ApexBio EDGE User manual

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Blood Loclqlc Monltorlng $y*tem
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ApgXBiONo.T,Li-HsinRd.V,HsinchusciencePark,Hsinchu,Taiwan,R.o.c.
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r raiwan Tel:[phone]Fax:[phone] p/N65015010012 I
E-mail:[email protected]
Website:www.apexbio.com Rev.6/10 is
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User'sGuid

!r Tahle of ContenGs

IntroducGion
Thankyou for choosing
the EDGE
BloodLactate
Analyzer.
All of theinformation
thatwill be needed
to useandmaintain
theEDGEBlood
Lactate
Analyzer is included
in.thismanual.Pleasereadit carefullybefore
usingthesystem.
TheEDGEBloodLactate
Analyzer
provides
you with importantinformation
concerning
individualmetabolism
andoxygen
debt.
The EDGEmeasurement
deviceis especially
designedfor anapplicationby in a numberof disordersin-
cluding liver disease,heart
disease,
diabetesmellitus,
musculardystrophy,
thi-
aminedeficiency,
neoplastic
disorders.
Regardlessanapplication
canalsobe
effectedby medical
specialistsin application
canalso beeffectedby medical
specialist
in medialdiagnostic.Hereit is possible
to usemeasurement
results
asdecisionsupportfor followingmedical
treatments
of the patient because
of
the skilled
andqualified
resultevaluation
(lnVitro).
The EDGEBloodLactate
Analyzeris designedfor both personal
useandprofessional
use.

n
W
CodcGd
|il]
L-J
Monitor
Ch.d..r
BACK
I
E
H
llt
H
fl
Contents of IGt
TheEDGE
kit package
includes
the following
items.
. TheEDGEBloodLactateMeter . User's
Guide
. 3VLithium
CoinCellBatteries
(CR
2032) . LogBook
. MonitorChecker . Wallet
. TheEDGE
BloodLactateTest Strips . Puncturer
. Code
Card . Lancets (28G)
In addition
to the above
items,The Edgelactate
controlsolutionmay alsobe
purchased
to checkthesystem(P.20).
Please
contact
your nearest
authorised
dealer
whenneeded.
Compartment
FRONT

Meter ComponenGe
LCD&r€en -Displays informationthatguides usersthroughtesting
andsetup,andshowstestresultanderrormessages.
Shift Button & ----------Tum meter on andoff. Control selectionand steps of
EnterButton userprogrammablesetupin FunctionMode.
TestStip Holder ------lnsertion sitefor test strip. Locatedonthebottom at
front side of *ie meter.
Battery Compartrnent----Holdsone 3V Lithium coin cell battery to power the
system.Locatedon the backsideof the rneter.
i
MoniforCtiecker-------Used to confirmth;t the 6Gf meteris functioning
properly.
Code
Card
Port---------------lnsertion
sitefor codecard.
Located
at top of the
backside
of themeter.
CodeCard --Codes_the
meter for the test strips that havethe
samecode when insertedinto the codecard port. In_
seft the codecard with the code numberfacing up.
Onecodecardis packaged
with each
box of Test
Strips.

lJsinu Your MeGer for the First Time
Ett. @ry
*t6ry dp Cb&
Step 1 Press
anykey to turn on themeter.
Step2 A clock symbol"O" will flashon screen.
Press"ENTER"button
to enter
setupof the date
6 time in theorderof Year-Month-Day
and
then
Hour-Minute.
Step3: Thepre-set
Yearwill flashonscreen.
Press
"SHIFT"button
to scroll
through
the years
andpress"ENTER"buttonto enterthe correctYear.
Press
andholdon the "SHIFT"buttonfor quick searching
ofttre
years.THE
EDGE
Meterprovides
calendar
years
from 2005 to 2099.
Step4: Thepre-set
Monthwill flashon screen.
Press
"SHIFT"
buttonto scroll
through
the monthsandpress
"ENTER"
button to enterthe correct
Month.
Press
and
holdon the"SHlFfbuttbq for quick searching
of the
Month.
Step5: Thepre-set
Daywill flashon screen.Press
"SHIFT"
buttonto scroll
throughthe daysandpress"ENTER"button
to enterthe correctDay.
Pressandholdon the "SHIFT'button
for quick searching
of the day.
Step6: Thepre-set
Hour
will flashon screen.TheEDGEMeterusesam/pm
time clock.EachHouris ledby AM or PMPress
"SHIFT"button
to
scrollthrough
the hoursandpress"ENTER'
button to enterthe correct
Hour.
Pressand
holdon the "SHIFT"button
for quick searching
of the
hour.
Step7: Thepre-set
Minutewill flashon screen.Press
"SHIFT"button
to scroll
throughtheminutes
andpress"ENTER"
buttonto enter
the correct
Minute.
Keep
pressing
on the "SHIFT"button for quick searching
of the
minute.
Step& Press
the two buttonson the meter simultaneously
to returnto the
BloodTest ModeduringDateor time Setting.

