Sysmex® CA-600 Series Analyzer

Quick Reference Guide

Table of contents

Hardware overview ................................................. 3

Software overview .................................................. 6
Maintenance .......................................................... 8
Loading reagents .................................................. 13
Sample processing................................................. 16
Operation symbols ................................................ 20
Quality control ...................................................... 21
Stored data ........................................................... 24
Enter lot information ............................................. 28
Calibration ............................................................ 29
System alarms ...................................................... 33
Coagulation curve errors ....................................... 34

SMN: 10734563 | T05010.014 | Effective date: 7/20/2021

07-2021 | © Siemens Healthcare Diagnostics Inc., 2021
2
 Hardware overview
Hardware overview
External(Front)
External (Front) hardware
hardware overview
overview
1. On/Off
1. On/Offswitch
switch
Turnsthe
Turns thepower
poweron
onand
andoff
off
2. Sampler
2. Sampler
Hasa aload
Has loadcapacity
capacityof
of one
one sample
sample rack
rack
with10
with 10sample
sampletubes
tubes
3. Lightshield
3. Light shield
Prevents photoelectricdetection
Prevents photoelectric detectionfrom
from being
being
affected by scattered light from external sources
affected by scattered light from external sources
4. Mechanical stop switch
4. Mechanical stop switch
Stopsthe
Stops theoperation
operationof
ofthe
the instrument
instrument
5. Printer
5. Printer
Settings, error messages, and results are printed
Settings, error messages, and results are printed
on thermal paper
on thermal paper
6. Touch screen
6. Touch screen
Displays analysis results, reaction curves, sample
Displays analysis results, reaction curves, sample
numbers, and conditions, etc.
numbers, and conditions, etc.

3
3

Hardware
Hardware overview
overview
Hardware overview
External (Rear)
External (Rear) hardware
hardware overview
overview
1. Tubetrash
1. Tube trashbox
box(not
(notshown)
shown)
Collectsused
Collects usedreaction
reactiontubes
tubes
2. Trapchamber
2. Trap chamber
Preventsthe
Prevents thewaste
wastefluid
fluidfrom
from flowing back
back
totothe
thevacuum
vacuumpump
pump
3. Fuseholder
3. Fuse holder
Location ofofthe
Location thetwo
twotime-lag
time-lag type
type fuses
fuses
4. Powerconnector
4. Power connector
For connecting
For connecting the themain
mainpower
power supply
supply
(via the supplied power cable)
(via the supplied power cable)
5. Hostcomputer
5. Host computerconnection
connection(not
(not shown)
shown)
The location of the connection to the
The location of the connection to the LIS
LISsystem
system

4
4
Hardware overview
Internalhardware
Internal hardware overview
overview
1. CA
1. CAClean
Cleanand
andBuffer
Bufferholder
holder
HoldsCA
Holds CAClean
CleanI,I,CA
CA Clean II, and
andBuffer
Buffer
2. Barcodescanner
2. Barcode scanner(not
(notshown)
shown)
Movesininfront
Moves frontof
ofthe
thesample
sample rack and
and reads
readsthe
the
barcodelabel
barcode labelautomatically
automatically

3. Detectionwells
3. Detection wells
Sample results aredetected
Sample results are detectedfor
for coagulation,
coagulation,
chromogenic,* and immunologic*
chromogenic,* and immunologic* assaysassays
4. Probe
4. Probe
Aspiratessamples
Aspirates samplesand
andreagents
reagents

5. Reactiontube
5. Reaction tuberacks
racks
Each rack holds
Each rack holds up upto
to 30
30 reaction
reaction tubes;
tubes;
two reaction tube racks can
two reaction tube racks can be be set
set
6. Reagent holder
6. Reagent holder
Holdsthe
Holds thereagents
reagentsonboard
onboard

*Sysmex CA-660
*Sysmex CA-660 System
System only only
55
Software overview
Software overview
1. Sysmex
1. Sysmexkeykey
Displayserror
Displays errorlist,
list,temperatures,
temperatures, and paper
paper feed
feed
2. Analysis
2. Analysisstatus
status
Displayssystem
Displays systemstatus
status
3. Rack
3. Rackreplacement
replacement
Indicatesififsample
Indicates samplerack
rackcan
can be
be replaced
replaced
4. Host
4. Hostcomputer
computerconnection
connection
Indicates if the HC isis connected
Indicates if the HC connected
5. Hand held barcode reader connection
5. Hand held barcode reader connection
Indicatesififthe
Indicates theHB
HBisis connected
connected
6. Start key
6. Start key
Start/Stop analysis
Start/Stop analysis
7. System status area
7. System status area
Displays error messages, analysis status, and
Displays error messages, analysis status, and
status of externally connected instruments
status of externally connected instruments
8. Data processing area
8. Data processing
Displays analysisarea
progress status, work list, and test keys
Displays analysis progress status, work list, and test keys
9. Menu processing area
9. Menu processing
Displays the menu area
for function selection. In selecting a menu,
Displays the menu for function
touch a key that shows the menuselection.
you wantIndisplayed
selecting a menu,
touch a key that shows the menu you want displayed
6
6

