Boehringer Mannheim Diagnostics
Reflotron Operators Manual
Operators Manual
36 Pages
Preview
Page 1
Introduction
1
Installation Principlesof Operation
7
PerformanceCharacteristicsand Specifications
o
Controlsand Display Used for Operation
11
Calibration
IJ
OperatingInstructions Precautions,Limitations,and Hazards
21
Maintenanceand Service
23
TroubleshootingGuide
27
ReflotronProcedureSummary
?1
QualityControl
??
The Reflotroni!L/sesthe principlesof reflectancephotometry and reagentstrip technologyto analyzevariouschemical c o m o o n e n t fso u n d i n b l o o d . T e s ts e l e c t i o np, e r f o r m a n c ea,n d l o t s p e c iifc c a l i b r a t i o na r e d i r e c t e db y a m a g n e t i cs t r i pl o c a t e do n t h e u n d e r s i d eo f e a c h c o m p o n e n t - s p e c i ftiecs ts t r i p .T h e r e a g e n p t a d su t i l i z ew h o l e b l o o d ,s e r u m ,o r p l a s m af o r a n a l y s i so n t h e i n s t r u m e n tw, i t h t h e r e s u l t sa p p e a r i n ga u t o m a t i c a l loyn t h e f l u o r e s c e n c de i s p l a y w i t h i n1 1 / 2 - 3m i n u t e so f i n s e r t i o nd,e p e n d i n g o n t h et e s t . T h i sO p e r a t o r 'M s a n u a lc o n t a i n sa l l o f t h e i n f o r m a t i o n n e c e s s a rtyo o p e r a t ea n d m a i n t a i nt h e R e f l o t r o n . .D o n o t a t t e m p t o c o n n e c to r o p e r a t et h e i n s t r u m e nbt e f o r eb e c o m i n g t h o r o u g h l yf a m i l i a rw i t h t h e i n f o r m a t i o nc o n t a i n e di n t h i s m a n u a l (. S e eF i g u r e1 ) . Figurel, Reflotror@
R e m o v et h e R e fl o t r o n ' f r o m i t s s h i p p i n gc o n t a i n ear n d p l a c ei t . i s u a l l yi n s p e c t h e i n s t r u m e nfto r u p o n a s o l i dw o r k s u r f a c eV p o s s i b l ed a m a g es u s t a i n e d u r i n gs h i p m e n at n d c h e c kt o s e e t h a t t h e f o l l o w i n gi t e m sa r e i n c l u d e di n t h e s h i p p i n g containers: 1 . M a i nC a r t o n 1 Reflotron'"ReflectancePhotometer 1 WarrantyCard 1 R e o l a c e m e nMt a i n F u s e s z.
t ccessoriesCarton
Reflotronr Console ReflotronriPipette32 pL PipetteTips (bagof 50) ReflotrontoCapillaryTube Pipettor R e fl o t r o n ' "3 0 p L C a p i l l a r yT u b e s( T u b eo f 1 0 0 ) R e fl o t r o n € ' - C h e c(kc o n t r o ls t r i p s ) PowerCord 1 Reflotrone'Manual Fuses AssortedRePlacement Carton 2, MainCarton/Accessories Figure
' Location Proper locationis essentialfor reliableperformanceof the The instrumentshould be placedon a solid work Reflotron@. surfacethat meetsthe following installationrequirements:
't.
The environmentaltemperaturemust be between15"C and 32'C (59"F-90.F).
