Pc 400 Application _Ashraful (1).pptx

ABX Pentra C400
© 2018 HORIBA, Ltd. All rights reserved. 2
2018 PC400 App Training V1.21
Application
Training

Application Training
Description &
Specifications
Analytical Flags
ISE Module

Description
&
Specification

1 Physical specifications
2 Technical specifications
3 Computer specifications
4 Reagent range description
Pentra C400 Presentation

ISE Module
Sample Tray
Reagent Tray
Sampling System
Mixing System
Cuvette Changer
➢ Bench-top analyzer
➢ Dimensions : 100 x 65 x 57 cm
➢ Weight : 120 kg
➢ Screen: 12 inches
1. Physical Specifications

• External Modules:
- Cooling unit
- Tanks
- Printer
• Options:
-ISE Module
1. Physical Specifications

• Analysis method types:
- Spectrophotometry: Colorimetry and Turbidimetry,
- Potentiometry: Direct (Serum or Plasma) and Undirect (Urine)
• On-board Test Capacity: 55 parameters on board
- 52 cassettes positions or 39 tests positions with Reagent racks
- 3 ISE's (Na+, K+, Cl-)
2. Technical Specifications

• Throughput:
- Without ISE: up to 300 tests per hour
- With ISE: up to 420 tests per hour
450
400
350
300
250
200
150
100
50
0
With ISE
Without ISE
Throughput
0 20 40 60 80 100
% Bi reagent

• Sample Handling:
✓ Sample Capacity
- 60 samples on board + Continuous loading
- 6 racks with 10 sample positions for primary tubes or cups
✓ Positive Sample Identification
- integrated Barcode Reader and tube presence detector
✓ Sample Needle
- level detection
- shock detection
- clot detection

• Sample Handling:
✓ Sample Specimen
- Serum, Plasma, Urine, CSF, Whole blood, Homogeneous fluids
✓ Sample Volume
- Photometric mode: 2 to 95 µL (380 µL in 4 steps)
- ISE mode : 10µL (Undirect, U.) or 50µL (Direct, S/P)
✓ Automatic Sample Dilution
- from 1/2 to 1/22500
✓ Automatic Post Concentration
- from x2.0 to x10.0

• Calibrator and Control Handling:
✓ Calibrator/Controls Positioning
- Sample Tray or Reagent Tray
✓ Automatic Standard Dilution Series
- Dilution ratio: main direct : 1/2 - 1/150
- Dilution ratio: main Undirect : 1/2 - 1/150 8

• Reagent Handling:
✓ Number of Reagents on-board: 52 positions
- 44 in a closed refrigerated area (2-10°C)
- 8 at room temperature
✓ Positive Reagent Identification
- Integrated barcode reader
✓ Reagent Needle
- Capacitive Level detection
- Preheating

• Reagent Handling:
✓ Reagent Management with Cassettes
- automated Reagent On board stability check plus test
countdown
- unique cassette barcode
- back-up cassette
✓ Reagent Volume
- Minimum : 2µL with Sample needle
15µL with Reagent needle
- Maximum : 600µL

✓ Automatic Cuvette Changer
- Continuous loading and unloading of cuvette segments
- Total capacity : 36 segments (432 cuvettes)
• Reaction Handling :
✓ Reaction Cuvettes
- Disposable acrylic cuvettes
- Cuvette volume : Min 150µl - Max 600µl

• Optical System:
✓ Wavelengths
15 selectables from 340 to 700 nm
✓ Bichromatism Capability
✓ Light Source
Tungsten-halogen lamp
Photometer Reaction Cycle
12 seconds

Computer Hardware and Software
• Software
FULL QC
Validation Station
Logs
Interactive Help
User’s Channels
3. Computer Specifications

• A complete range ready to use
• Reagent menu allowing the
flexibility with 75 applications
including:
✓ Enzymes & substrats
✓ Ions & specific proteins as
Ferritin, Transf., Hapto,…
✓ CRP & CRP-HS
✓ HbA1C
✓ …
4. Reagent range description