Software
Software overview
overview
Software
Softwareoverview
overview
1. StoredData
1. Stored Data
Displaysanalysis
Displays analysisresults
resultsfor
for samples,
samples, QC, standards
standards
2.
2. QCQC
Displaysquality
Displays qualitycontrol
controlresults
results on
on aa Levey-Jennings
Levey-Jenningschart
chart
3. StandardCurve
3. Standard Curve
Review,input
Review, inputstandard
standardcurve
curve data,
data, and
and order
ordercalibrations
calibrations
4. TestGroup
4. Test Group
Used totochange
Used changethe
thegroup
group displayed
displayed and
and available
availableto
toorder
order
5. Special Menu
5. Special Menu
Navigatestotoother
Navigates otherareas
areasof
of the
the software
software such
suchasasset
set reagents
reagents and
and rinse proberinse probe
6. Repeat
6. Repeat
Used to order same tests on an entire rack of samples
Used to order same tests on an entire rack of samples
7. ID No. Entry
7. ID No. Entry
Manually enter sample ID number and quality control
Manually enter sample ID number and quality control
8. Group
8. Group
Displays which group of tests is currently displayed;
Displays which group of tests is currently displayed;
there are three groups
there are three groups
9. Rack/ID No./Test
9. Rack/ID No./Test
Displays the rack number, rack position, and ID number
Displays the rack
of the sample number,
and rack position, and ID number
tests ordered
of the sample and tests ordered 77
Daily maintenance
1. Turn power off, wait 15 seconds, and turn on
2. Check/Replace distilled water Note:
Trans light calibration is automatically performed at start up
3. Load fresh buffer as needed and every 24 hours, if chromogenic or immunologic assay
4. Check/Empty waste container is included in the active test group.

5. Check/Discard pneumatic trap chamber fluid Note:

6. Check/Replenish reaction tubes Test group with DDimer Test or chromogenic test requires
OVB buffer onboard at startup of instrument.
7. Empty/Clean reaction tube trash box
8. Load CA Clean I and II
9. Run ‘Rinse Probe’
Special Menu > Rinse Probe > Set
10. Check/Prepare reagents
11. Clean sample probe
12. Check temperatures
Sysmex > Temperature
13. Remove condensation from reagent rack

Maintenance
Weekly maintenance
Weekly maintenance
Cleaninstrument
Clean instrumentexterior
exterior
1.
1. Wipe
Wipeoff
offstains
stainsusing
using aa cloth soaked with
withwater
water
and
andneutral
neutraldetergent.
detergent.
2.
2. Wipe
Wipethe
theexterior
exteriorusing
usingaa dry
dry cloth.

Cleaninstrument
Clean instrumentinterior
interior
1.
1. Open
Openthe thelight
lightshield
shieldcover
cover and check that
thatititwill
will
not fall down with its
not fall down with its ownown weight.
2.
2. Take
Takeout
outthe
thereaction
reactiontube
tuberacks
racks and reagent rack
and reagent rack. .
3.
3. Using
Usinga acloth
clothsoaked
soakedwith
with water
water and neutral
and neutral
detergent,
detergent,wipe
wipeoff
offstains.
stains. Clean likewise the
Clean likewise the
reaction
reactiontube
tuberacks
racksand
and reagent
reagent rack that were
rack that were
taken
takenout
outbefore.
before.
4.
4. Wipe
Wipeoff
offstains
stainsusing
using aa dry soft cloth.
dry soft cloth.
5. Close the light shield cover.
5. Close the light shield cover.

