SPECIFICATION Core unit c 701

200 racks/h 2000 tests/h

Maximum throughput 1000 samples/h photometric tests

Capacity of Module Sample Buffer (MSB):

Rack loader capacity: - 20 racks for sample material
300 samples (60 racks x 5 - 5 racks in a temperature-controlled compartment (1
samples) material
Loading capacity
Rack unloader capacity:
300 samples (60 racks x 5 Auxiliary port (to insert sample racks if core unit is out
samples)

STAT port Yes Located on the core unit

Absorbance photometry.
The following wavelengths are used:
340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700
Detection method - Linearity up to 3.0 ABS. Alarm level at 3.3 ABS.

38 measuring points
Reaction times - 3 - 10 min

Number of applications
-

Photometric 200
Calculated tests 8
Serum indices 3
Serum/plasma, urine, cerebrospinal fluid, su

Sample types -

Sampling cycle time - 1.8 s

Sample pipetting volumes - 1.5 - 35 µL (0.1 µL steps)

Sample liquid level detection (LLD) - Yes

Clot detection - Yes
Sample foam (bubble) detection - No
 cobas c pack large
Reagent cassette type cobas c pack MULTI

Capacity of reagent disks - 70 cassettes

Reagent storage temperature - 5 - 15 °C

Reagent pipetting volumes - 5 - 180 µL (1 µL steps)

-
Reagent volume control
Liquid level detection (LLD)
Reagent foam (bubble) detection - Yes
Reagent identification - RFID
Ready-to-use reagents - Yes
Reagent loading/unloading - Manual
Reagent positions on Reagent Manager - -
Reagent Manager temperature - -
Development channels - Available
Reagent probes - 4
Reaction volume - 100 - 250 µL
Mixer - Ultrasonic

Measuring temperature/ - 37 °C ± 0.1 °C

incubation bath temperature
Number of reaction cells (c modules)/
Number of incubator disk position (e modules) - 406
Number of reaction cell segments - 14
Noise ≤ 65 dB
Power consumption 1.0 kVA 3.0 kVA
Heat Emission 3600 kJ/h 10800 kJ/h
Approx. deionized water consumption - 36 L/h
High concentrated waste - 2.4 L/h
Low concentrated waste
 MODULE
c 702 c 502 e 801 e 602

2000 tests/h 600 tests/h 300 tests/h 170 tests/h

photometric tests photometric tests immunology tests immunology tests

odule Sample Buffer (MSB): Capacity of Module Sample Buffer (MSB):

sample material - 20 racks for sample material
emperature-controlled compartment (12 - 16 °C) for auto QC - 5 racks in a temperature-controlled
compartment (12 - 16 °C) for auto QC material

Auxiliary port (to insert sample racks if core unit is

(to insert sample racks if core unit is out of order) out of order)

Located on the core unit Located on the core unit

hotometry.
wavelengths are used:
450, 480, 505, 546, 570, 600, 660, 700 and 800 ± 2 nm.
o 3.0 ABS. Alarm level at 3.3 ABS. Electrochemiluminescence

38 measuring points 70 measuring points

3 - 10 min 3 - 10 min 9/18/27 min 9/18/27 min

200 100

200 200
8 8 - -
3 3
m/plasma, urine, cerebrospinal fluid, supernatant, other Serum/plasma, urine

Cerebrospinal fluid
Supernatant
Whole blood
Whole blood Oral fluid
Hemolysate
Amniotic fluid
Processed stool
Other

12 s per module 21 s per module

1.8 s 6s 24 s per measuring 42 s per measuring
channel channel

1.5 - 35 µL (0.1 µL
1.5 - 35 µL (0.1 µL steps) steps) 4 - 60 µL 8 - 40 µL

Yes Yes Yes Yes

Yes Yes Yes Yes
No No Yes Yes
 cobas c pack large cobas c pack cobas e pack green cobas e pack
cobas c pack MULTI 100 and 300 tests/pack 100 tests/pack

70 cassettes 60 cassettes 48 cassettes 25 cassettes

5 - 15 °C 5 - 12 °C 6 - 10 °C 20 °C ± 3 °C

5 - 180 µL (1 µL
5 - 180 µL (1 µL steps) steps) 6 - 60 µL 8 - 64 µL

Software-controlled Yes Yes

test count
Liquid level detection (LLD) -
Yes No Yes Yes
RFID Barcode RFID 2D Barcode (PDF 417)
Yes Yes Yes Yes
Automatic Automatic Automatic Manual
10 - 5 -
Temperature-controlled
18 - 32°C ± 3°C - -
Available Available Not available Not available
4 2 2 1
100 - 250 µL 100 - 250 µL 120 µL 160 - 200 µL
2 non-invasive vortex 2 non-invasive vortex
Ultrasonic Ultrasonic mixers mixers

37 °C ± 0.1 °C 37 °C ± 0.1 °C 37 °C ± 0.3 °C 37 °C ± 0.3 °C

406 160 94 54
14 8 - -
≤ 65 dB ≤ 65 dB ≤ 65 dB ≤ 65 dB
3.0 kVA 2.5 kVA 2.0 kVA 3.0 kVA
10800 kJ/h 9000 kJ/h 7200 kJ/h 10800 kJ/h
36 L/h 40 L/h 30 L/h 30 L/h
2.4 L/h 2.5 L/h ≤ 7.0 L/h 1.0 L/h
 ISE module

900 tests/h (1 ISE unit)

1800 tests/h (2 ISE units)

Located on the core unit

Ion Selective Electrodes

(Potentiometry)