Panels example:
• Hepatic: Total Bilirubin, Direct Bilirubin, Transaminase
ASAT & ALAT, ALP & GGT
• Glucidic: Glucose, HbA1c, Fructosamin
• Lipidic panel: Cholesterol, HDL Chol, LDL Chol, Trigly,
Apo A1 & Apo B
• Bone: Calcium, Phosphorus, ALP
• Cardiac: CK, CK-MB ASAT, LDH, Myoglobin, CRP HS
• Renal: Urea (BUN), Creatinine, Uric Acid, Micro Albumin
• …

Reagent range extensions
• DAT & TDM are running on
Pentra C400
14 DATs & 7 TDMs available
• Up to 15 additional User’s
channels
(can be extended to 40 according to
hardware modifications)
With Open cassettes 30/10
(ref A11A01922) and Vials can be used

Support

• On board Reagent Help
• Website
• International Technical Support
& Etools
(For Distributors and subsidiaries only)
Documentation:
Support

• Communication catalogue
• Excel summary file (in Technical Notes)
• Etools Catalogue
(For Distributors and subsidiaries only)
Catalogue information:
Support

Danke
Grazie
감사합니다
Obrigado
Σας ευχαριστούμε
谢谢
ありがとうございまし
た
நனற
Cảm ơn
Thank you
Dziękuję
धɊवाद
Merci
ขอบคณครบ
Tack ska ni ha
Большое спасибо
Gracias

Performance for Enzymes
Performances

Performance for Substrates
Performances

Performance for Specific Proteins
Performances

ALT GLUP
CHOL CRP
Performances

Test Equation
r2 correlation coefficient
ALT Y = 1.00 X + 5.00 (U/L) 0.9964
CHOL Y = 0.95 X + 0.04 (mmol/L) 0.993
GLUP Y = 0.98 X + 0.04 (mmol/L) 0.9974
CRP Y = 1.03 X - 0.18 (mg/L) 0.997
Correlation
Passing-Bablock regression
Performances

Reagent Stability and Sample Volume
Test Open Stability Sample Volume
ALT 42 Days 20 μL/test
CHOL 48 Days 3 μL/test
GLUP 83 Days 4 μL/test
CRP 64 Days 4 μL/test
Performances

Fast Instrument
• Albumin (BCG)
• Glucose (PAP)
• CRP (Latex turbidimetry)
• Complete BMP Panel
Performances

Reagent range extensions
• DAT & TDM are running on Pentra C400
14 DATs validated: Amphetamine, Barbiturate,
Benzodiazepine, Buprenorphine, Cannabinoid, Cocaine,
Ecstasy, Ethyl Alcohol, Methadone , Methadone Metabolite,
Opiate, Oxycodone, Phencyclidine & Propoxyphene
7 TDMs validated: Acetaminophene, Amikacine, Digoxine,
Gentamycine, Tobramycine ,Tricyclique (Antidepressant) &
Vancomycine
• Up to 15 additional User’s channels
(can be extended to 40 according to hardware modifications)
With Open cassettes 30/10 (ref A11A01922) and Vials can be
used
Performances

3
4

Software
System configuration
Training Annexe

Training Annexe
Software
COMPLETE SOFTWARE
Flexibility:
➢ Id. or pos.: if LIS or not (dedicated, Vet, Industry)
barcode tube or cup position
Easy to use:
➢ Backup: automatic reagent management
automatic recalibration if needed
➢ Create additional automatic filter: for Cal
➢ Automatic maintenance
Quality/traceability :
➢ Automatic data export

Training Annexe
Quality/traceability :
➢ Automatic database backup (8 working days max)
➢ Manual database backup (to help for support)
(for sales to follow activity)
Software
COMPLETE SOFTWARE
Flexibility:
➢ Language: English, French, German, Italian, Spanish, Portuguese, Greek
& Polish

Training Annexe
Software
COMPLETE SOFTWARE
Easy to use :
➢ Mono or Bi directional : ASTM format
➢ Query and Requery possible
Support :
➢ Integrated technical support/tool