9
9
Quarterly maintenance
LED calibration Filter inspection and cleaning
Refer to the LED page to perform an LED Calibration. 1. Remove filter NO.598 located underneath of the
sampler in the front of the instrument.
2. Use a vacuum cleaner or similar tool to remove dust
Cleaning the rinse container from the filter.
1. Turn OFF the instrument power. 3. After cleaning, push filter NO.598 fully back into
2. Turn the cap of the rinse bottle counterclockwise place, in the reverse order of removal.
to release the pressure from the bottle. Place cap
on a clean paper towel.
3. Discard any remaining liquid in the rinse bottle. Note:
4. Add 250 – 300 mL of 70% isopropyl alcohol LED Autocalibration (coagulometric channels only):
to the rinse bottle. every 90 days using CA CAL S or monthly if Derived
Fibrinogen is reported
5. Replace the cap on the rinse bottle and
tighten securely.
6. Mix the alcohol inside the rinse bottle to make sure
it comes in contact with all surfaces, including the
float switch.
7. Discard the alcohol and rinse the rinse bottle well
with distilled water.
10
LED
LEDcalibration
calibration
Running LEDcalibration
Running LED calibration
1.
1. From
FromMain
MainMenu, pressSpecial
Menu,press SpecialMenu.
Menu.
2.
2. Press Special
Press Operate.
Special Operate.
3.
3. Press LED
Press LEDCalibration.
Calibration.
4.
4. Press Calibration.
Press Calibration.
5.
5. Enter
Enterthe
thetarget
targetvalue
value(100
(100-999)
-999) found in the
the
calibrators
calibratorsinsert
insertsheet
sheeton
on the table of
of assigned
assigned
values.
values.Use
Usethe
thenumeric
numeric keys
keys to enter the
the value
value
then pressEnter.
thenpress Enter.
6.
6. Move
Movethe
thecursor
cursortoto“Vial
“VialType”
Type” using q and
using ▼ and▼pkeys,
keys, EvaluatingLED
Evaluating LEDcalibration
calibration
and pressNext
andpress Nexttotoselect
selectthe
thecontainer
container 1. When the operation is completed, the LED Calibration
1. When the operation is completed, the LED Calibration
7. Update screen will appear.
7. Set the
Set thecalibrator
calibratorsolution
solutionin
in reagent
reagent holder 1.
holder 1. Update screen will appear.
8. 2. Check each well that is displayed.
8. Set CA
Set CACLEAN
CLEANI Iininreagent
reagent holder
holder 11.
11. 2. Check each well that is displayed.
9. Set, OK. OK: Available
9. Press
Press Set,confirmation
confirmationscreen
screenwill
willappear
appear press
press OK. OK: Available
*OK: Available. However, replacement is required
*OK: Available. However, replacement is required
within a few months
Note: within a few months
Note:
LED ERRxx: Not available
LEDAutocalibration
Autocalibration(coagulometric
(coagulometricchannels
channelsonly):
only): ERRxx: Not available
every
every90
90days
daysusing
usingCA
CACAL
CALS Sorormonthly
monthlyif ifDerived
Derived 3. Press FIX to update the new adjustments when all
Fibrinogen
Fibrinogenisisreported 3. Press FIX to update the new adjustments when all
reported wells are OK. Press Cancel to rerun the LED calibration.
wells are OK. Press Cancel to rerun the LED calibration. 11
11
As-needed maintenance
As-needed maintenance
As-needed maintenance
Replace
Replacefuse
fuse Replace
Replaceprinter
printerpaper
paper
Replace fuse Replace printer paper
1. Turn off the power supply and disconnect the 1. Remove the printer cover by raising its lower edge.
1.
1. Turn
Turnoff
power offthe
thepower
cord. powersupply
supply and
and disconnect thethe 1.
1. Remove
Removethe theprinter
printercover
coverbyby raising loweredge.
raising its lower edge.
power
powercord.
cord. 2. Raise the printer lock lever to unlock.
2. Remove the fuse cap holder at the rear panel while 2.
2. Raise
Raisethe
theprinter
printerlock
locklever
lever to unlock.
2.
2. Remove
Removethethefuse
fusecap
capholder
holder at the rear panel
rear panelwhile
while 3. Remove the paper roll core and attach a new
pushing the tabs using a flat-tip screwdriver. 3.
3. Remove
Remove
printer the
thepaper
paper roll. roll
paper rollcore
core and
and attach aa newnew
pushing
pushingthe
thetabs
tabsusing
usingaa flat-tip screwdriver.
screwdriver. printer
3. Replace the fuses and attach the fuse cap holders. printerpaper
paperroll.
roll.
3.
3. Replace
Replacethe
thefuses
fusesand
andattach
attach the fuse
fuse cap
capholders.
holders. 4. Place the printer paper as
4.
4. Place
Placethe
shown theprinter
andpaper
printer
(right) pushas
paper as
shown
shown
down (right)
the(right)and
andpush
lock lever push
to lock.
down
downthe thelock
locklever
leverto tolock.
lock.
5. Press the Sysmex key,
5.
5. Press
Press
then theSysmex
the
press P.FEED key,
Sysmex key,
key
then
thenpress
press P.FEED
P.FEED
to advance the paper. key
key
totoadvance
advancethe thepaper.
paper.
6. Attach the printer cover.
6.
6. Attach
Attachthetheprinter
printercover.
cover.

12
12
12
Loading reagents
Loading reagents
Set reagents
reagentsaccording
accordingtotothe
thetest
testprotocol and
protocol label
and label
on the
the reagent
reagentholder.
holder.
1. PressSpecial
1. Press SpecialMenu selectSet
Menutotoselect SetReagents.
Reagents.
2. Set reagents in their appropriate positions
2. Set reagents in their appropriate positions
ononthe
theinstrument.
instrument.
3.
3. Enter
Enterthe
thereagent
reagentvolume
volumeifif the reagent volume
the reagent volume
alarm is ON.
alarm is ON.

Note:
ItNote:
is not necessary to enter the reagent volume if the reagent
It is not necessary to enter the reagent volume
alarm is OFF, because the Sysmex CA-600 series analyzer has
if the reagent alarm is OFF, because the Sysmex
level sensing to recognize insufficient reagent.
CA-600 series analyzer has level sensing to
recognize insufficient reagent.

13
13

Loading
Loading reagents
reagents
Reagent positions
Reagent positions
Position
Position I (11)
I (11)
• CA Clean
• CA I position
Clean I position
• Room temperature
• Room temperature
• GW5, PV10, SLD vials directly
• GW5, PV10, SLD vials directly
• 4 mL cup requires an adaptor
• 4 mL cup requires an adaptor