I
TminqON/Otr M Sond
Step t Pressanykey to turn on the meter.
Step
2: TheLCD screen
will showa 4'digit codenumber,
unit of measurement,
dateE time,and
a symbolof test strip.
Step
3: Press
the two buttonson the metersimultaneously.
Step4: A symbolof head
"I " will flash
on screen.
Press
"SHIFT"buttonto
skipthis selection.
Step
5: A symbolof cable
" t " will flashon screen.
Press
"SHIFT"button
to
skip this selection.
Step6: A symbolof speaker
"4l)" will flashon screen.
Press
"SHlFTbuttonto
setON or OFF for beepsound
of the meter.
The "Speaker"
with wave
ahead
of the speaker
means
ON;the "Spealer"without wavemeans
OFF.
Step7:.Press
the two buttonson themetersimultbnpously
to returnto the
" BloodTest Mode.
Chanahm
Urtt of Masuanarrt
Stept Press
any key to turn on themeter.
Step2: The LCD screen
showsat the BloodTestModethat containsa 4-digit
codenumber( ffi Please
referto P.14
"Coding
the Meter"),unit of
measurement,
datet' time,anda symbolof test strip.
Step3: Press
the two buttonson the metersimultaneously
to enterthe Func-
tion Mode.
Step4: A symbol of head
"I " will flashon screen.Press
"SHlFT"button
to
skip this selection.
Step5: A symbolof cable
" t " will flashon screen.Press
"SHIFT' button to
skipthis selection.
Step6: A symbolof speaker"(r))"
will flashon screen.Press
"SHIFT"
button to
skip this selection.
Step7: A symbol of clock "S" will flashon screen.
Press
"SHIFT"
to skip this
section.

Step& The pre-setUnit of Measurementwill flash on screen.Press
"SHIFT"
button to change
from mg/dl to mmol/L or vice versb, andpress the
'ENTER" button to confirm the selection.Then,the displaywill retum
to the Blood Test Mode.
Une a,hc
hiGbr
To codethe meter with a code card,follow thesesteps.
Step t Locate the codecard in the packageof test strip.
step 2 Verify that the code number on the codecard matchesthe code num-
beron the test strippackage.
step 3: Insert
the code
cardwith the codenumber
facingup firmly andcom-
pletelyinto thecodecardport on the backside
of themeter.
Step4: Press
anybuttonto poweron themeter.
a\
a

Thecode numberdisplayedon the metershould
matchthecode numberon the
gmy iodecud
andon thefront of thetest strippackage.
Step5: A 4-digitcodenumber
will
displayon the meter
screen.Verify the code
number on the screenwith
that on the codecard and
that on the test ship pack-
age.The four numberson
the code card,meter,and
test strip bottle should
match.
Ch&inq thc Svttanr
Therearetwo ways to check performanceof the EDGE Blood Lactate Ana-
lyzer.
These
checksare
simpleandvery important
to ensure
accurate
lactate
readings.
1. The Monitor Checkerconfirins the meter is operatingproperly.
2. The Control solutions cenfirm the meter and test strips areworking together
properly.
lvlontur Ch&u lvfu$d;
It is recommended
thattheEDGEMeteris checked
usingthismethodwhen
themeteris new and
whenthe performance
of thesystemneeds
to be con-
firmed.
To dreck the meter usinga monitor checker,perform the following steps.
Step t Insertthe monitor checker into the test strip holder (whenthe Meter is
eithertumed onor off), theEDGEMeterwil now perform
a series
of
self-fesL
t