2. The relativehumidity must be lessthan 850/o. The environmentshould be as free as possiblefrom dust, mechanicalvibrations,and electricalinterference.The Reflotron@ should be at least2m (6 1/2 tt.) from any high frequencyor ultrasoundinstruments.Low f requency emitters,such as centrifuges,should also be at least2m away. Do not installthis instrumentnear heat-producing equipmentor in close proximityto incandescentlighting which could causeoverheating. 5. This instrumentrequiresa groundedwall outlet supplying either 100,120,220,or 240VAC, 47-63Hz. The instrumentis factoryset to operateon 120VAC. lf the line voltageis not 120VAC, however,the instrumentsetting can be changed by moving the voltageselectorwheel, located on the rear of the instrument,so that the propersetting can be seen in the window. The followingsettingsshould be used depending upon the line voltage: tinc Volhgr
Voltege SolsctorWhsel
1 0 0 -1 1 5 V 115 - 127V 220 - 235V 235 - 250V (SeeFigure3.) Figure3, Vohaga WhealCover Sclector
f
M
i]
100v 120V 220V 240V
6 . lf the voltageis changed,rememberto changethe main fuse as well. The replacementfusesare packedin the Reflotron@ I n s t r u m e nbt o x . For 100/120V For 220/240Y
0 . 6 3A T f u s e 0.4 AT fuse
For fuse changinginstructions,referto the Maintenanceand Servicesectionof this manual. 7. Mount the Reflotron@ Consoleby looseningthe retaining screwand fitting the consoleinto the slot betweenthe two halvesof the housing.Tightenthe retainingscrewat the b a c ko f t h e i n s t r u m e n t . ( F i g u r e s4 a n d 5 i l l u s t r a t e theReflotron@) Figure 4, Reflotror@, FrontView
Figure5, Reflotron@, BearView
Instrument PowerConnections
'1.
Verifythat the positionof the voltageselectorcorresponds to the line voltagesuppliedby the wall outlet.
2. Ensurethat the instrumentON/OFFswitch is in the OFF position.Plug the femaleend of the three-prongpowercord into the power connectionsocketon the rear of the instrument. 3. Plug the three-prongpowercord into a wall outlet that providesa three-holegroundedconnector.lf the wall outlet will not accepta three-prongpower plug, connect the plug to the outlet through a three-prongto two-prong adapter, and ground the adapter. WARNING:A poor ground may causeelectricalshockto the operatorand/or malfunctionof the instrument.A good ground connectionis alwaysrequired.
The Reflotron@is an electrochemicalreflectancephotometer designedto analyze Reflotron@ reagenttabs for various chemicalsubstancesfound in blood.The unit consistsof a power supply,signalprocessor,digitaldisplay,opticalmodule, and Centronicscomputerinterfaceconnection. ReagentTab Principle The Reflotron@ reagenttabs consistof three basic components:a separationpad,a reagentpad, and a magnetic code. (See Figure6.) The separationpad is constructedso that plasmais separatedfrom whole blood via glassfiber paper. (Serumor plasmamay also be usedas the sample.)The design of the pad forces the separatedplasmato flow to the reagent pad;this is where the chemicalreactiontakes place.The magneticcode, locatedon the undersideof each reagenttab, allowsfor the transferof up to 500 bits of electronicdata.This informationincludestest selection,durationof the preincubationand reactionphases,wavelength,specifications for calculationof the resultfrom the reflectancemeasurement, and factorsfor StandardInternational and Concentrationunits. Figure 6. TestStripConstruction transparentfoil E
materiai
transportmaterial= plasmareservoir
magneticcode
Beflotron@Principle Utilizingthe principlesof reflectancephotometry,the Reflotronc"r measureschromaticchanges of Reflotron(*) reagent padsdue to componentchemistryreactions.The signal processortransmits the associatedvoltage to the display and to the computer interface(if applicable).