Position B (12)
Position B (12)
• Buffer position
• Buffer position
• Room temperature
• Room temperature
• GW5, PV10, SLD vials directly
• GW5, PV10, SLD vials directly
• 4 mL cup requires an adaptor
• 4 mL cup requires an adaptor
Positions11––44
Positions Positions
Positions 55--10
10
• Cooled to 15°C • Room temperature Position II (13)
Position II (13)
• Cooled to 15°C • Room temperature
• GW5, PV10, SLD vials directly • GW5, PV10, SLD vials directly • CA Clean II position
• GW5, PV10, SLD vials directly • GW5, PV10, SLD vials directly • CA Clean II position
• 4 mL cup requires an adaptor • 4 mL cup requires an adaptor • Room temperature
• 4 mL cup requires an adaptor • 4 mL cup requires an adaptor • Room temperature
• (1) PT, (2) APTT, (3) Fbg, (4) DDi Buf • (6) DDi Reag, (7) CaCl , (8) DDi Sup, • 4 mL vial directly
• (1) PT, (2) APTT, (3) Fbg, (4) DDi Buf • (6) DDi Reag, (7) CaCl2,2(8) DDi Sup, • 4 mL vial directly
(10) DDi Dil
(10) DDi Dil
14
14
 types
Vial types
1. S
 ysmex44mL
1. Sysmex mLcup
cup 4. PV10
4. P
 V10(push
(push vial)
vial)
•• Holds • Holds up to 10 mL
Holdsup
upto
to44 mL
ml • Holds up to 10 mL
•• Dead volume – 0.2 mL • Used for CA Clean I and Buffer
Dead volume- 0.3ml • Used for CA Clean I and
•• Used • Dead volume – 0.9 mL
Buffer
Usedfor
forCA
CA Clean
Clean II, reagents,
II, reagents,
calibrators, and controls
calibrators, and controls • Dead volume – 0.9 mL
•• Use an adaptor
Requires in reagent
an adaptor in holder
reagent holder
2. SLD
2. •S
 Holds
LD up to 5 mL
• Dead volume – 0.4 mL
• Holds up to 5 mL
• Dead volume – 0.4 mL
3. GW5 (Gewinde – “twist top”)
• Holds up to 5 mL
3. G
 W5 (Gewinde –
• Used for reagents
“twist top”)
• Dead volume – 0.8 mL
• Holds up to 5 mL
• Used for reagents
• Dead volume – 0.8 mL
15
15
Select test
Select testgroup
group
A
A maximum
maximumof offive
fiveanalysis
analysisparameters
parameters can
canbebedisplayed
on a menuon
displayed test
a group.
menu testIf other parameters
group. If other are required,
parameters
suchrequired,
are as +Fbg and
such–Fbg, the test
as +Fbg andgroup
–Fbg,must be changed.
the test group
Test groups
must may only
be changed. begroups
Test changed when
may onlythe
becursor is
changed
on a rack
when thethat has is
cursor notonyet beenthat
a rack analyzed
has notandyet
“Start”
beenis
displayed in the
analyzed and upperisright
“Start” hand box.
displayed in the upper right
hand box.
1. In the Main Menu, press Test Group.
1. In the Main Menu, press Test Group.
2. Press Group 1, Group 2, or Group 3 to select the
TestGroup
2. Press Group.1, Group 2, or Group 3 to select the
Test Group.
3. Press Main Menu.
3. Press Main Menu.
4. Press FIX to return to the Main Menu.
4. Press FIX to return to the Main Menu.

16
16

Sample
processing
 Manually
Manually entering
entering work
work list list
1. 1.InInthe
theMain
MainMenu,
Menu,press IDID
press No. Entry.
No. Entry.
2. 2.Enter
Enterthe
thesample IDID
sample number.
number.
3. 3.Select
Selectthe
the parameter
parameter toto
bebe tested.
tested.
OO= =ordered
ordered
- =- not
= not ordered
ordered
4. 4.Confirm
Confirmthe thesettings
settings and
and press
press Enter.
Enter.
5. 5.Press
Pressthe Startkey.
theStart key.

6. 6.Select
SelectTube
TubePosition.
Position.
First Tube = start at the first sample reaction
First Tube = start at the first sample reaction
tube position
tube position
Continue = start at the next sample reaction
Continue = start at the next sample reaction
tube position after the last run
tube position after the last run

17
17
Automatic work
Automatic worklist
list
1. Set
1. Setthe
thesamples
sampleswith
withthe
the barcode
barcode labels
labels facing
facing
awayfrom
away fromthe
theanalyzer.
analyzer.
2. From
2. Fromthe
theMain
MainMenu,
Menu,press
press the Start key.
the Start
3. SelectTube
3. Select TubePosition.
Position.
FirstTube
First Tube==start
startat
atthe
the first sample
sample reaction
reaction
tubeposition
tube position
Continue==start
Continue start at the
the next
nextsample
samplereaction
reaction
tubeposition
tube positionafter
afterthe
the last
last run

18
18
Set sample
samplerack
rack
The
The Main
Main Menu
Menushould read“Replace
shouldread “ReplaceRack?
Rack?YES!”
YES!”
before setting
settingthe
thesample
samplerack.
rack.
1. Pull
1. Pullout
outthe
thesampler.
sampler.
2. Put the primarytubes
2. Put the primary tubes into
into the sample rack
the sample rackand
andset
set
the rack in the sampler (max. 10 tubes + 1
the rack in the sampler (max. 10 tubes + 1 STATSTAT
position).
position).Set
Setthe
thesample
sample with
with the barcodes facing
the barcodes facing
away from the analyzer.
away from the analyzer.