!
Step2 Themeterdisplay
screen
will show"OK"whenself-testing
is complete
Removethe monitor checker from the test strip holdel andthe screen
will then display
"Ctrl."
Step3: Press
"ENTER"
key to exit checking
the meter.
Conaol Sofutun Mctlpd:
Please
askyour authorized
distributorto purchase
The Edgelactate
controlso-
lution.
Thepurpose
of the controlsolutioncheckis to validate
the performance
of the
EDGEBlood Lactate Analyzer irsing a standardsolution with a known concen-
trationrange
of laciate.
A controlsolution
test that fallswithin the acceptable
range
indicates
the user'stechnique
is appropriate
andboth themeterandthe
test strip are functioning properly.
Whento perform a controlsolution test -
. whenever
thereis doubtthat themeteror thetest strips arenot working
properly.
. if themeterhasbeen
dropped,
storedbelow q- -10rc (14T) or above
55t
(131T),
or storedinhumiditylevels
above
95%.
. if the test strip bottle has been left open or hasbeen exposedto tempera-
turesbelow '*- 4t (39.2F) or above
30"C (B6F) and/or lightor humidity
levelsabove
85%.
lr

't
. if thereadings
apPear
to be abnormally
highor low'
Step t Perform Monitor Checkermethod up to Step 2
( @seeP.17,Monitpr Checker Method) andver-
ify the code number on screenis the same
with the codenumber printed on the bottle
Step2: The screenwill display
"Ctrl",
andtheninsertan
EdgeBlood LactateTest Strip.
Step 3: The screen will flash a symbol of liquid drop
" D" instructing applying the control solution.
w
ffiffi
To check the meter using control solution,perform the following steps.
t

Step
4: Apply a drop of controlsolutionon the yellow reaction zonein the
middle top of the test striP.
Step5: Thescreen
will showtiming bars'r-i that flashandthengradually
di-
rninish
for countdown.
Step
6: After the timingbarsdisappear
(inapproximately 45 seconds),
the
screen
will show
test result.Compare
the reading
on thescreen
to the
range
indicatedonthetest strippackage.
Remove
the test strip.
Step7: Remove
andproperly
discard
theused
test strip.
Step8:Thescreenwill display
at bloodtest mode'
Thetest resultof controlsolution
will nbt be stored
in memory., I
Perforyqing a Blood LaclHate Test
ObtaininaaDrcp of Blood
Step t Washhands
with soap
andwarmwaterand
dry thoroughly.
Warm water
stimulates
bloodflow to the fingers
making
it easierto obtaina sample.
Step2 Hang
the armdownat the sidefor 10to 15seconds
massage
through
the wrist,palm,
andthen finger.This canstimulate
thebloodflow to the
fingermorequickly.
Step3. Hold
the lancing
device(puncture)
or lancet against
theside
of the fin-
gerandlance
the finger.
Followmanufacturer's
instruction
for how the
lancing
device
(puncture)
or lancetshould
be used.
t

Ifthetemperatureiswithin
thetestingrange
of $ lOtto 40rc (50f
to1O4T),thescreenwillshow
asymbolof blood' D"indicatingto
applyblood.
Step2:TheMeter will self-testthe environm"ntt"f.
-- perature.
If the temperatureis out of mnge the
screenwill showa symbol of thermometdr+.
m
-nM
-
t@
rl---l-
at /r Fl -l rY
rI 9' q-n.l tr
I| u.ro,os ll
IHI
lml
lnl
ru
E-T--
s'[eP3:
il*'Hlil$fi..ffi
ffi"'B
test strip.
Gentlymessage
your handandfingertowardthe punc-
ture site to form a drop of blood(approximately: o). Do
not "milk,"or squeezearoundthe puncture
site.
*t.
HwuPct{ormaT*
Step t Followthe instruction
on page
15
"coding
the Meter."

'{
:E
H
o
GJ
m
A NOTE:
. DONOT touch the target
area
of thetest strip.
. DONOT smear
the blooddrop ontothe targetarea.
'?^",*T:i::;?::';:"T:ond
drcp
cibrood
= f , = I,
. DONOTproceed
testingif the yellowwir
isnotfullofbloodsample.lnsufficientblood
I I lll I ll
sample
may causeinaccurate
test result. \--!J, \-- I-Jl
step4: Thescreen
willshow
timing
bars
"--", andthebarswill
thenfrash
and
gradually
diminish
forcountdown.
step 5: After the timingbarsdisappear
(approxim
ately
45 seconds),'the
screen
willdisplay
testresult.
. Thetestresult
is automatically
storedin memory.
. Record
testresultinthepersonal
LogBgok.
Step
6: Remove
theusedteststrip.The
LCD
screen
ontheMeter
willshow
thecodemumber
anda flashing
arrow
next
to theteststripicon,
indi-
cating
theMeter
isreadyforanothertest.
Step
7:[fmoretests are
tobe
performed,
repeat
stepsI through5.
A NOTE:Themeasurementdoneoutside thetemperature
range
will
show
thetestresult
with
aflashing symbol
ofthermomefs;"'<".
A IMPORTANT
@Donotreuseteststrips
andlancets.Used
test
strips
and
lancetsshouldbetreatedasbiological
wasteand
disposeof
properly.
Undeptandinq
the te* raule
Expected blood Lactate levels for:
. Normal Range:9'45 mg/dL(2-5 mmol/L).
. HigherRange:
45 mg/dL to 89.1mS/dL( 5 -9.9
mmol,/L ) Shouldbe consid-
ered as severe hyperrlactatemia.
lf the result is higher than 45 mg/dL, pleasecontact your physicianor health-
care professional
immediately.
. Anaerobic threshold(lAT):22.5 '54 mg/dL About Muscle training.
{
t'
H
6..::1
@