Training Annexe
Flexibility:
➢ Printer: Customized printout (Logo, header,…)
➢ Printer installation: Only windows Driver required to get manual or
automatic printout
➢ QC Printout: with precision and/or accuracy curve
Easy to use and Secured :
➢ On board a complete validation station
➢ Westgard rules possible
➢ According LIS or not Set what to Review (Quality flag, Delta check,…)
➢ Automatic rerun out of Critical panic range
➢ Automatic post Dilution or post Concentration
Software
COMPLETE SOFTWARE

Training Annexe
Software
COMPLETE SOFTWARE
Easy to use and Flexibility:
➢ Customized Audible alert to be well informed on time
➢ Audible message set up by: type, volume intensity,
language,..
Easy to use and secured:
➢ Maintenance Alert can be set according use
➢ Most of the maintenance in automatic : daily & weekly

Training Annexe
Quality & Traceability:
➢ Customized by setting the user name and access
➢ Protected instrument use : Automatic logoff after time can be set.
Flexibility:
➢ Up to 15 User’s channel confiration
(can be extended to 40 according to hardware modifications)
➢ Sales Tool : Test Counter
➢ Perishable management: use of expired (reagents, calibrators,…),…
Software

Training Annexe
Application

Training Annexe
To create empty new
User’s Channel
(for Admin Level)
To see details or modify
unit, ranges,
Control required,…
To Copy a previous
methodology in a new
User’s Channel
(for Admin Level)
To Update/download
new Horiba’s Channels
To Change test order
(printout & Worklist
selection)
Application

Training Annexe
Test name
& code
Reagent
name
Range
(Anteriority
check,
Normal range
and critical
rerun range)
Correlation
(for
standardization)
Unit & decimal
selection
Application
Details 1/4

Training Annexe
Application
Details 1/4
Flexibility:
➢ Pretreatment (predilution) ½ up to 1/22 500
➢ Post Dilution / Post Concentration
➢ Unit selection protected (automatic calculation)
➢ Manual validation Possible (for special test independant
than validation station)
➢ Test name according User’s preference
➢ And activate only required test

Training Annexe
Security and rules:
➢ Delta Check or anteriority check
➢ Normal or reference range
➢ Critical rerun range (automatic rerun)
Standardization:
Instrument correlation possible
Application
Details 1/4

Training Annexe
SAMPLE NEEDLE
REAGENT
NEEDLE
Solution
Sampling Area
Dispensing
Area
Application
Details 2/4

Training Annexe
Cleaner before or after R1 R1+S R2
Application
Details 2/4
Sequence & wavelength
15 Wavelengths: mono or bi : 340nm …700nm

Training Annexe
Time
In second
Reagent
Needle
dispensing
Cycle time 12 second:
■ Volume flexibility: 2µL up to 95µL for Sample Needle
15 up to 600µL for Reagent Needle
➢ Dispensing flexibility: in any cycle new solution (reagent or sample or diluent)
can be dispensed by Needles
➢ Mixing Speed Flexibility: can be set from 0 up to 100%
Sample Needle dispensing
0
Absorbance
measurement
In Cycle
0
(R1 alone
reading)
12
1
(R1 + S
reading)
24 36 48
2 3 4
Application
Details 2/4

Training Annexe
Reagent 1
Reagent 2
Sample Reagent 3
Reagent 4
0 12 24 36 48
Time
In second
Application
Details 2/4

Training Annexe
Type: ENDPOINT / KINETIC / KINSEARCH
Reading point : 0 to 99 cycles (12s)
Application
Details 3/4

Training Annexe
Application
Details 3/4
Sample Quality:
➢ Sample limit (interferences)
➢ Reaction limit (substrat depletion)
➢ Antigen excess (hook effect or Prozone)
Reaction Quality:
➢ OD deviation check (div_abs)
➢ Reaction direction (Sign)