19
19
Operation symbols
Operation symbols
Symbols
Symbols
— Analysis
— A nalysis isisnot
notordered
orderedfor
forthe
the parameter
parameter
Analysis is ordered
Analysis is ordered
Analysis in progress
Analysis in progress
Analysis is completed
AAnalysis
nalysis isiscompleted
not completed due
to interruption or error
Analysis is not completed due
to interruption or error

20
20

Operation
symbols
OrderingQC
Ordering QC
1. PourQC
1. Pour QCmaterial
materialinto
intoaa cup.
cup.
2. FromMain
2. From MainMenu,
Menu,Press No.ID
PressNo. IDEntry.
Entry.
3.
3. Press QCand
PressQC andthe
thefile
filenumber
number (i.e. QC01).
QC01).
4. Selecttests
4. Select teststotorun.
run.
5. Enter.
PressEnter.
5. Press
6. Quit.
PressQuit.
6. Press
7. Place
7. Placethe
therack
rackinto
intothe
the sampler Start.
pressStart.
sampler and press

21
21

Quality
control
Quality
Qualitycontrol
controlmenu
menu
ViewingQC
Viewing QCresults
results
1.
1. From
Fromthe
theMain
MainMenu, Press QC.
Menu,Press QC.
2. Press Select Test in the QC menu.
2. Press Select Test in the QC menu.
3. Select
3. Selectthe
theTest
Testparameter
parameterthen
then the
the QC file to display
QC file
into
the QC menu.
display in the QC menu.

Note:
Note:
TheSysmex
The SysmexCA-600
CA-600series
seriesanalyzer
analyzerstores
storessix
sixdifferent
differentQC
QC
files for each test parameter. Each file stores up to 180 data
files for each test parameter. Each file stores up to 180 data
points. First points entered will be consecutively deleted
points. First points entered will be consecutively deleted
when additional points are added (first in – first out).
when additional points are added (first in – first out).

22
22
Printing QC
Printing QC
1. Press
1. QCfrom
PressQC fromthe
theMain
MainMenu.
Menu.
2. Display
2. Displaythe
theQC
QCchart
chartyou
you want
want to print,
print,
if ifnot
notdisplayed
displayedpress SelectTest.
pressSelect Test.
3. Selectthe
3. Select theTest
Testparameter,
parameter,then
then the
the
QCfile
QC filetotodisplay
displaychart
chart to print.
4. Press
4. Print.
PressPrint.
5. Press
5. GraphororList.
PressGraph List.
Graph:
Graph: Printsout
Prints outQC
QCdata
dataand
and QC
QC chart
List:Prints
List: Printsout
outQC
QCdata
dataand
and data list

Graph List
23
23
Stored data
Stored dataoverview
overview
1. From
1. Fromthe MainMenu,
theMain Menu,select StoredData.
selectStored Data.
2. Sample
2. SampleIDIDNo.,
No.,calculation
calculation parameter
parameter and analysis
analysisresults
resultsinin
termsofofcoagulation
terms coagulationtime
time or
or OD/min are
are displayed.
displayed.Failures
Failures
occurringduring
occurring duringanalysis
analysisexhibit
exhibit the following
followingerror
errorkeys:
keys:
***.* Analysis
***.* datanot
Analysis data not obtained due
due to
toerror
erroror
orother
othercauses
causes
---.- The
---.- Thecalculation
calculation parameter
parameter could not
not be
becalculated
calculated
+++.+ The
+++.+ calculatedvalue
The calculated value exceeded the
the available
availablenumber
number
ofofdigits
digitsfor
for display
display
3. Abnormal
3. Abnormalflags
flagson
onthe
theright
right of the sample
sampleID IDNo.
No.indicate
indicate
thefollowing:
the following:
mm Mean
Meanvalue
valuecalculated
calculated from
from replicates
replicates [Mark] Adds or removes a mark to the sample
!
! Dilution ratio other than 100%
Dilution ratio other than 100% was
wasused
used DATE Date of analysis
*
* Error flag, or variation in repeat testingtoo
Error flag, or variation in repeat testing toohigh
high TIME Time of analysis
> Result above the Upper Report Limit SEQ Sequence number of analysis (counting from power turn-on)
> Result above the Upper Report Limit ID No. Sample ID No. entered by operator, host computer, or
< Result below the Lower Report Limit
< Result below the Lower Report Limit barcode reader
+ Result is above the Upper Mark Limit RACK Rack number and tube position
+ Result is above the Upper Mark Limit
- Result is below the Lower Mark Limit OUT Data ouput flag:
- Result is below the Lower Mark Limit H disappears after transmission to the host
Note: P disappears after printout
Note:
<<
oror
> flag with
> flag Fibrinogen:
with Fibrinogen: redilution may
redilution may bebeconsidered.
considered.
**
flag supersedes
flag supersedes>> oror
< flag, but
< flag, limits
but areare
limits still displayed:
still evaluate
displayed: result.
evaluate result. 24
24