TheEDGE
Meter automatically
stores
up to 3oo test results
with dateand
time.
when morethan30o test results
havebeen
performed,
theoldest
result
will be dropped
from memoryeach
time anew resultis added.
when the test
results
are
recalled
from memory,
themostrecent
resultis always
displayed
first
To view the results from memory:
step 1 Press
anykey to turn on the m€terandpress
the two buttonson the
metersimultaneously. !
step 2: A symbolof head
'fl ' will flash
on screen.
press"ENTER"
key to view
thelatestresult (withtest date
andtime)in memory.continueto press
the "SHIFT"
key to view the previous
resrllts.
step'3:Press
the"sHlFT'and
"ENTER"
keys
simurtlneously
to exit
viewing
memory.
Setting Time Afuer First Use
Etep t Pressany key to turn on the meter.
Step2 After the LCDscreenshowsa codenurnber,unit of measurement,date
t' time,andasymbolof test strip;
press
the two buttonsonthe meter
simultaneously
to enterthe FunctionMode.
Step 3 A symbol of head"I " will flash on screen.Press"SHIFT" button to
skip this selection.
Step4: A symbol of cable
" t " will flashon screen.Press"SHlFT"button to
skip this selection.
Stept A symbolof speaker
"(|))"
will flashon screen.Press
"ENTER"
button
to skip this selection.
StepG A clock symbol"S" will flashon screen.Press
"ENTER"
button to
entersetupof the datee' time in the orderof Year-Month-Dayandthen
Hour-Minute.
StepZ The Year
willflash on screen. Press
"SHIFT"
buttonto scrollthrough

the yearsand
press
'ENTER' buttonto enterthe correct
year.press
andholdon the'SHIFT" utton for quick searching
of theyears.THE
EDGE
Meterprovides
calendar
years
from 2O05
to 2099.
step & The Month willflash on screen.
Press
"sHIFT"
buttonto scrollthrough
themonthsand press'ENTER"buttonto enterthe correct
Month.
Press
andholdon the"SHIFT"
buttonfor quick searching
of the Month.
Step
9: The
Daywillflashonscreen.
Press
"sHIFT"
button
to scrollthrough
the
daysandpress "ENTER"
buttonto enterthecorrectDay.
pressand
holdon the "SHIFT'button for quick searching
of the day.
steplo TheHourwill flash
onscreen.
TheEDGEMeter usesam/prh time
clock.EachHour
is ledby a.m.
or p.m. Press"SHIFT"
buttonto scroll
throughthe hoursandpress"ENTER'but[on to enterthe correctHour.
Press
andholdon the "sHIFT"
buttonfor quick searching
of the hour.
stePlt. TheMinutewill flashon screen.
Rress
"s[lF,r" buttonto scrollthrough
the'minutesand press
"ENTER'button to enterthe correct
Minute.
Caring for the Meter
Caringfor the EDGEMeteris easy.Followthesesimpleguidelines
to keepthe
EDGEMeterworkingproperly.
Prccaniollr
. DO NOT take the EDGEmeter apart.
lf therearetechnical
problems
or
questions
in useof the meter,
please
callyour authorizeddealer.
Handle
the meterwith care- severeshock,suchasdroppingtheMeter,
coulddamage the electronics.
DO NOT try to cleanthe test strip holder.
DO NOT contaminatethe strip holder
with bloodor controlsolution.
&ongG
. The meter is designedto be used within the temperaturerangesbetween
q- 10rcto 40t (50F to 104T).
1

