesessestsresersessteressesresreseestsseesesseeressesees A 5 Processor Board Schematic Diagram 5 sesssesessseessesseseesessesresresersessteressestesresetstsseesessreressesees A 6 Processor Board Schematic Diagram 6 ccccecccsseesseesseseceseeeseeeeceeeceecesecesecesecaeceaeceaeeeeeeeenes A 7 Processor Board Schematic Diagram 7 unseenseensenssensennsennsnnnennnnennnnnnnnnennnn nennen nennen A 8 Processor Board Schematic Diagram 8 nennen nennen A 9 Processor Board Schematic Diagram 9 ss A 10 Processor Board Schematic Diagram 10 essssesssseesssesssreesssessrseesersessteresstsresreseeseeseenesseseessee A 11 Processor Board Schematic Diagram 11 essssesseseesssesesseeeessestseseesrssteressesrtsreserseeseenessreeesse A 12 DIL 2BP
18. a minimum volume variation of less than one microlitre in a range of 0 10 milliliter per hour ml hr to 1000 0 ml hr Flow measurements are taken every 30 seconds so that the measurements are independent of the infusion pump s flow rate Test results shown in the lagu s LCD display can be printed out directly or transferred to a PC via the ansur lagu test automation software ansur lets you design test protocols remotely control the lagu and store the test results 1 Flow Rate Flow Range 0 10 ml hr 1000 0 ml hr Min volume detection 0 18 ul Display resolution 0 001 ml hr 2 Time Interval to Achieve Accuracy of Reading It should be noted that the following accuracies are theoretical values based on the minimum volume detection and other capabilities of the unit During the actual calibration and checkout of each lagu unit the accuracy is verified to a 2 tolerance 1000 ml hr 100 ml hr 10 ml hr 0 5 0 6 sec 0 5 6 sec 0 5 52 sec 1 0 0 3 sec 10 3 sec 1 0 26 sec 1 5 0 2 sec 1 5 2sec 1 5 18 sec 1 1 1 3 General Information 1 2 Pressure Generation Range Accuracy 200 to 200 mmHg 201 to 600 mmHg Occlusion Alarm Test Measurement Range Accuracy 400 to 500 mmHg 501 to 1500 mmHg Minimum Input Pressure Bolus Test Accuracy 200 to 600 mmHg 10 mmHg 20 mmHg 400 to 1500 mmHg 10 mmHg 2 of reading 2500 mmHg 20 ul Temperature Requirem
19. ations to determine its index The index value is how the lagu knows the be ginning and end of the uptake 1 Gi E Attach a 20cm tubs to the inlet and occlude the end Access the calibration menu Press MORE F1 Press INDEX F3 to start the process Wait for completion 5 7 Testing Flow Rate Accuracy 1 Set lagu to do a Flow Measurement with a set flow rate Flow Set of 100 ml hr a back pressure setting Press Set of 0 mmHg and a sampling interval dT of 30 seconds Connect infusion set of a calibrated infusion pump to the lagu inlet Note Metron recommends the use of distilled water for calibration tests Prime the lagu e Turn infusion pump ON and set flow rate at 250 ml hr e Select PRIME F1 from the lagu menu e Select GO BACK when all air is cleared from the drain line Set infusion pump to 100 ml hr Press START from the lagu Flow Measurement menu 5 3 6 Run test at each of the below settings for at least 15 minutes and check that deviations are within tolerance limits Flow Rate Max deviation Volume Max deviation 1 ml Hr 0 05 ml Hr 1 ml 0 05 ml 10 ml Hr 0 5 ml Hr 10 ml 20 5 ml 100 ml Hr 5 ml Hr 100 ml 5 ml 1000 ml Hr 50 ml Hr 1000 ml 50 ml 5 8 Factory Flow System Calibration This procedure is a gravimetric calibration and is the same procedure used in the factory to adjust the lagu It is assumed that you have already performed the pressu
20. between your computers serial port and the COM2 port on the lagu 10 Downloading the new firmware from our website will give you a self extracting zipped file set named VX XX exe Where X XX is the firmware version number 11 Run this executable file and then follow the instructions in the FW Upload txt file 5 4 Voltage Control and Adjustment 1 Switch on the main voltage and measure the following voltages for the following test points using the DMM Test point gt Measured Nominal Tolerance GND Value Value 24 VDC 5 5 VDC 2 3 3 VDC 2 5 0 VDC 2 5 0 VDC 0 5V 1 5V 22 VDC 5 5 Pressure Calibration 1 Completely drain the lagu of water by using the DRAIN feature 2 Connect an occluded piece of tubing to the outlet ofthe pump channel that you are testing 3 Connect pressure generator and pressure gauge to the Inlet and start calibration of the pressure gauge Access the calibration menu Set pressure to 0 mmHg and press F3 Set pressure to 500 mmHg and press F4 SG at e The pressure gauge is now calibrated 5 2 5 6 Index Calibration Turn the power off then back on after 5 sec Check that the lagu is within specifications at 400 0 and 1500 mmHg pressure EVER AMEL TE 400 mmHg 10 mmHg 0 mmHg 10 mmHg 1500 mmHg 30 mmHg To ensure an accurate regulation perform a calibration of the index This will cause the pump to go through 5 to 20 complete rot
21. dal REY 1888 OSLO Nor wey PAGE 40F 1 VS gar JA E can7 vs IBENF DEBE EES a 2402 2 m nu aens ds 8 1 5 DH o m D J Ea SL ae ba sk EA Fo q n t sit ut gt vaar STESTEST END E F E H A 3 a pe r Ste rie Sc E H abs END e e z feel E ER A leden pices ce Les LE GET KE uann 4 E A VEE VE va 84254 AB Two 2 E 4 an an Buda D HAT ri 2a 5 HE d we op a 5 ES DE D x a VEDEN e STEP CLE 1 A Fane sra Et T E RESET D I amp Joe 5 2 DEA x A EET 5 3 vm ER BLET e A u CARB malle a wi d lg AT ar s r m h en i ls x HE E nazo or tla tr r PM ton 2 8 ang eens GLA eu zue Dan 1 1 d i 1 A A a a I pefe p g Part dt Lo fe FA ke Ae usar El S El se e El SR E Boss ache Le LAG H 7aLvCaz45ADE am S