Stored data
Stored data output
Printing a single data point
1. Select Stored Data from the Main Menu.
2. Press [▲] [▼] [ ] [ ] keys to select data. Place
the black cursor on the result to be reprinted.
3. Press the More key to access the output option.
4. Press Output key.
Select Current to print the highlighted sample.
Select IP Graph to print with graph.
Select IP List to print results only.
Printing a batch
1. Select Stored Data from the Main Menu.
2. Press [▲] [▼] [ ] [ ] keys to select data.
Place the black cursor on the result to be reprinted.
3. Press Mark key on the Stored Data list display.
When the Mark key is press the analysis data in
the current cursor position will be marked Arrow
[▲] [▼] and select Mark for all desired results.
4. Press More key to access the ouput option.
5. Press Output key.
Select Marked to print the highlighted sample.
Select IP Graph to print with graph.
Select IP List to print results only.
6. After printing, press Marked All Clear to remove
all the marked samples.
25
Stored data output
Retransmitting a single data point to
host
1. Select Stored Data from the Main Menu.
2. Press [▲] [▼] [ ] [ ] keys to select data. Place the
black cursor on the result to be retransmitted.
3. Press the More key to access the output option.
4. Press Output key.
5. Select Current to print the highlighted sample.
6. Select Host Computer to transmit results to the
host computer.
Transmitting a batch
1. Select Stored Data from the Main Menu.
2. Press [▲] [▼] [ ] [ ] keys to select data. Place the
black cursor on the result to be retransmitted.
3. Press Mark key on the Stored Data list display.
When the Mark key is press the analysis data in the
current cursor position will be marked. Arrow [▲]
[▼] and select Mark for all desired results.
4. Press the More key to access the output option.
5. Press Output key.
Select Marked to print the highlighted sample.
Select IP Graph, to print with graph.
Select IP List to print results only.
6. After printing, press Marked All Clear to remove
all the marked samples.
26
Coagulation
Coagulationcurve
curvecomponents
components
1.
1. < 1.
PT< :PT : 100%
100% > >
Analysisparameter
Analysis parameterand
anddilution
dilution ratio of the
thedisplayed
displayed
reactioncurve
reaction curve
2. 2. ERR
2. ERR [ 0 ][ 0 ]
Errorcode.
Error code.When
Whenananerror
error occurs
occurs in analysis
analysisresult.
result.
Whenthere
When thereisisno
noerror,
error,00 appears
appears
3.
3. dH dH
DeltaHeight,
Delta Height,increase
increaseof
of scattered
scattered light intensity
intensity
in reaction process
in reaction process
4.
4. bH bH
BaseHeight,
Base Height,scattered
scatteredlight
light intensity
intensity at the
thestart
start
ofofanalysis
analysis
5. CH
5. CHNo.
No.
Detection
Detectionchannel
channelininwhich
which analysis conducted
analysis was conducted
6. Graph
6. Graphx x- -axis
axis
Plotted
Plottedasastime
timeininseconds
seconds
7. Graph
7. Graphy y- -axis
axis
Plotted
Plottedasaslight
lightscattered
scatteredintensity light absorbance
intensity or light absorbance
8. (50)
8. (50)
Sample
Sampleresult
resultcoagulation
coagulationdetection
detection point
27
27
Enter lot
Enter lotinfo
info
Press Standard
1. 1. Press Curve.
Standard Curve.
Press Select Test.
2. 2. Press Test.
3. 3. Select parameter key.
Select parameter key.
4. Press Lot No. Entry.
4. Press Lot No. Entry.
5. Press Reagent 1.
5. Press Reagent 1.
6. Press CHG twice.
6. Press CHG twice.
7. Enter reagent lot number using keypad. Press Enter.
7. Enter reagent lot number using keypad. Press Enter.
8. Enter lot expiration date. Press Enter.
8. 9. Press lot expiration date. Press Enter.
Enter Quit.
9. Quit.
PressINN
10. (For DDi) Repeat steps for Reagents 2, 3, 4 as needed.
10. Dil.DDi) Repeat steps for Reagents 2, 3, 4 as needed.
(For INN
11. Press
12. Repeat
11. steps to enter lot and expiration date.
Press Dil.
13. Press Calib.
12. Repeat steps to enter lot and expiration date.
14. Scan 2D barcode from calibrator insert sheet.
13. Press Calib.
15. Press Register. DO NOT ENTER LOT/EXPIRATION FOR OVB
14. Scan 2D barcode from calibrator insert sheet.
16. Press Return.
15. Press Register.
17. Press Fix.
16. Press Return.
17. Press Fix.
28
28

Entering
lot info
Calibration
Calibration
Beforestarting
Before startinga anew
new calibration,
calibration, print
print thethe
old old curve
curve
1. Prepare for calibration 3. Order calibration
1. Prepare for calibration 3. Order calibration
• Reconstitute reagents, calibrator, QC. • Press Main Menu, Standard Curve.
• Reconstitute reagents, calibrator, QC. • Press Main Menu, Standard Curve.
• Print current calibration. • Press Select Test.
• • Replenish
Print current
CA calibration.
Clean I. • Select
• Press Test.
Press parameter key.
• • Replenish
ReplenishReaction
CA Clean tubes.
I. • Press
• parameter key.
Verify lot numbers.
• • Enter Reagent
Replenish /calibrator
Reaction tubes.lots. • Press
• Verify Standard Analysis.
lot numbers.
Refer To Enter Lot info tab. • Standard
Verify Dil Set #9 for Fbg, #1 for DDi.
• Enter Reagent /calibrator lots. • Press Analysis.
Refer To Enter Lot info tab. • Enter
• Verify Dil Setcalibrator value
#9 for Fbg, in DDi.
#1 for cursor.
2. Loadreagents
2. Load reagents – Scan 2D barcode.
• Enter calibrator value in cursor.
• Load fresh, room temp OVB to B position. – Press Register.
• Load fresh, room temp OVB to B position.
• Change Test Group to view test – Scan 2D barcode.
• toChange Test Group to view test • Press Start.
be calibrated. – Press Register.
to be calibrated.
• Press Special Menu, Press Set Reagents. • 4.
Press Start.
• Press Special Menu, Press Set Reagents. Accept the calibration
• Load reagents into appropriate positions. 4. Accept
• the calibration
Press Set.
LoadCalibrator
• • Pour reagents into
(SHPappropriate
or DDi cal)positions.
into cup.
Press Print.
• Set.
• Press
• • Place
Pour in position(SHP
Calibrator 1 ofor
sample rack.
DDi cal) into cup.
• Print.
• Press Run Quality Control.
• Place in position 1 of sample rack.
• Run Quality Control.