Training Annexe
Flexibility: All standard of Biochemistry from Enzyme to DAT &T
➢ 3 Calibrator predilutionType
(Factor, Main Direct & Main indirect)
➢ Calibration Mode:
Linear: - Factor
- Slope avg
- Linear regression
Non linear: - Linear inter
- Logit/log4
- Logit/log 5
- Exponen 5
Application
Details 4/4

Training Annexe
➢ Deviation
➢ Factor Checks:
Calibration & calibrator Quality:
Reagent Quality:
➢ Reagent range & Blank range checks:
Application
Details 4/4

Training Annexe
Application
PC400 Ratio
Ratio: set calculation between tests
➢ Flexibility : Used when the PC400 is not connected to a LIS

Training Annexe
Application
PC400 Profiles
PROFILES: list of tests pre-programmed in the worklist
➢ Flexibility : Used when the PC400 is not connected to a LIS

Training Annexe
Application
PC400 Incompatibility
INCOMPATIBILITY: list of incompatibility test
➢ Security : Used to program a cleaner when it is necessary between 2 tests on
same probe

Training Annexe
Application
PC400 Reagent
To change reagent use in Vial
or Cassette
To create new Reagent or Diluent for
User’s channel
Reagent: Select test in cassette or Vial + create new reagent
➢ Flexibility : Reagent format use (small or big consumption)
User’s Channel configuration (Open Channel)

Analytical and
quality flag

Kinetic analytical flags

Δ OD
3.0 for 340 nm
3.5 for others
HIGH_ABS
=> CALCHHK_ERROR
=> CTRL_ERROR
=>RERUN PATIENT SAMPLE
Time

OD
SAMPLE_LIMIT
Reading Time
Sample
limit => RESULT FLAGGED
(icteric, hemolytic, lipemic plasma)
Time

OD
Normal case
High Absorbance
Low Absorbance
High
Reagent Range
Low
Abnormal value
==> Reagent Pb
(expired, oxidation, ...)
Time
Reag_range

OD
High Absorbance
Low Absorbance
High
Normal case
Reagent Range
Low
Time
BLK_RANGE

OD
High
(Abs)
Normal case
Blank Range Low
( Abs)
Low
(Abs)
Blank Range High
( Abs)
Time
BLK_RANGE

OD
REACT_LIMIT
Reading Time
Reaction
limit
=> RERUN PATIENT SAMPLE
=> CALCHHK_ERROR
=> CTRL_ERROR
Time

NORMAL CASE
SIGN
(direction pb)
=> CALCHHK_ERROR
=> CTRL_ERROR
=> RESULT FLAGGED
Time
OD

OD
HIGH ACTIVITY
Reac_limit + sign
Reading Time
Reaction
limit
=> RERUN PATIENT (if post dilution)
=> CALCHHK_ERROR
=> CTRL_ERROR
SIGN CASE
REACT_LIMIT
Time

Div_ABS f
=> CALCHHK_FLAG
=> CTRL_ERROR

Div_ABS i
=> CALCHHK_FLAG
=> CTRL_ERROR

Div_ABS
=> CALCHHK_FLAG
=> CTRL_ERROR

Calibration Flags

DEVIATION
(dev. for replicates)
ΔOD
[Concentration ]
or activity
Calibration curve
Calibrant
conc.
Duplicate of normal case
Duplicate of abnormal case
too many difference
> of the expected %
Mean
Calibration flags

DEVIATION
(dev. for concentration)
The deviation represents the difference
between theoretical and calculated concentration
Δ OD
[Concentration ]
or activity
Calibration curve
Calculated
Concentration
Theorical
Concentration
Calibration flags

FACTOR RANGE
Δ OD
[Concentration ]
or activity
Calibration curve
Calibrant
conc.
FACTOR FLAG
Mean
FACTOR FLAG
Calibration flags

DEVIATION
(dev. for replicates)
OD
[Concentration ]
or activity
Calibration curve
Duplicate of normal case
Duplicate of abnormal case
too many difference
> of the expected %
Mean
Calibrant
conc.
Calibration flags
=> CALCHK_FLAG
Div-abs Dev
Blank
FACTOR FLAG
OD
Calibration flags