22. dently from ansur in the Manual test mode Results are shown on the PC screen during testing and the user is prompted to set the tested equipment accordingly At the conclusion of tests the user may print a report store the test and results on disk or both Combinations of tests can be created and stored as Test Sequences The program maintains a library of these sequences In this way you can store and retrieve sequences that are appropriate for each infusion device being tested at your facility Sequences can then be used independently or can be attached to a checklist written procedure and equipment data in the form of a test Protocol The equipment data can be entered manually into the protocol or it may be retrieved by ansur from a database program or other equipment files Protocols can be created easily for each infusion pump in your inventory and stored for use Test protocols with results can be printed or stored on disk and the results of testing can be sent back to the equipment database to close a work order and update the service history 2 3 This page intentionally left blank 3 Operating lagu This chapter explains the operating controls switches and menus of the lagu details how to use them in testing and provides instructions for printing reports and operator maintenance 3 1 Control Switches and Connections 4 5 6 Selec Front Panel 3 Key Pad Function Keys LCD Display
23. e by averaging the instant flow rates Detecting unexpected flow changes requires detection of tiny infusion volumes as flow measurements may only be calculated every time the defined volume is filled up The ability to detect small infusion volume requires that measurements be made frequently hence a high flow sampling rate The ability to detect only larger infusion volumes decreases the sampling rate as well as the ability to accurately detect flow changes International standards prescribe flow sampling to be done every thirty seconds for all flow rates to ensure a steady rate of infusion from all types of infusion devices To fulfill this requirement minimum volume detection of the measuring device Is critical Example To test an infusion pump for unexpected flow changes at a flow rate of 10 ml hr with an accuracy of 2 the following minimum flow detection is needed Expected flow 10 ml hr 166 7 pl pr minute divide by 60 83 3 ul pr 30 sec divide by 2 2 of expected flow 83 3 ul pr 30 sec x 2 1 67 ul pr 30 sec A volume detection of 1 67 ul is required to detect a 2 unexpected sudden flow change from an expected flow rate of 10 ml hr within 30 seconds The minimum volume detection of lagu is 0 18 ul That means that less than 1 ul is needed for lagu to detect any sudden flow change between 0 10 ml hr and 1000 0 ml hr lagu performs flow samplings every second for all flow rates 4 1 4 2 Test P
24. en sn een Eee Best desi 6 2 6 7 Pump NN NO 6 2 6 8 Stepper Motor Drivers sise 6 3 6 9 Control Panel aaa 6 3 6 10 Component Parts sisi pence cas cacescevindeedacediatiedtadessacdncevandies 6 3 Appendix A Schem ties AA A A 1 Manual Revision Record This record page is for recording revisions to your lagu User amp Service Manual that have been published by METRON AS or its authorized representatives We recommend that only the management or facility representative authorized to process changes and revisions to publications e make the pen changes or insert the revised pages e ensure that obsolete pages are withdrawn and either disposed of immediately or marked as superseded and placed in a superseded document file and e enter the information below reflecting that the revisions have been entered Rev No Date Entered Reason Signature of Person Entering Change p en vi This page intentionally left blank 1 1 lagu Features 1 2 Specifications 1 Introduction This chapter describes the Metron s lagu Infusion Pump Tester s features and specifications METRON s lagu Infusion Pump Tester is a precision instrument designed for use by trained service technicians for testing all types of infusion pumps according to International Electro technical Commission IEC Draft Standard 62 D and IEC 601 2 24 Tests include e volumetric tests e bolus tests e occlusion alarm tests lagu is capable of detecting