PowerSupply The powersupply draws from an input sourceof 100,120,220, or 240VAC to adjust incomingvoltageto an acceptablelevel, therebyprotectingit from chancefluctuation. SignalProcessor The'signalprocessoracceptsvoltagefrom the optical module that voltageto the printer beforeconvertingand,transmiting and computerinterface. DigitalDisplay T h e . d i g i t adli s p l a yi s a f l u o r e s c e n c e1,6 - c h a r a c t e r (alphanumeriu c )n i t u s e dt o r e l a yr e s u l t so, p e r a t i o n a l and error messagesto the operator. messages, OpticalModule T h eo p t i c a m l o d u l e( U , l b r i c hstp h e r e c) o n t a i n st h r e ep u l s a t i n g t h e r e a g e n tp a d o f t h e l i g h t - e m i t t i ndgi o d e sw h i c h i l l u m i n a t e reagenttab. Two detectorscomparethe emittedand reflected light,with light reflectionbeing inverselyproportionalto the concentration of the uhknown in the sample.Increasedlight reflection(lightercolor of the reagenttab) resultsfrom lower concentration of the unknown in the sample.Conversely, decreasedlight reflection(darkercolor of the reagenttab) r e s u l t sf r o m h i g h e rc o n c e n t r a t i o on f t h e u n k n o w ni n t h e sampre. ComputerInterfaceModule Centronics T h i sc o m p u t e ri n t e r f a c e " m o d upl er o v i d e sf o r a c o n n e c t i o n to a computer. from the Reflotron@
1. 0ptical System: Principle:
Measuringthe reflectance,i.e.the diffuse reflectionwith the aid of a n U l b r i c h t s p h e r e( i n t e g r a t i n g sphere),using a referencebeam
Wavelengths:
567 nm, 642 nm, 951 nm
Light source:
L i g h t - e m i t t i n gd i o d e s ( L E D ' s )
Light detectors:
Two photodiodes
Automatic compensation: Measuringrange: 2. Temperature Maintenance: 3 . Resetting for tew Tests:
For the zero pointand changesin current frequency 2.5 - 9oo/odiffuse reflection 37 + 0.1'C This is not necessary, sinceall the data for new testsare encodedin" the magnetic tape at the bottom of the reagenttab.The Reflotron@ does not require the resetting proceduresneeded in other photometric assays.
4. Accuracy Input: ,of
The datareceivedarecheckedfor feasibility.
5. Electronics:
Rockwell 6502 microprocessor 20 k bytes of ROM. Display is I 6 - c h a r a c t e rs e l f - i l l u m i n a t i n q alphanumeric
6. Accuracy:
+ 0.5% of the reflectancewith respect to the true value
7. Precision:
* O.2o/o of the reflectance
8 . Iinearity:
+ 0.05% deviation
9. RequiredEnvironment:
15-32"C (59-90'F),max. relative humidity 85o/o
1 0 . P o w e rS u p p l y :
1 0 0 1 2 0 , 2 2 0 ,a n d 2 4 0 V A C i t o l e r a n c e - r1 0 % ) . 4 7 - 6 3H z
ll
B0 W max
Power Consumption:
1 2 Fu s e s :
M a i n F u s e s 1 0 0 / 1 2 AV A C 0 6 3 4 T 220/240VAC 0 4AT AdditionaF l uses 05 fo r S e r v i c eo n l y O 6 3
AF
1 6
A i
A'
0 315Af' 10
if
13. Dimensions:
l 9 4 c r n ( 7 - 5 / Bi n . ) H e r g i r l 2 9 2 c m ( 1 1 - 1 / 2i n . ) W t d t h 3 4 9 c m ( 1 3 - 3 / 4i n ) D e P t h
1 4 .W e i g h t :
'
1 5 . In t er f a c e :
C e n t r o ni c s
55kg(:12 lbs)
The Reflotron@ is equippedwith a powerswitch,a SI-CON switch,and a temperatureswitch,all locatedon the front of the instrument(SeeFigure4). An understandingof the functionof theseswitchesis importantfor accurateinstrument performance. Power switch -
T u r n s i n s t r u m e npt o w e rO N o r O F F . ( 1= O N , 0 = O F F )
SI-CON switch
Selects for type of unit in which results will be displayed. CON = Conventional (mg/dl, g/dL, U/Ll Sl = Standard Intern a t i o n a lU n i t s ( m m o l / L ,p m o l / L , U / L )
Temperatureswitch -
Can be set at 25,30,or 3ZoC.Results o f e n z y m ed e t e r m i n a t i o nwsi l l b e d i s played for the temperatureat which the switch is set. The Reflotron@ maintainsthe testingtemperatureat 3 7 + 0 . 1 o C . l f t h e r e s u l ti s displayed at one temperatureand anothertemperatureis thenselected, the Reflotron'^automaticallyconverts the result to the new temDerature.