29
29

Calibration
Calibration
Save and
Save andrestore
restorea calibration
a calibration
Savecalibration
Save calibrationtoto
aa file
file
1. Press Standard Curve.
1. Press Standard Curve.
2. Press Select Test.
2. Press Select Test.
3. Press parameter key.
3. Press parameter key.
4. Press STD File.
4. Use
5. Press STDtoFile.
arrow locate File No. 1, 2, 3.
6. Use
5. On arrow to
selected locate
File no., File
pressNo. 1, 2,File.
Save 3.
6. Press
7. On selected
Set. File no., press Save File.
7. Press Set.
Restore a saved calibration
Restore a saved calibration
1. Press Standard Curve.
1. Press
2. Standard
PressSelect Test.Curve.
3.
2. Press
Pressparameter key.
Select Test.
4. PressSTD
3. Press File. key.
parameter
5. Use arrow to navigate to file to be restored.
4. Press STD File. Note:
6. On selected File no., press Load File. Note:
5. Use arrow to navigate to file to be restored. Save and Restore from Files 1, 2, 3 only.
Save and Restore from Files 1, 2, 3 only.
7. Press Set.
6. On selected File no., press Load File.
8. Press Print.
7. Press Set.
8. Press Print. 30
30
Manually
Manuallyentering
enteringstandard curve data
standard
curve data
1. Press Standard Curve from the Main Menu.
2. Display the standard curve data of the desired parameter.
1. Press Standard Curve from the Main Menu.
3. Press Manual Entry.
2. Display the standard curve data of the desired
Enter the correct standard curve data on the numeric
4. parameter.
key pad, using the [▲] [▼] to move to the desired
3. Press Manual
position. Entry.
Confirm data by pressing Enter.
4. Enter the correct standard curvecurve
5. Once all of the correct standard data data
on the numericpress Quit.
is entered,
key pad, using the [p] [q] to move to the desired
Continue:
position. Returns
Confirm to the
data Manual Entry
by pressing screen
Enter.
Set: all
5. Once Sets
ofthe
theentered
correct data as Standard
standard Curveisdata
curve data entered,
and returns
press Quit. to the Standard Curve screen
Quit: Discards
Continue: the to
Returns entered data and
the Manual returns
Entry to the
screen
Standard Curve screen
Set: Sets the entered data as Standard Curve data
and returns to the Standard Curve screen
Quit: Discards the entered data and returns to the
Note:
Standard Curve screen
Entering standard curve data can be used to input PT, Fbg,
and other assays that contain standard curves.
Note:
Entering standard curve data can be used to input PT, Fbg,
and other assays that contain standard curves.
31
31
Using hand-held
Using hand-heldbarcode reader
barcode reader
to enter
enterstandard
standard curve
curve data
data
1. Press Standard Curve from the Main Menu.
1. Press Standard Curve from the Main Menu.
2. Display the standard curve data of the desired parameter.
2. Display the standard curve data of the desired
Press Manual Entry.
3. parameter.

3. The Manual
4. Press hand-held barcode reader is ready to read when the icon (displayed
Entry.
to the right) appears in the upper-right of the screen.
4. The hand-held barcode reader is ready to read when
5. the
If the
iconbarcode readstocorrectly,
(displayed a confirmation
the right) screen will appear to verify
appears in the
the values.
upper-right of the screen.
5. If Register:
the barcode confirms that the values
reads correctly, are correctscreen
a confirmation and returns to the Manual
Entry screen
will appear to verify the values.
Cancel: confirms
Register: discards the values
that and returns
the values to the and
are correct Manual Entry screen
returns to the Manual Entry screen
6. Once all of the values have been confirmed, press Quit to set the values.
Cancel: discards the values and returns to the
Manual Entry screen
6. Once all of the values have been confirmed, press
Quit to set the values.
Note:
Entering standard curve data using the hand-held barcode
Note:
reader can be used to input PT, Fbg, and other reagents
Note: Enteringvalues.
that contain standard curve data using the hand-held barcode
reader can be used to input PT, Fbg, and other reagents that
contain values. 32
32
System alarms
System alarms
Viewingsystem
Viewing systemalarms
alarms
1.
1. From
Fromthe
theMain
MainMenu, press Sysmex.
Menu,press Sysmex.
2. Press Error List to view alarms.
2. Press Error List to view alarms.
3. Date,
3. Date,time,
time,and
anderror
errorare
are displayed.
displayed.
4. Refer to the instruction manual for
4. Refer to the instruction manual details.
for details.