25. ent 1 display will appear Mean Flow XXXX X ml h XXXX X Cum Volume XXX XX ml Time Left XX XX XX hh mm ss MORE START PRINT MAIN MENU PumpX AAAA The following parameters are displayed Mean Flow The flow of the liquid volume in infusion pump every second displayed in ml h and Cum Volume The cumulative volume from start of the test Time Left The remaining time before the test is finish e Press STOP F2 to return to the Flow measurement setup e Press MORE F1 and the Flow Measurement 2 display will appear Inst Flow XXXX gt XXX X gt XXXX Inst Flow XXXX gt XXX X gt XXXX ml h Prsr XXXX mmHg dT 30 s MORE STOP AAAA The following parameters are displayed Inst Flow Instantaneous Flow shows max value gt mean value gt minimum value in Inst Flow Instantaneous Flow shows max value gt mean value gt minimum value in ml h Prsr The pressure in the connection tube e Press STOP F2 to return to the previous display e Press MORE Fl to return to the Flow Measurement Setup 3 9 3 4 Printing Test Reports 3 10 Hard copy printouts of test results can be made ifa printer is connected to the lagu See paragraph 2 2 for connecting the printer To obtain a printout of the test select PRINT F3 at the completion of the test As can be seen by the following examples the printouts contain e lagu unit operator and establishment identification e Te
26. ent connection is as shown in the typical setup below For direct communication to a driver free DOS compatible printer attach the printer cable to the 25 pin outlet port on the lagu Printer METR N aaps METRON zue 4 4 VERSION OK GATE Eier Kal Dome z OB om If ansur lagu is being used attach an RS 232 null modem data transfer configured cable to the 9 pin D sub COM2 outlet port located at the rear of the lagu Do not attach the printer cable to the lagu See below However if you are not using ansur lagu and are sending directly to a printer for printouts attach the printer cable to the 25 pin outlet port Printer METRSN aaps METRON is q a VERSION x GATE DOIMMIVVYY Ka Drain 9 One Main On Off Switch lagu should remain off for at least 5 seconds before switching on again in order to allow the test circuits to discharge fully 2 4 ansur lagu NOTE ansur lagu has its own user manual which contains all the information concerning the program If you order a demonstration version of the program you also re ceive the manual ansur lagu is a front end test automation and presentation tool for METRON s lagu Infusion Pump Tester It allows you to conduct the same tests but by remote control via an IBM compatible PC XT with MS Windows Version 98 or later Each of the lagu tests can be run indepen
27. ents 15 C to 35 C when operating 1 C to 50 C in storage do not let freeze Display Type Alphanumeric format Display control Data Input Output 2 Power LCD graphic display 4 lines 40 characters 7 function keys and a keypad Parallel printer port 1 Bi directional RS 232C 2 for Computer control From 110 VAC to 240 VAC 47 63 Hz Mechanical Specifications Housing Height Width Depth Weight Printer Port Standard Accessories Metal case 13 5 cm 5 31 in 23 5 cm 9 25 in 24 5 cm 9 65 in 4 30 kg 9 48 Ibs Centronics Interface lagu User and Service Manual P N 15035 Additional Accessories Carrying case lagu P N 15100 ansur Plug In lagu P N 15200 ansur Plug In lagu DEMO P N 15201 ansur Plug In lagu User Manual P N 15205 Storage Store in the carrying case in dry surroundings within the temperature range specified There are no other storage requirements Periodic Inspection The unit should be calibrated every 12 months 1 3 2 1 Receipt Inspection and Return 2 Installation This chapter explains unpacking receipt inspection and claims and the general procedures for lagu setup 1 Inspect the outer box for damage 2 Carefully unpack all items from the box and check to see that you have the following items lagu Infusion Pump Tester PN 15000 or PN 15500 lagu User and Service Manual P N 15035 3 If you note physical damage
28. esigned METRON will for a period oftwelve 12 months from date of purchase replace or repair any defective system ifthe fault is due to a manufacturing defect In no event will METRON or its local representatives be liable for direct indirect special incidental or consequential damages arising out of the use of or inability to use the lagu Infusion Pump Tester even if advised of the possibility of such damages METRON or its local representatives are not responsible for any costs loss of profits loss of data or claims by third parties due to use of or inability to use the lagu Infusion Pump Tester Neither METRON nor its local representatives will accept nor be bound by any other form of guarantee concerning the lagu Infusion Pump Tester other than this guarantee Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Caution The QA IDS should be operated with de mineralized distilled water only Use of other fluids such as but not limited to saline or glucose solutions may leave crystalline deposits in the pump system that may damage the unit Use of fluids other than de mineralized distilled water will void the units warranty ii Table of Contents e Ea ODUCHON ose cccscscesnssesvescssecseorsecvsseseocesnsossessesvscsasosensuasenessnsseestenseocteccsesteorecssccssessecuscsteacssesesessoseseee 1 1 1 1 A ere ekegren 1 1 1 2 SPECIHCAHO