Eachcompon"l,:l::ific
reasent,1g=".o
with rheReflorron e i t"" t test selection ;l;::["':l'ifr3 i :'ln""ti" ""i"'ii ou t i o n l"nir!' selection, ;"rllf 1;'
' ^ gifa# ";iiff ii#tr d[ d ::,,"*:"r[il,* i+ P.':q :'v""ffi ;"J;i'*Ril::-Til{ ;ii!$ii Yil:ie ""
(Usethei"r"i""#'lat theopticafsvs
the.Rerrotronul'c"^u^'^?'?.*i'ni'nliiJry'?ri'.J'.'#11?JJr:tJjJ . i"]r.i#.j.li;;:i:i,X;,nps asis;donotioj.""ir,lJ"in"" Relerence/ ControlSera
JJ;,l3li"*,ns
reference serashouldbe used for quatity
Precinorm' to'
No. 74s1s4 1:,t1?iron@'-catarog
i#[qhi[:{"A':;'"",1;Ftx'l,',#i,l',1?l1iun, .t:,*;:ffi:i"","[,j:1.^l"_ouireexactry 2
mLdistirred or accurare'.".,li. ;'&.",T'lj il:il,.r,i::;fi:iasl lj un.,,.u The valuesfor ther
.i}",;:; :: n::1,: Ili f '3" * "hinthe :ff:,f14-; "; ": gbtlined,and [?ff'^!:l or theassayexcrrols
rueorcalService De
"."1".,1?^t al"t:;;l'JTi;iq Berforron-check strips'pdttmenl
ue'contact our
^ :r,'r:?r'"a : r ;ilTnl;1#hx:tl; Ir';'ry;r**:1: +i i,i$,;?i ,tnthemean varues h { e l t o t r o n ,_" c h e c k
r
t. Weekly,rernove a
rvoiL,;l?#? xi:ff :lilX'::.,ltiprrom the 91ni11er
fi:;:i.L""?l 3#:I:lilH:::nf';XT:: lfj 'i;il J'
2 Cfosethe canister rmmediatelyto protect dust and_niJ;;;;;; the srripsfrom
13
Do not touch the gray areaof the test strip. Do not wipe the calibrationstrip with any solventor cleaningagent.Dirty strips must be discarded. Insertthe calibrationstrip,with no sampleadded,with the brown magnetictapeon the bottom and the gray area pointing towardsthe instrument.Close the sampledoor. During the countdownperiodthe Reflotron@ measuresthe reflectedlight at its threeemissionwavelengths;it then calculatesthe reflectance. o . The three resultsdisplayedon the screenmust fall within
their respectiverangesprintedon the Check canister.lf any valuesare outsidethe specifiedrange,wipe and disinfectthe transporterand heaters(seeMaintenanceand Service s e c t i o no f t h i s m a n u a l )w i t h a m o i s t e n e dc l o t h .A l l o wt o d r y folI 5 minutes.Repeatthe measurementwith a new, unused, dust-free calibrationstrio. 7. lt any valuesare still outsidethe requiredrange,contactour MedicaI Service Department at 1-800-428-467 4.
14
Beforeturningthe Reflotron@ on, makecertainthat the instrumentvoltagesettingcorrespondsto the line voltageat the wall outlet.See Installationsectionof this manualfor voltagesettinginstructions. lf a printeris interfacedwith the Reflotron,o the printershould be switchedon first. 1. When the powercable has been pluggedin, movethe power s w i t c ht o p o s i t i o n1 ( 1 = O N ) . A i l p o s i t i o n so n t h e d i s p l a y light up and then a seriesof zeroesfollows. 2. "REFLOTRON"is disptayed,foilowedby ..WARMING UP 28
0" The instrumenthas a warm-up time which dependsupon the ambienttemperature.