33
33

System
alarms
Coagulation curve errors
ERROR 002: Slight Coagulation
Notes:
ERROR 004: Analysis Time Over Check reagent — ensure reagent is not
expired, contaminated, or improperly
ERROR 008: Coagulation Curve Error: Caution Review Curve made. Also ensure that volume is adequate
and reagent is dispensed properly.
ERROR 016: (Overflow) Turbidity Level Over
Check sample — examine sample
ERROR 032: No Coagulation for clots, adequate volume, and
contamination. Follow your own lab
ERROR 064: Aged Sample protocol for sample acceptability and
redraw request.
ERROR 100: Range Over
For more information about
ERROR 128: Early Reaction Error Coagulation Curve Errors, please
refer to the CA-series Measurement
Evaluation & Check Methods Scientific
Bulletin

34

Coagulation
curve errors
ERROR 002: Slight Coagulation
Possible cause
Coagulation reaction was weak due to abnormal sample,
e.g. low fibrinogen, or a reagent problem exists.
Result message
Numerical result flagged by an asterisk (*).
Result message: “Slight Coagulation.”
Solution/Comments
• Check sample, check reagent volume and integrity.
• Verify delivery of sample and reagent.
• Re-analyze the sample. If re-analysis gives results
without an asterisk (*), that result may be reported.
• If Slight Coagulation error occurs again, and if the
curves are acceptable and if the results are equivalent
at the 50% coagulation detection point, the mean
of the two results may be reported as determined
by your laboratory policy.
ERROR 004: Analysis Time Over
Possible cause
Analysis was not completed in set detection time due
to sample, reagent, or cold buffer.
Result message
Numerical result flagged by an asterisk (*).
Result message: “Analysis Time Over.”
Solution/Comments
• Check sample for possible anticoagulant contamination,
hemolysis, lipemia, etc.
• Verify delivery of sample and reagent.
• Re-analyze the sample. If re-analysis gives results without
an asterisk (*), that result may be reported.
• If re-analysis gives Analysis Time Over error again, the
sample may not be capable of forming a firm clot. Follow
your laboratory’s alternate protocol.
35
ERROR 008: Coagulation Curve Error:
Caution Review Curve
Possible cause
There was an unexpected curve fluctuation due to abnormal
sample, reagent, or air bubble present in reaction tube.
Result message
No numerical result listed; instead ***.*.
Result message: “Coag Curve Error Caution: Review Curve
with analysis data.” NOTE: Numerical value may be obtained
in Stored Data, where it is displayed with an asterisk (*).
Solution/Comments
• Check sample, check reagent volume and integrity.
• Verify delivery of sample and reagent.
• Review the analysis data format for clot formation.
• Re-analyze the sample. If re-analysis gives results without
an asterisk (*), that result may be reported.
• If Coagulation Curve Error occurs again, and if the curves
are acceptable and if the results are equivalent at the 50%
coagulation detection point, the mean of the two results
may be reported as determined by your laboratory policy.
ERROR 016: Overflow (Turbidity Level Over)
Possible cause
Turbidity is too high for the analyzer to make analysis.
Result message
No numerical result listed; instead ***.*
Result message: “Turbidity Level Over.”
Solution/Comments
• Check sample for hemolysis, lipemia, etc.
• Verify delivery of sample and reagent.
• Re-analyze the sample, or re-analyze the sample
diluted with the buffer if protocol uses a diluted
sample (i.e., fibrinogen, Clauss method)
• If re-analysis gives a result without an asterisk (*),
that result may be reported.
• Do not report result without numerical values.
36
ERROR 032: No Coagulation
Possible cause
No coagulation reaction was detected due to abnormal
sample or reagent problem.
Result message
No numerical result listed; instead ***.*.
Result message: “No Coagulation”
Solution/Comments
• Check sample for possible anticoagulant contamination,
hemolysis, lipemia, etc.
• Verify delivery of sample and reagent.
• Re-analyze the sample. If re-analysis gives results
without an asterisk (*), that result may be reported.
• If re-analysis indicates “No Coagulation” again, follow
your laboratory’s alternate protocol.
DO NOT REPORT OUT A RESULT
WITHOUT A NUMERICAL VALUE.
ERROR 100: Range Over
Possible cause
A short time has been observed; e.g. for the PT (<7 sec)
or aPTT(<15 sec).
Result message
No numerical result listed; instead ***.*
Result message: “Range Over”
Solution/Comments
• Reagent contamination or lack of analyzer maintenance
could cause this message. The tech should check the
sample, reagents, and instrument condition.
• Review the analysis data format for clot formation.
• If sample, reagent, and instrument conditions are
acceptable, re-analyze sample and look for clot formation
in the reaction cuvette or follow your laboratory protocol.
37
ERROR 128: Early Reaction Error
Possible cause
An abnormally short aPTT result has been observed.
Results may be caused by an early reaction.

Result message
No numerical result listed; instead ***.*
Result message: “Early Reaction Error”

Solution/Comments
• Verify sample and reagent integrity along with
maintenance procedures.
• Print out the analysis data. Obtain the ERE
sub-code associated with the error.
• If an ERE 4 sub-code was obtained and re-analysis
produces equivalent results at the 50% detection
point, the mean of the two samples may be reported
as determined by your laboratory policy.
• If any other ERE sub-code was obtained and repeats
upon re-analysis, the result may not be reported. Refer
to your laboratory’s alternate protocol.

38
Innovin, and all associated marks are trademarks of Siemens
Healthcare Diagnostics, Inc. Sysmex is a registered trademark of
Sysmex Corporation of America. All other trademarks and brands are
the property of their respective owners.
Product availability may vary from country to country and is subject
to varying regulatory requirements.
Please contact your local representative for availability.
Note: This document is for supplemental use only, and not meant to
be used in place of primary technical materials.
This quick reference guide, and the software described within,
are copyrighted. No part of this may be copied, reproduced,
translated, or reduced to any electronic medium or machine-readable
form without the prior written consent of Siemens Healthcare
Diagnostics, Inc.

T05010.014 Effective date: 7/20/2021

© Siemens Healthcare Diagnostics Inc., 2021

Global Siemens Headquarters Global Siemens Healthcare Global Division

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