29. hohr anm sal ad p E sd Zu Diag GT ve po 5 eS ea 7 p 3 cua I m F Tai a E FALVEIBBAD Sup maz B chp TE den AE vers a JET paS F S Van i g zika E t 3 SIB ve y E YEG es pub SEY ser mr D F FESET F Vd TL u M ER asc am xian 153 E a H am ja FO STE SBT 1205 los ver a glass Sec xa ale asp 5 H BLE47B E sl A EDA tena vrede 2 E SDA END E pA AZKTBBHT KA Ge ka an sc sod I La END a Forassat Az an CONTROL BUS END 24258 5M ven TESCAIFTION TOON la en AUTH VIS E cru END NAME HZ MD DRAW NO H248 29 118B 12 AM Elektronikk AS DATE 19 43 2002 Box 55 Leirdal REY 1286 OSLO Norway PAGE 2 OF Il ADAESS BUS vera versa rs vgga a L ais ske DATA BUS ST STE 45 7 ja AE GND ME ya END 75 m a za Al di i W i wo P E mo mn tll op 21 hs Dal ee i Fl rn til pr fo JE 45 pa ya e a po Az n S DA L ku par al e biz EI in pa A pt Ms 3 A pao Al gg in CONTROL BUS E Ve el yr ke SS ge Ja l gle ap E pan mm E er vogs a File vera 7 GND BND 27 s uzee TE28F 1502 ann END vecaa as 5 a El E B et ale ives Vops a 4 5 2 B a E Air jaa H END ME v vm m aa Mal F mm jo r m ia a ar f ae Pp a A NIE 5 mm tl nz i met dE se fa LE pol ER pg l L i si 2 ES JA 12 paa a md ui 5 Ke 53 Sp e
30. is window offers the following functions Press Occlusion Test F5 to go to the Occlusion Test Setup Screen See paragraph 3 4 5 below Press Flow Measurement F6 to go to the Flow Measurement Test Setup Screen See paragraph 3 4 6 below Press Equipment Code F7 to record the code or name of the device under test Press Enter 1 to store PRIME F1 When PRIME F1 is pressed the following display will appear Prime system Connect the infusion pump and prime the system until air in the drain tube disappears GO BACK PumpX Press GO BACK F2 to return to the main menu SETUP F3 This function is used for entering general information in connection with the test Three main displays are shown below SYSTEM SETUP Operator sane Establishment N MORE MAIN MENU PumpX AAAA e Press Operator F6 to record the operator s name or initials e Press Establishment F5 to record the establishment e Press MAIN MENU F4 to return to the main menu e Press MORE F1 and the following display will appear Serial no Reference unit mmHg Alarm After Test No MORE GO BACK AAAA e Press Serial no F7 to record the serial number of the lagu being used e Press Reference Unit F6 to select the reference unit as follows mmHg mBar kg cm inH20 cmH20 kPa inHg PSI e Press Alarm After Test F5 and select Yes or No e Press GO BACK F2 to return to the previous display e Press
31. isplay max time gt elapsed time gt mean time in minutes seconds Bolus The volume expansion within the tube when the infusion pump alarm activates Measurement results display max bolus gt last executed calculation after STOP is pressed gt mean bolus in milliliters Note Maximum 4 4 Infusion Flow Rate and Volume Testing bolus volume to be measured with a standard lagu is about 1 7 milliliters 6 A new measurement in a series Is initiated by just pressing START F2 to start test According to the IEC an occlusion test should be run with different settings of flow rate and if the pump has a programmable occlusion pressure alarm different alarm settings are recommended Press Flow measurement F6 in from the Main Menu and the display will show the Flow Measurement Setup 1 Menu Flow set XXXX X ml h Press Set XXXX mmHg dT g XX s ee MORE START PRINT MAIN MENU PumpX AAAA The following parameters are displayed Flow Set This value is the preset value of the infusion pump All error calculations of the flow measurement are related to this value If the Flow Set value is not entered correctly this may cause a poor presentation with incorrect overall errors Press Set This function gives the possibility to enter positive or negative backpressure into the system Operation range is from 200 to 600 mmHg dT Interrogation time or time between two measurements Average value during the
32. lagu User 8 Service Manual lagu Infusion Pump Tester METKON HO P N 15035 V 1 49 Copyright 2003 by METRON All rights reserved METRON http www metron biomed com USA FRANCE GERMANY NORWAY 1345 Monroe NW Suite 255 30 rue Paul Claudel R merstrasse 22 Vegamot 8 Grand Rapids MI 49505 F 91000 Evry D 63741 Aschaffenburg N 7048 Trondheim Phone 1 888 863 8766 Phone 33 1 6078 8899 Phone 49 6021 447 9807 Phone 47 7395 4700 Fax 1 616 454 3350 Fax 33 160786839 Fax 49 6021 447 9808 Fax 47 7395 4701 E mail support metron com E mail info metron fr E mail proteges t online de E mail support metron no Disclaimer METRON provides this publication as is without warranty of any kind either express or implied including but not limited to the implied warranties of merchantability or fitness for any particular purpose Further METRON reserves the right to revise this publication and to make changes from time to time to the content hereof without obligation to METRON or its local representatives to notify any person of such revision or changes Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Limited Warranty METRON warrants that the lagu Infusion Pump Tester will substantially conform to published specifications and to the documentation provided that it is used for the purpose for which it was d