3 . "READY"is displayedafter the warm-uptime expires. 4 . Removea new,unused Reflotroncreagenttab for the test
selected(e.9.GGT, Gtucose,etc.).Closethe canister immediatelyto protectthe remainingtabs from dust and i moisture.NOTE: The canisterof reagenttabs is equipped with a desiccant-containing stopper;this protectsthe reagentcarriersfrom humidity.The expirationdate printed on the labelappliesonly if the stopperis replaced immediatelyafter removinga reagenttab.
Protecl all Reflotron@reagent tabs from all magnetictields; the ma$neticcode on the undersideol the strips may be damaged by magnetic fields. Damagedmagneticcodes are recognizedby the display "CODE ERROR". o.
Each reagenttab is protectedby an aluminumfoil; remove the foil beforeusing the reagenttab.Genllystrip off the loose end of the protective foil (seeFigure7) and discard it. Be carefulnot to bend the reagenttab.
15
Figure7, RemoveProtectiveFoil
fr
, , t€*3, { ,.{i,1
g;&
fl
'/*
ffi a{
r
-'%
.iX-
D o n o t c u t o r a l t e rt h e r e a g e n t a b i n a n y w a y . U s et a b so n l y as providedto ensureaccurateresults. T h e f o l l o w i n gs a m p l e sm a y b e u s e d : c a p i l l a r yw h o l eb l o o d venouswholeblood SETUM
plasma T h e H e m o g l o b i nt e s tm u s t b e r u n w i t h w h o l e b l o o d . The packageinsertsfor the variousReflotron. reagenttabs c o n t a i nd a t a o n s a m p l es t a b i l i t ya n d w h a t a n t i c o a g u l a n t s may be used. Referto the packageinsertsfor test-specific questrons. The Reflotron';Pipettewas developedtor the universaluse , n d e n s u r e st h a t t h e o f u n d i l u t e db l o o d ,s e r u m a , ndplasmaa proper amount of sampleis drawn everytime. The proper a m o u n to f s a m p l ei s 2 8 . 5- 3 ' 1 . 5p L . T h e R e fl o t r o n" P i p e t t e a s p i r a t e s3 2 p L o f s a m p l ea n d d i s p e n s e s2 8 . 5- 3 1 5 p L . U s e p i p e t t et i p s o n l y o n c ep e r t e s t . P l a c ea n e w t i p o n t h e p i p e t t eP . u s ht h e p l u n g e rt o t h e f i r s t s t o p a n d a s p i r a t et h e s a m p l eb y s l o w l yr e l e a s i n gt h e p l u n g e r .H o l d t h e p i p e t t ea t a 4 5 " a n g l ea p p r o x i m a t e l2ym m a b o v et h e r e d m e s h .P u s ht h e p l u n g e rt h r o u g ht o t h e s e c o n d s t o p t o d e l i v e rt h e s a m p l eD . o n o t t o u c h t h e r e d m e s hw i t h t h e p i p e t t et i p . 1 0 W i t h i n 1 5 s e c o n d so f a d d i n gs a m p l e i, n s e r tt h e r e a g e n t a b i n t o t h e t r a n s p o r t e rw, i t h t h e m a g n e t i cs i d e d o w n ,a n d l o c k i n t o p o s i t i o n .H o l d t h e s t r i ph o r i z o n t a l l ay n d l e t i t s l i d ei n t o t h e I n s t r u m e not n t h e t r a n s p o r t e T r .h e f o l l o w i n gm e s s a g e w i l l a p p e a r ." C L O S ED O O R " . I O
, a k es u r et h a t t h e m a g n e t i c N O T E : A s t h e s t r i p i s i n s e r t e dm code is on the bottom. lf the displaydoes not show "CLOSE , a k i n gs u r et h a t D O O R " ,r e m o v et h e t e s t s t r i pa n d r e i n s e r tm i t l o c k si n t o p l a c e ." C L O S ED O O R "w i l l a p p e a ro n t h e d i s p l a yC . l o s et h e s a m p l ed o o r .( S e eF i g u r e9 . ) Figure 8, Applying Sample
TestStrip Figure9, lnserting
1 1 T h e a n a l y s i sb e g i n s i m m e d i a t e l yu p o n c l o s i n g o f t h e s a m p l e d o o r . T h e t e s t n a m e ( e . 9 . G G T , G L U , e t c ) a p p e a r so n t h e d i s p l a y ,f o l l o w e d b y t h e n u m b e r o f s e c o n d s l e f t i n t h e analysis