=> CALCHK_ERROR
Non
linear
Calibration flags

Result analytical flags

OD

AG_Excess
OD

For linear calibration
ΔOD
Low linear. High linear.
Linearity_high (post dil.)
=> CTRL_ERROR
=> RERUN PATIENT
Linearity_Low (post conc.)
[Concentration ]
or activity
Linearity

Low linear.
High linear.
Linearity_Low (post conc.)
Low Cal.
value
High Cal.
value
Linearity_high (post dil.)
=> CTRL_ERROR
=> RERUN PATIENT
For non-linear calibration or linear regression
ΔOD
[Concentration ]
or activity

Δ OD
Low Cal.
value
High Cal.
value
=> RESULT NOT DISPLAYED
(post dil)
CALC_RANG_LOW
CALC_RANG_HIGH
[Concentration ]
or activity

Δ OD
Low Cal.
value
High Cal.
value
=> RESULT NOT DISPLAYED
(post dil)
TEST_RANG_LOW
TEST_RANG_HIGH
[Concentration ]
or activity

CONF. RANGE HIGH
CONF. RANGE LOW
[Concentration ]
or activity
High value
Target
Low value
+
+ +
+
+
+
+
+ + + +
+
+
TIME
(TEST , DAY , MONTH)

REF_RANGE_LOW
REF_RANGE_HIGH
Signal
(ΔOD)
[Concentration ]
or activity
Calibration curve
Low range High range
Normal range
FOR
PATIENT

Analytical Flags Priority
■HIGH_ABS
■SAMPLE_LIMIT
■REAG_RANGE_HIGH / LOW
■NON_LIN
■HIGH_ACTIV
■REAC_LIMIT
■NOISE
■AG_EXCESS
■BLK_RANGE
■SIGN
■DIV_ABS, DIV_ABSi, DIV_ABSf
■TEST_RANGE_HIGH / LOW
■RESULT_CALC_ERR
■DEVIATION
■LINEARITY_HIGH / LOW
■CONF_RANGE_HIGH / LOW, CONF_RANGE_HIGH_W/LOW_W,
CONF_RANGE_HIGH_W1-6 /LOW_W1-6, WESTGARD_RULE_4-6
■CRITICAL_RANGE_HIGH / LOW
■REF_RANGE_HIGH / LOW
■CALC_RANGE_HIGH / LOW

QUALITY Flags

QUALITY Flags
R CAL_CONV Result converted using the CONV fonction are flagged with R
C CAL_ERROR If calibration is flagged with CALCHCK_FLAG and validate
manually, all following result are flagged with « C »
Q CTRL_ERROR If a default ctr is flagged and manually validated,all
foolowing results are flagged with « Q »
KE CAL_EXPIRED If the current calibration used is expired, the calibration is
flagged with « KE »and all following results are flagged with
« C »
CE CALIBRATOR_EXPIRED If the calibrator used is expired, the calibrationis flagged with
« CE » and all following results are flagged with « C »
QE CTRL_EXPIRED If the control used is expired, the control is flagged with
« QE », in case of default control flagged « QE », all following
result will be flagged « Q »
SE SOL_EXPIRED If the solution (reagent or diluent or cleaner) uesd is expired
,the result (cal, ctr, patient)is flagged « SE
I INCOMPATIBILITY If two incompatibles test samplings are performed after the
other without the programmed cleaning the second test
result is flaggedwith « I »

END

Danke
Grazie
감사합니다
Obrigado
谢谢
た
நனற
Cảm ơn
Thank you
Dziękuję
धɊवाद
Merci
Tack ska ni ha
Gracias

9
4

ISE MODULE
PRESENTATION

Potentiometry
Voltage measurement between a selective
electrode and a reference electrode.
The intensity is proportional to the selected
ion (by the selective electrode : Na, K, Cl,...).
Technique