Avoidleaving
themeterin extremely
hot or coldplaces, suchasneara heat
source
or in anextremely
hot or coldcar.
Do not storeor usethemeteror test stripswherethey may be exposedto
highhumiditylevels,
suchasin a bathroomor kitchen.
Neverimmerseor holdthe meterunderrunningwater.
Chanfim $c Bat{rl'ly
TheEDGEMeter operates
onone 3V Lithium coincellbatterywhichshould
maintain
at Ieast1,000bloodtests.Whenthe LCD screen
displaysa symbol of
'{iF-=,',
thisindicates
thebatteries
arelow andshouldbe replaced
arysoonas
possible. ,
To replacethe battery:
Step 1 Openbatterycoveron backsideof the meter.
Step2: Removethe oldbattery from the batterycom'
Qanim tlp lv'lctq
To cleanthe outside
of theEDGEMeter,usealint-freeclothdampened
with
soapwateror alcohol.
partmentand
replacewith anew one.
Step3:Replace
the batterycover.
t

Solving Prohlems
lf thereis a problem with the way you are performing a test or if there is a
problem with the EDGE Meter, any of the following messagesmay appear on
the meter screen.
If you havefurther questionsafter reviewingthesemessages,callour autho-
riseddealer.
'Code --..' The code card has been
damaged.
The batteries in the meter
are runningout of power.
Inserta new code card from a
new pachage
of test strips,fol-
low the procedureson p.14"
coding the meter."
lf problem persists,
callthe au-
thorized dealer.
Replace
the batteries.
._na
'.trt'
.rm:'
Hl
m
The monitor has not been
coded with a code card.
. Insertthe code cardthat is in-
cluded in the test strip package
into the code card port on the
top of backside of the meter,
and insert a test strip into the
test strip holder at the bottom
on the front of the meter.
The temperatureof the
meter is below its operat-
ing rangeof < 1O"C
(<50"F).
The meter needs to be moved to
an area
that is within the meter's
operatingrange,
10'Cto 40'C (50"F
to 104'F)-t'^. .,r,il,l
E
-g
1
o
3
ct

The temperature
of the
meteris aboveits operat-
ingrange
of >4O"C
(>104T).
MonitorCheckerresult
fails.
. Usedor
strip defectivetest
Thebloodlactate
result
is lowerthan6mg,/dl
(O.7
mmol/L).
Themeterneedsto bemovedto
anarea
that is within themeter's
operatingrange,
10'c to 40"c (50T to 104T)"t-.
Repeatthe test with anew test
strip.lf this message
continues,
calltheauthorised
dealer.
:
Repeat
the test to confirmthe
.test
lesult.If it readsLO again,
.cprltact
your healthcare profes-
.I'or':
Thebloodlactate
resultis
higherthan2OOmg/dL
(22.2mmol/L).
Repeatthe test to confirm the
testresult.
If it readsHIagain,con-
tactyour healthcare
professional.
The meteris damaged. Call
the authorizeddealer.
If you areunableto correctthe problem
afterfollowing
the What To Do proce-
dures,callyour authoriseddealer
in your country and/or contact
your health-
careprofessional
with questions andconcerns.
tt

Product WarranGyt
TheEDGE
BloodLactate
Meteris guaranteed to befreeof defects in work-
manship
andmaterialsundernormal
usefor aperiodof five (5)years from the
dateof purchase to theconsumer.
Theliabilityof Apex Biotechnology
Corp
is limitedto repairor replacement
and
in no eventshallApex Biotechnology
Corpbeliablefor anycollateralor
consequentialdamages
or loss. :
Instrumentssubjected
to misuse,abuse,neglect,
unauthorizedr6pairor modifi-
cationwillbe excludedfrom this warranty. i
Thisguarantee
specifically
excludesexpendablesrand
consumables.
All waqranty
claimsmust be directedto the Ape* Biotechnology
Corpauthor-
Thewarrantyapplies
onlyto the original
ptnehaser
of the system.
Specifications
Meten
Type:
Test Ships:
Test Range
Blood Source
SampleVolume:
Reading
Time:
HematocritRange:
Memory
OperatingTemperature:
RelativeHumidity:
Storage/ Transport Condition:
THEEDGEBloodLactate
Analyzer
EDGEBloodLactate
Test Strips
6 -200ms/dL(O.7'22.2
mmol/L)
Fingertip capillary
wholeblood
Approximately
than3pL
45 sec
35 - 50%
30Osetswith dateE time
10"cto 4o"c (50T to 1o4"F)
Lessthan<85%
(Storage,
Operating
andTransportation)
-10"C
to 55"C(14'Fto 131T)for meter
4"Cto 30'C (39.2'F
to 86T) forteststrip
t