33. mments 1 81 1244 1 88 1251 1 78 1217 1 82 1237 40 Date Time Signature xx xx xxxx The tested equipment and comments portions enable the operator to manually enter appropriate remarks 3 Presentation of Measuring Data Instant Flow Maximum Flow Minimum Flow Mean flow Cumulative Volume Measured Pressure Elapsed Time Time Left Delay Time 4 mmHg 1 cmH20 1 3 mBar 0 013 kPa 0 13 Flow rate measured during the last interrogation Max flow detected during one interrogation period Min flow detected during one interrogation period Mean flow from start of test till elapsed time Accumulated or delivered volume during the test Measured pressure in the flowline Elapsed time from start of test Time left of a preprogrammed test sequence Delay for calculation of measuring values for a test Scaling Conversion from mmHg to Selected Pressure Unit kg cm2 0 0013 inHg 0 03937 inH20 0 5118 PSI 0 01885 3 5 Operator Maintenance Draining the lagu To ensure proper functioning and reduce the chance of malfunction the lagu should be drained e Daily after use e Prior to storage e Prior to being transported To drain the lagu e Disconnect the infusion set from the Inlet e Press DRAIN F2 in the Main Menu The following display will appear Drain system Disconnect the infusion pump and drain the system until liquid in the drain tube disappears GO BACK AAAA
34. nfusion pump 1 Prime the lagu as per paragraph 4 2 2 above 2 Press Occlusion Test F5 in the Main Menu and the following display will appear 4 3 4 4 Flow set XXXX X ml h Alarm prsr XXXX mmHg Pump type Standard fre MORE START PRINT MAIN MENU PumpX ZX ZX AN AN Press Flow Set F7 to select an intermediate flow rate on the infusion device Press Alarm Prsr F6 to enter a preset pump value on pumps having programmable occlusion alarm settings Start the infusion and simultaneously press START F2 to start the Occlusion Test and the following display will appear Pressure XXXX gt XXXX XXXX Time 1 XX XX gt XX XX Bolus 01 XXX XX gt XXX XX XXX XX GO BACK STOP PumpX AAAA During the test the pressure Prsr in the administration set and elapsed time will be displayed When the Occlusion Alarm on the infusion pump is activated press STOP F2 to stop the test and the following display will appear Pressure XXXX gt XXXX XXXX Time Lo XX XX gt XX XX Bolus 01 XXX XX gt XXX XX XXX XX GO BACK START The following parameters will then be displayed Prsr The pressure in the connction tube Measurement results display max value gt instantaneous measured value gt mean value in mmHg Note For multiple measurements max measured value gt last measured value gt mean value are displayed Time The time from test start until alarm activation Measurement results d
35. op three lines are used for entry of testing parameters by the operator and for messages and test status and results by the lagu These are controlled by the F5 F6 and F7 keys located to the right of the display These keys are operational only when you see the leading arrows gt pointing to the keys The bottom line is a menu bar controlled by function keys Fl through F4 directly below the display It is used for system functions such as PRINT and for inter screen navigation such as MORE and GO BACK Pressing and holding down one of the 11 alphanumeric keys causes it to move automatically from character to character For example pressing the 1 ABC key and holding it down will scroll you automatically through 1 then A B and C Release the key when the desired alphanumeric character appears To delete a letter or number previously entered use the Delete key When all data has been entered on a particular line press the Enter key to exit the line When this is done the data on the line is retained until changed or the device is turned off To avoid loss of data store it in memory 1 Startup Screen The following screens will be displayed in sequence for the first two seconds after the lagu has been switched ON METRON lagu Version XX XX Date DD MM YYYY 3 3 2 Main Menu Equipment Code ward Flow Measurement on Occlusion Test PRIME DRAIN SETUP 3 4 AAAA Th
36. or if the unit fails to function according to specification inform the supplier immediately When METRON AS or the company s representative is informed measures will be taken to either repair the unit or dispatch a replacement The customer will not have to wait for a claim to be investigated by the supplier The customer should place a new purchase order to ensure delivery 4 When returning an instrument to METRON AS or the company representative fill out the address label describe what is wrong with the instrument and provide the model and serial numbers If possible use the original packaging material for return shipping Otherwise repack the unit using areinforced cardboard box strong enough to carry the weight of the unit at least 5 cm of shock absorbing material around the unit nonabrasive dust free material for the other parts Repack the unit in a manner to ensure that it cannot shift in the box during shipment METRON s product warranty is on page ii of this manual The warranty does not cover freight charges C O D will not be accepted without authorization from METRON A S or its representative 2 1 2 2 Setup NOTE Some RS 232C cables are missing the connection between the seventh and the eighth wires in the cable The cable may still be called NULL modem but it will not work with the lagu Refer to the ansur lagu Users Manual for more information 2 3 Power 2 2 Equipm