17
1 2 . T h e r e s u l ti s d i s p l a y e dw i t h t h e t e s t n a m ea n d t h e u n i t ,e . g ." G L U 1 2 8m g / d L " .W i t he n z y m e st h e concentration r e f e r e n c et e m p e r a t u r ies a l s og i v e n ,e . g ." G G T 3 1 . 0U / L 370C". . he 1 3 . O p e n t h e d o o r , r e m o v et h e r e a g e n t a b a n d d i s c a r dT Reflotroniris now readyIor anothertest. Reflotror@Capillarypipettor- For use with capillaryblood s p e c l m e n so n l y 1 . R e m o v ef o a m d i s cf r o m t h e R e f l o t r o n c3:0 p L C a p i l l a r yT u b e c o n t a i n e rR . e p l a c em e t a lc a p .T u b e sm a y n o w b e d i s p e n s e d i n d i v i d u a l l tyh r o u g ht h e h o l e i n t h e t o p o f t h e c o n t a i n e rT h e c a p i l l a r yt u b e sa r ec o a t e dw i t hl i t h i u m - h e p a r ai nsa n t i c o a g u l a n t 2 . L o o s e nt h e c o l l e t( k n u r l e dt i p l 1 / 2 t u r n c o u n t e r c l o c k w i s e 3 . I n s e r tt h e b a n d e d( c o l o r e d p) o r t i o no f t h e C a p i l l a r yT u b e i n t o t h e e n d o f t h e P i p e t t o rS. l i d et h e C a p i l l a r yT u b e i n u n t i l t h e b l a c kc a l i b r a t i o nl i n ei s f l u s hw i t h t h e e n d o f t h e c o l l e t E n s u r et h e C a p i l l a r yT u b e i s s e a t e d( u p a g a i n s t h e s t o p ) . 4 . T i g h t e nt h e c o l l e tb y t u r n i n gi t c l o c k w i s eu n t i ls n u g . 5 . O b t a i nc a p i l l a r yb l o o ds a m p l ea c c o r d i n gt o s t a n d a r d l a b o r a t o r yp r a c t i c e sH. e m o l y z e ds a m p l e ss h o u l dn o t b e u s e d 6 . T o u c h t h e e n d o f t h e C a p i l l a r yT u b e t o t h e c a p l t t a r yb l o o d s a m p l eT . h e b l o o dw i l l b e d r a w nu p t h e t u b e ,v i a c a p i l l a r y line. a c t i o n ,t o t h e 3 0 p L c a l i b r a t i o n 7 . W i p e a n y e x c e s sb l o o df r o m t h e e n d o f t h e t u b ew i t h a l i n t f r e et i s s u e .D o n o t t o u c ht h e b l o o ds a m p l ei n t h e t u b e w i t h thetissue. B. Drspensethe sampleonto the centerof the red separation zone. Do not touch the red meshwith the end of the C a p i l l a r yT u b e ;l e t t h e b l o o ds a m p l ef o r m a d r o p a n d t o u c n the drop to the centerof the separationzone g P l a c et h e r e a g e n t a b i n t o t h e R e f l o t r o n 'm e a s u r i n g chamberS . e e p a g e1 6 S t e pN o . 1 0 . .10. L o o s e nt h e c o l l e t ,r e m o v et h e u s e dC a p i l l a r yT L r b ea. n d d i s c a r di n a n a p p r o v e dc o n t a i n e r . N o t e : A s a n a l t e r n a t ep r o c e d u r eo, n e m a y f i r s td r a w u p t h e s a m p l ea n d t h e n s e c u r et h e C a p i l l a r yT u b e i n t ot h e P r p e t t o r M a k es u r et h e b a n d e d( c o l o r e d e) n d o f t h e C a p i l l a r yT u b e i s i n s e r t e di n t o t h e P i p e t t o rT. i g h t e nt h e c o l l e t . P r e c a u t i o n l: f a c l o t r s o b s e r v e di n t h e C a p i l l a r yT u b e , p l e a s ed i s c a r d .l f a p o r t i o no f b l o o dh a s a l r e a d yb e e np l a c e d on the reagenttab and a clot is observed,pleasedrscardthe t a b a n d C a p i l l a r yT u b e
The followingmessagesmay be seen during normaloperation: READY --
The Reflotron@is operationaland prepared for use.