Potentiometry
Technique

Technique

VOLTMETER
Technique

 Serum or plasma : sampling 60µl, use only 50µl.
 Urine : Sampling 20 µl, use 10µl + 60 µl of STD1
(We mix with the movement inside the tubing).
Fluidic diagram

C
A
L
I
B
R
A
T
I
O
N
S
T
w
o
p
o
n
s
c
a
i
b
r
a
i
o
n
:
t
l
t
i
The slope is set by SDT1 and SDT2 to determine the patient
concentration.
The calibration is done automaticaly every two hours , also during
initialisation.
O
n
e
p
o
i
n
t
c
a
l
i
b
r
a
t
i
o
n
:
Every 15 minutes a single point calibration
performed to check the intercept using SDT1.
is automaticaly
Calibration

CALIBRATION SLOPE
Calibration

R
E
A
G
E
N
T
S
 Standard 1 : Calibration (1pt & 2 pt), dilution and rinse
 Standard 2 : Calibration (2pt)
 Référence : Liquid used to close the mesure circuit.
 Reagents and electrodes are differents than which used on the
Yumizen C1200 ISE .
Reagent

N
O
R
M
A
L
S
V
A
L
U
E
S
N
a
+
:
N
o
r
m
a
s
v
a
u
e
s
1
3
0
t
o
1
5
0
m
m
o
/
l
l
l
l
K
+
: Normals values 3,5 to 5 mmol/l
C
l
-
: Normals values 95-107mmol/l
Patients

Software (Customer services screen)

Customer maintenance
■ ISE Activation (« conditionning ») :
• Daily (at the beginning of the day),
• Use serum or plasma.
■ ISE Cleaning :
• Replace Cl- electrode by dummy electrode (A11A01851).
• Use Deproteinizer CP (A11A01754).
• Clean Cl- electrode with thread (XEA935AS),
• Weekly
■ ISE Etching :
• Weekly (at the end of the day),
• Daily if more than 20 samples per day,
• Use Etching CP (A11A01769).
(Activation after cleaning maintenance)

C
U
S
T
O
M
E
R
M
A
I
N
T
E
N
A
N
C
E
 - 20 tests / day : Deprot and Etching 1 time/ week
 + 20 tests / day : Etching 1 time / day and Deprot + Etching 1 time/ week
 Activation (Serum/Plasma) : Every day, after each maintenance and when the
electrode have been changed
 Deprot CP & Etching CP : cleaning solutions for electrodes
D
E
P
R
O
T
t
r
e
a
t
m
e
n
t
w
t
h
A
B
X
P
e
n
t
r
a
D
u
m
m
y
-
E
e
e
c
t
r
o
d
e
(
R
e
.
A
1
1
A
0
1
8
5
1
)
i
n
f
l
i
C
h
o
r
d
e
p
a
c
e
l
i
l
See User Manual
Maintenance

L
I
F
E
S
P
A
N
O
F
E
L
E
C
T
R
O
D
E
S
 REF : 12 months
 Potassium : 6 months
 Chlore : 4 months
 Sodium : 12 months
Electrode

ISE MODULE
SOFTWARE
PRESENTATION

Main menu
Ready
To Use
In progress
(calibrations,
measurement,…)
Error on ISE
mecanical, fluidic,..)
=> Order Global
Initialization
Module not
initialised
(
Need Calibration :
-
-

Ise setting
Error on ISE
…
Module not
initialised

Ise service
Error on ISE
- RTU
- Calibration OK

ISE CALIBRATION
- RTU
- Calibration OK
Need Calibration :
Calibration Error
After a cleaning step
-
-

ISE CALIBRATION SETTING

ISE CLEANING
RTU
Calibration OK
Calibration
error

ISE CLEANING

Danke
Grazie
감사합니다
Obrigado
谢谢
た
நனற
Cảm ơn
Thank you
Dziękuję
धɊवाद
Merci
Tack ska ni ha
Gracias

Pc 400 Application _Ashraful (1).pptx

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