37. rall errors Press Set This function enables you to enter positive or negative backpressure into the system Operation range is from 200 to 600 mmHg dT Interrogation time or time between two measurements Average value during the test interval is displayed Recommended dT from IEC is 30 sec and this is the minimum value to be selected on the lagu Maximum dT is 600 sec or 10 minutes Default value is 30 sec e Press Flow Set F7 to set the preset value of the infusion pump e Press Press Set F6 to set the relevant or backpressure into the system e Press dT F5 to set the interrogation time or time between two measurements e Press PR HDR F3 to print a header e Press MAIN MENU F4 to return to the Main Menu e Press MORE F1 and the following screen will appear Test Time XX XX XX mmihhiss gt Delay Time XX XX XX mmihhiss gt MORE START MAIN MENU PumpX AAAA The following parameters are displayed Test Time This is the preset time for a test Maximum testing time is 24 hours Default value is 1 hour Delay Time This is the delay before the first measuring e Press Test Time F7 to set the actual time of the test 3 8 e Press Delay Time F6 to set the delay before the first measurement e Press MORE F1 to return to the previous display e Press MAIN MENU F4 to return to the Main Menu e Press START F2 to start flow measurement and the Flow Measurem
38. re 1 0 an ga 4 Is J 48 MB ja An 41 De an 42 4 BL is an 43 PET END END mere LEDE BO 7 LEDI k LER 5 LEDE 189 a gt LED amp Jen a Lena 15043 7 LEDS seng LEDS sen G LED J P warmen e AER 19 J5 1 8 1160 3 ES 15 me werd 11604 g a u AER 12 1a ges z 188 END wees 58 1 Wenn ES vzar A wanr enas gt 1158 2 e x i 2 V24P TEBTP a RES RISD 22R 0805 vor a a A e EUS 5 var reste ep gene PISA TACO RIS 220 0805 vers e 5 END BEND ha vers reste de een ok ru AGB El msz 22R 0805 vogaa 2 n vera TESTA o y j 2 RSJ 220 0605 POWER END ams z DESCRIPTION Risa 220 0805 N Pet METRON lagu AUTH VIE Mica 2P r Infusion Pump Tester iua EE AND NAME H2DDMDI VSN TESTF a En a DRAW ND H2B8 20 1B88 12 ren TATE 18 03 2002 W22NTES TE AM Elektronikk AS Vas Box 55 Lairdal rev PAGE Tor tt AAB OSLO Norway
39. re and index calibration steps above Setup Temperature 23C 3C Power on for a minimum of 20 minutes prior to testing Shielded micro balance Container with a little water with some paraffin kerosene floating on top to greatly reduce evaporative losses Set the outlet of the flow reference and the inlet of the lagu to the same height Set the outlet ofthe drain tube going into the balance to the same height as the outlet of the lagu 1 Prime the system until there are NO air bubbles visible from the outlet 2 Goto the flow set menu and set the flow rate to 100ml h 3 Set the test time to 30 minutes display reading 00 30 00 4 Set the delay time to 0 display reading 00 00 00 5 4 Set your flow reference to approximately 100ml h Start your flow reference When the flow reaches a steady state press START on the lagu and the ZERO or TARE on the balance at the same time Stop your flow reference the moment the test period ends Record the weight on the balance and the cumulative volume on the lagu Using the conversion of 1g 1ml for the density of water corrected for your environment compare the values If the values are within 2 no adjustment needs to be performed and the other flow values of 10 ml h and 500 ml h may be tested for 10 minute durations If the values are not within 2 the pump volume value needs to be adjusted in the calibration menu in accordance with the following equa
40. reparation WARNING Do not start measuring with the lagu without having liquid in the system as damage to the pump motor may result IMPORTANT Connect a drain tube with a minimum length of 10 centimeters 3 95 inches Do not use lagu without a drain tube Place the collecting vessel at the same level as the lagu METRON recommends sterile distilled water in test use as tap water contains too much oxygen and potentially destructive deposits Remove all air inside the administration set before connecting it to the lagu Air passing through the measuring system will give incorrect readings Do not re circulate the water 1 Set up the test components See below Infusion Container Infusion Delivery Device Set Collecting Container e Connect the infusion pump being tested to the lagu Inlet Port and to an infusion container e Switch the lagu ON The following will be displayed in the LCD display for about two seconds METRON lagu Version XX XX Date DD MM YYYY 4 2 4 3 Occlusion Pressure Bolus Volume Testing CAUTION Prime the unit properly Do not exceed the recom mended maximum prim ing rate of 250 ml hr e Fill the administration set with liquid Metron recommends distilled water The placement of the collection vessel for the infusion liquid is important According to the IEC the output level of the administration set should be at the