REMOVE TAB --
There is a used tab in the measuring chamber.Open the door and remove the tab.
CLOSE DOOR .-
Reagenttab hasbeenlockedin place. Close the door to beginthe analysis. lf this messageappearsdirecilyafter the warm-upperiodpressthe release lever.
W A R M I N GU P 1 5 - -
The temperatureneededfor the measurementhas not yet been reached; t h e i n s t r u m e n ti s c o u n t i n od o w n t h e warm-up time. Magnetic code has not been read. Reinsertthe reagenttab or insert a new reagent tab. Be sure magnetic tape is downward and test area is forward.
NO PROGRAM --
C O D E E R R O R- -
- -T MEAS.INTERRUP
CLOSE DOOR --
The entire magneticcode cannot be read. Reinsertthe reagenttab with the test area forward. or insert a new reagent tab if necessary. The analysis has stopped because the door has been opened during analysis. Repeat the measuremen{ with a new reagenttab. After the MEASUREMENT INTERRUPTmessage,(see error messages,p9.27 ) close the door to bring the transporterinto the starting position.
T E M P X X . ' X " C- -
The temperaturein the measuring chamber is too high or too low. T h i s m a y b e d u e t o h i g ho r l o w r o o m temperature,direct sunlight,a n e a r b yh e a tp r o d u c i n gi n s t r u m e n o t ,r obstructed vents.
D I L U T EG G T - -
The initial reflectanceis too low, either becausethe enzymaticactivity is too high,or becausethe intensityof the color of the blood itself is too high. Dilute the sampleaccordingto package insert instructions.
19
,
-'::::'sYe:':_-_-f;
NO TAB --
The analysis began without a tab being inserted.Properly insert a reagent tab and close the door.
GLU < 10 mg/dL --
The result lies below the measuring r a n g e l i m i t , o r t h e r e a g e n tt a b w a s insertedand measuredwith no s a m p l ea p p l i e d .
G L U > 6 0 0 m g / d L- -
T h e r e s u l tl i e s a b o v et h e m e a s u r i n o rangelimit.
GGT< 5.0U/137'C--
I n t h e c a s e o f e n z y m ea c t i v i t i e st,h e chosen referencetemperature(here 3 7 ' C ) i s a l s o d i s p l a y e dR . e c o r dt h e result.
G G T . 2 O O U / L3 7 ' C - -
T h e s i g n " * " i n d i c a t e st h a t t h e r e a c t i o nd i d n o t f o l l o w l i n e a rk i n e t i c s . Repeat the determination,possibly . i l u t i o ni n a f t e rd i l u t i n gt h e s a m p l e D structions can be found below and also in the package insert.