41. robalance Test durations may need to be changed based on range resolution and accuracy WARNING HIGH VOLTAGES ARE CAPABLE OF CAUSING DEATH USE EXTREME CAUTION WHEN PERFORMING TESTS AND CALI BRATION USE ONLY INSULATED TOOLS WHEN THE UNIT IS PLUGGED IN AND THE METAL CASE HOUSING IS OFF 1 Remove sides and top metal case housing 2 Set contrast in the character LCD display by adjusting potentiometer R160 located at left of CPU to desired contrast The contrast for the Graphical display is adjusted via software Tf the unit runs an earlier version of the firmware the unit is to be updated with the latest version The latest version can be downloaded from our website www metron biomed com It s important that the firmware is updated before continuing to the calibration procedure The following procedure describes how to upgrade the firmware 1 Turn on the lagu 2 Press SETUP F3 from the Main Menu 3 Press MORE F1 from the System Setup 4 Press the Pump channel 1 button 3 1 5 Press CAL F3 5 1 6 Record the values for Prsr offset and Prsr slope 7 Press MORE F1 and record the value for the pump volume 8 Press Main Menu F4 You are now ready to remove the old firmware and install the new one Please note that the following steps will disable all of the functions of the lagu unless you finish the procedure 9 Connect the RS 232 NULL Modem cable
42. s bp SE ng med zo kr lm me lr we me JP 8 Les fl 2 E 22 op 1 uzi g KBFEBISVIM TF7O E Dn ou p H i z GHD chp DESCRIPTION METRON lagu pode Memor y NAME H7BBMDI DRAW ND H2BB 20 1289 12 TATE AM Elektronikk AS ke Box 55 Leirdal REV 1888 OSLO Nor woy Ds TA 2 z ST 4238 373 N saga a 0554 5 al ssen a af sinia or 1883 1594 5 1334 5 T 2 A pr sedis er I PCA 2 pa END BE N mo op a aa ee Jaas a D END Tue 1 M I Larei 2 J BS STEP ELK I Bh STEP CLK 1 RE 1 5 EXABLET s EMABLET a a 1 MOTOR DRIVERS po Mil Koch Mil END O A 15 2 J BE MA 2 REF 2 NA HEES J DE et S STEP ELK 2 A STEF CLK 2 r J DE ENABLE 4 ENABLEZ JOBE RE 2 5 ME e 1e 2 J BE MI a M e RESET A RESET a a A VEI Elg MXSAPIL L JE I Jagi vg EF E Ei El MAIL M veg a A E a 1842 EA E RAAI Janz INDERET Ce 3 INTE se 4 EE PRESSURE pour x4 nour MEASUREMENT MBP we Ka a uana S mz ssa at D sik a E mL e a BT if i i Se 15 eos z aa END Demi 5 GND a 8 AGND DESCRIPTION METRON lagu AUTH VIS lagu specific parts NAME H2BBMD 1 DRAW ND H2BB 29 1309 12 AM Elektronikk AB TATE 18 03 2002 Box 55 Leir
43. same level as the input level to the infusion pump during measurements If not a positive or negative backpressure will be introduced in the flow line depending on whether the output is at a higher or lower level than the input If the difference of the two levels is large this may have some influence on the measuring results 2 Prime the lagu Before starting the measurements the internal volume of the lagu has to be filled with liquid e Connect the administration set to the inlet of the lagu e Press PRIME F1 in the Main menu and the following display will appear Prime system Connect the infusion pump and prime the system until air in the drain tube disappears GO BACK e Start the infusion pump with a flow rate of up to 250 ml h Keep the lagu working until there is no more air in the tubes Timeout is max 10 minutes e Press GO BACK F1 to return to the main menu To protect the patient an infusion device should include an occlusion pressure alarm This alarm should activate if the pressure inside the administration set exceeds preset levels Since an occlusion with built up pressure also distends the administration line an excess volume of liquid is stored in the line This is the Bolus volume which is a discrete quantity of liquid delivered in a short time and is not intended to form a part of the continuous flow output Such uncontrolled volume may also be a risk to the patient and must be measured for the i
44. sted equipment identification e Test setup data and detailed results e Test summary e Comments 1 Example Printout of a Flow Measurement Test METRON QA IDS Infusion pump tester Ver xx xx QA IDS Ser No E Operator y EL ES Establishment METRON EQUIPMENT INFORMATION Equipment Code Serial No Status Group Manufacturer Type Model Location SETUP DATA FLOW MEASUREMENT Flow set 10 0 ml h Test Time Press set 0 mmHg Delay Time 30 s Pressure Cum Volume Inst Flow Mean Flow mmHg ml ml h ml h 8 saa ek La 0 25 7 47 25 ST U 0 10 95 9 47 gt I 1 0 252 4 87 S 0 0 0 03 0 0 Be 0 03 0 7 0 7 0 51 25 A 3 0 EI 23 0 0 0 56 5 69 6 Om eu e Lat 6 ER 16 3 3 4 m TEST SUMMARY Mean Flow Max Peak Flow Min Peak Flow Cum Volum d Measurement time Comments Date Time Signature xx xx xxxx 2 Example Printout of an Occlusion Test METRON QA IDS Infusion pump tester Ver xx xx QA IDS Ser No t Operator EF Establishment METRON EQUIPMENT INFORMATION Equipment Code Serial No Status Group Manufacturer Type Model Location SETUP DATA OCCLUSION TEST Flow set 100 0 ml h Alarm Pressure Occlusion Alarm Time Test No MM SS 0 mmHg Bolus Alarm Pressure ml mmH Re IO II II III IIS III I EE IIIT RR 81 76 86 SUMMARY of occlusion tests Alarm Time Bolus Alarm Pressure Co
45. ted from V5P using a variable voltage divider R1B26 and an operational amplifier U1B20 U1B20 is also used for temperature measurement The lagu has a pump from Saphierwerk driven by a stepper motor The pump is a rotating piston pump with the pump head and piston in artificial sapphire It pumps 50 ul per revolution The pump has a circuit board with a Hall sensor to provide an index per revolution 6 8 Stepper Motor Drivers 6 9 Control Panel 6 10 Component Parts The index is used to measure the volume pumped The stepper motor is a bipolar type with 200 steps per revolution The stepper motors are run by three circuits from Ericsson The stepper motor driver U 1810 is connected to the CPU and generates the control signal to two driver circuits The stepper motor can run in full and half step mode The driver circuits U1820 and U 1830 have built in temperature protection and pulse width modulation to control the current drawn The motor drivers are supplied with 24V to achieve rapid current increase and good torque Each phase of the motor can be supplied with up to 1 5 A which is regulated by the software independently of the step rate U1840 is used for synchronizing the pulse width modulation to the drivers to prevent high peak values in the current drawn The control panel is made up of a LCD display with 4 x 40 characters and a keypad with 22 push buttons The function buttons control the menu choices shown on the display
46. tion Previous Pump volume Volume reference weight New Pump Volume 13 14 Cumulative_Volume_lagu Change the pump volume to this new value and record on the measuring report Perform this procedure again starting at step I and use a 10 minute test time instead of 30 minutes The test is complete 5 5 6 1 Theory of Operation 6 2 Power Supply 6 Component Functions and Parts This chapter provides a description of the functions of the lagu components and a parts list for cross reference The lagu consists of an independent primary switched power supply a keypad board a processor board a LCD display and an index transmitter mounted on the pump The processor board keypad board and index transmitter are described in diagrams contained in Appendix A One is a Component Location Diagram Another F190 20 2000 10 is a schematic diagram describing the keyboard pressure sensor and pump index F190 20 1N00 10 diagrams the Processor Board Main Part Set F190 20 1000 10 through F190 20 1900 10 are schematic diagrams describing the processor board by function The boards are connected by 2 x 16 conductor flat cables 1 x 3 conductor and 1 x 2 conductor The lagu is an infusion pump tester that runs on 110 230 V AC mains voltage The unit is based on a Motorola microprocessor Controls on the front panel of the unit allow testing of all the functions of an infusion pump lagu performs tests according
47. to IEC Draft Standard 62 D and IEC 601 2 24 Test results which are shown in the lagu LCD display may be printed out on an external printer A serial port RS 232C enables the unit to be controlled from a PC simply by using the ansur lagu software program The program in lagu is stored in RAM with battery backup and can be updated from a PC via the built in serial port The power supply consists of a primary switched unit mounted on the backplane that supplies 24 VDC 2A to the processor board V24P The processor board is equipped with a secondary switched regulator that generates 5 VDC Vcc Via a passive filter this is used as the supply voltage to the measurement amplifier and A D converter V5P A capacitive switched supply generates 5 VDC to the measurement amplifier and A D converter V5N A reference voltage of 4 096 V is generated from V5P which is used for the A D and pressure sensor The supply voltages are monitored by a watchdog and the unit is reset if V24P falls below 20 V The contrast on the display is regulated using R160 The stepper motor drivers are supplied directly from V24P 6 1 6 3 Printer Output 6 4 Serial Port 6 5 Microprocessor 6 6 Pressure Gauge 6 7 Pump 6 2 The lagu has a printer output with a standard 25 pin D sub contact for Centronics interface The drivers are built up with TTL inverters which are run from a register connected to the data bus The inputs are protected against
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49. yed in milliliters per hour ml h and percent Cum Volume The cumulative volume from start of the test Time Left The remaining time before completion of the test e Press STOP F2 to return to the Flow Measurement 1 display e Press MORE F1 and the Flow Measurement 2 display will appear Inst Flow XXXX gt XXX X gt XXXX Inst Flow XXXX gt XXX X gt XXXX ml h Prsr XXXX mmHg dT 30 s GO BACK STOP PumpX The following parameters will then be displayed Inst Flow Instantaneous Flow shows max value gt mean value and minimum value in percent Inst Flow Instantaneous Flow shows max value gt mean value and minimum value in milliliters per hour ml h Prsr Shows pressure in the connection tube e Press STOP F2 to return to the previous display e Press MORE F1 to return to the Flow Measurement Setup 4 7 This page intentionally left blank 5 1 Required Test Equipment 5 2 Adjusting the Display Contrast 5 3 Upgrading Firmware 5 Control and Calibration This chapter explains the lagu maintenance procedures including factory testing and calibration The calibration procedure for 1 and 2 pump units is identical You just need to repeat the relevant portions for each pump your unit contains e Digital multimeter 10 UV resolution 0 1 accuracy e Pressure vacuum generator 400 to 1700 mmHg pressure e Pressure gauge e Infusion pump or flow source e Mic
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