Referto the Troubleshooting Guide for error messages. GeneralInformationConcerning Results The resultremainson the displayuntil a new reagenttab is inserted. The test areaof a usedreagenttab is'usuallyhomogenously colored.Possiblecolor variationson the edgesdo not influencethe result.Deeplycoloredsinglepointson the test area may attributeto falseresults;theseare usuallycausedby improperplacementof sample.Remember:Placesampleonly on the centerof the red protectivemesh and do not touch the pipettetip to the protectivemesh. A new pipettetip must be usedfor each sample. Run a Reflotron<F-Check strip once per week. Hemolyzedsamplesshouldnot be used. The Reflotron" Pipetteor Reflotron,.CapillaryPipettor(for c a p i l l a r yb l o o ds a m p l e ss) h o u l db e u s e dt o e n s u r ea c c u r a t e results.Thesepipettorsare designedto deliverthe appropriate s a m p l es i z e ;i n a d e q u a taem o u n to f s a m p l em a y a l t e rt e s t results. lf the GGT valueobtainedexceedsthe linearityof the test, repeatthe determination afterdilutingthe sample1:'1with isotonicsaline.Multiplythe resultdisplayedby 2. 20
.-a:si.it!3!uYii-:::*:-
0peratingPrecautions B e s u r et h e i n s t r u m e nits p r o p e r l yg r o u n d e da s i n s t r u c t e di n t h e I n s t a l l a t i osne c t i o no f t h i sm a n u a l l.m p r o p egr r o u n d i n g m a y b e a c a u s eo f i n s t r u m e nm t alfunction. D o n o t a l l o wa n y l i q u i d b , e s i d e s a m p l em a t e r i aal n d d i s i n f e c t a n ti n , s i d et h e i n s t r u m e nct a s e .W i p eu p a l l s p i l l s promptlyS . e e M a i n t e n a n caen d S e r v i c es e c t i o no f t h i s m a n u a l f o r c l e a n i n ga n d d i s i n f e c t i nign s t r u c t i o n s Precautions Maintenance A l w a y st u r n t h e R e f l o t r o n o , p o w es rw i t c hO F F b e f o r e u n p l u g g i n gt h e p o w e rc o r d .A l w a y su n p l u gt h e p o w e rc o r d w h e n c h a n g i n gf u s e s . W A R N I N G :D a n g e r o u sv o l t a g e s( e q u a li n m a g n i t u d et o t h e i n p u t l i n ev o l t a g e )a r e p r e s e n ti n s i d et h e R e f l o t r o n @ c a s ea t t h e p o w e rs w i t c h( i n c l u d i n gt h e p o w e rc o r d a n d p l u s ) ,a n d i n s i d e t h e p o w e rs u p p l y .A l t h o u g hs p e c i a lc a r eh a sb e e nt a k e nt o p r o t e c tt h e u s e rf r o m d a n g e r o u sv o l t a g e su, s ec a u t i o nw h e n r e m o v i n gt h e i n s t r u m e nct a s e . 0peratingLimitations U s et h e R e f l o t r o n .o n l y f o r i t s i n t e n d e dp u r p o s eD . o not a t t e m p t o c o n n e c tt h e R e fl o t r o n Gt o . )a n y u n a p p r o v ep dr i n t e r s . c o m p u t e r so, r i n s t r u m e n t sC. o n n e c t i o nt o a n u n a p p r o v e d i n s t r u m e nm t a y n o t o n l y c a u s ea n e l e c t r i c ahl a z a r db u t w i l l a l s ov o i d t h e w a r r a n t y . U s eo n l y R e fl o t r o n" r e a g e n t a b s f o r a n a l y s e s . T o o b t a i no p t i m u mr e s u l t sf r o m t h e R e f l o t r o n ,ssy s t e m b , ring the reagenttabs to room temperature(letstandfor at least30 m i n u t e s )b e f o r ep e r f o r m i n ga s s a y s R . e a g e ntta b v i a l sm a y b e storedat room temperature.Controlsmust be refrigerated. U s e R e fl o t r o n " '3 0 p L C a p i l l a r yT u b e s( C a t a l o gN o . 8 3 2 3 7 5 ) w i t h c a p i l l a r yb l o o ds p e c i m e n so n l y . P r e p a r e d s e r u m ,p l a s m a , a n d c o n t r o l sd o n o t r e q u i r et h i s a n t i c o a g u l a natn d interferences may be causedby its presence. T o e n s u r ep r o p e rf u n c t i o n i n go f t h e H e m o g l o b i n t a b s ,a s t a n d a r dp r a c t i c es h o u l db e e m p l o y e dt o v i s u a l l yi n s p e c t h e usedtabs for completeblood transferto the readingarea. ?1