3 ion-selective electrodes
Na+ (Sodium)
K+ (Potassium)
Cl- (Chloride)

Serum/plasma
Urine
Cerebrospinal fluid
Supernatant
Other

12 s (1 ISE unit)
6 s (2 ISE units)

15 µL,
10 µL decreased sample
volume for urine

Yes
Yes
No
 -
-
ISE Diluent
450 µL (1:46 for urine, 1:31
all others)
ISE Internal Standard
500 µL (for subsequent)

ISE Reference Electrolyte

130 µL

-
No barcode or RFID
-
-
-
-
-
-
-
Ultrasonic

35 °C ± 2 °C

-
-

0.5 kVA
1800 kJ/h
-
-
 Width
Module Layout Units
(A)

mm 1,020
Core unit
(incl. STAT port)
inch 40.2

mm 450
cobas ISE
inch 17.7

mm 1,500
cobas c 701
(incl. MSB)
inch 59.1

mm 1,500
cobas c 702
(incl. MSB)
inch 59.1

mm 1,500
cobas c 502
(incl. MSB)
inch 59.1

mm 1,500
cobas e 602
(incl. MSB)
inch 59.1

mm 1,500
cobas e 801 NA
(incl. MSB)
inch 59.1
Height Depth Footprint
Units Weight
(B) (C) (sq m)

930 1,140 kg 197 1.1628

36.6 44.9 lb 434

1 ISE unit: 171

1,150 1,140 kg 2 ISE units: 180 0.5130

1 ISE unit: 377

45.3 44.9 lb 2 ISE units: 400

1,350 1,140 kg 697 1.7100

53.1 44.9 lb 1,537

1,350 1,140 kg 759 1.7100

53.1 44.9 lb 1,673

1,300 1,140 kg 535 1.7100

51.2 44.9 lb 1,179

1,140 1,040 kg 585 1.5600

44.9 40.9 lb 1,290

1,620 1,140 kg 610 1.7100

63.8 44.9 lb 1,345

Auxillary Reagent Consumtion c702 and c502 Module

Cat.-No.c702 Cat.-No.c 502 Article

5352991190 5352991190 Multiclean = Sample Cleaner 1
5968828190 5968828190 Sample Cleaner 2
5172101190 11555448 216 Hitergent
5172128190 04489241 190 NaOH-D
5172136190 04489225 190 SMS,
5172152190 04489357 190 NACl 9% Dil, cobas c 702
5172179190 - NACl 9% SI Gen.2, 3000Tests cobas c 702

4880285190 4880285190 NAOH D Cleaning Soltuion ( Cell Wash 1)

4880307190 4880307190 Acid Wash Soltuion ( Cell Wash II)

Auxillary Reagent Consumtion on the cobas ISE module

Cat. No. Article Amount needed

11183974216 ISE Standard Low 220 Botlles / Year
11183982216 ISE Standard High 240 Bottles /Year
11489828216 ISE Compensator 0.5 Bottles / day
10820652216 ISE Reference Electrolyte 0.13 ml/test
4880455190 ISE Internal Standard Gen.2 1.2 ml /test
4880480190 ISE Diluent Gen.2 0.45 ml/test
11298500316 ISE Cleaning Solution ???
4663632190 Activator 104 Bottles / Year

Summary of Auxilary consumtion on e602

Cat. No. Article Consumt / determination [ml]

4880340190 ProCell M 2.2 (See also detailed List below)
4880293190 CleanCell M 2.2 (See also detailed List below)
3005712190 ProbeWash M 0.2
3004899 190 PreClean M 0.55
11298500160 Sys Clean

Cat.-No. Article
12102137001 Assay Tip/Cup Elecsys ModularE170
4880293190 CleanCell M 2x2 L Elecsys,cobas e
or
12135027190 CleanCell M 2L Elecsys,cobas e
11662970122 CleanCell Elecsys,cobas e

11662988122 ProCell Elecsys,cobas e

4880340190 ProCell M 2x2 L Elecsys,cobas e

11732277122 Universal Diluent 2x16ml Elecsys,cobas e

11732277122 Universal Diluent 2x16ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

3183971122 Universal Diluent 2x36ml Elecsys,cobas e

 Volume or tests Volume or tests
Data pc/unit/y c702 pc/unit/y c502 702 c502
4 weeks OBS 13 information pending 20 ml 20 ml
12 weeks OBS - information pending 20 ml 20 ml
10 mL / d 37 information pending 102 ml 59ml
102 mL / week 78 information pending 102 ml 50 ml
4 weeks OBS 13 information pending 119 ml 50 ml
4 weeks OBS 13 information pending 119 ml 50ml
4 weeks OBS 182 information pending 3000 -
one bottle lasts for
7000-9000
120 Bottles/year
determinations information pending 1800 ml 1800 ml
information pending 2000 ml 2000 ml

Volume
3ml
3 ml
1 ml
500 ml
2000 ml
2000 ml
100 ml
12 ml

Summary of Auxilary consumtion

Volume Cat. No.

2000 ml
2000 ml
70 ml
600 ml
100 ml

Amount needed
1Piece / TEST

2.2ml / TEST For:

 Cytomegalovirus IgM
Interleukin 6
Prostatic Specific Antigen
soluble FMS like Thyrosin Kinase 1
2.2ml / TEST For:
Human Chorionic Gonadotropin
2.2ml / TEST For:
Human Chorionic Gonadotropin
2.2ml / TEST
0.18 ml / RERUN For:
Cancer Antigen 15-3
14 Bottle / Year For:
Creatine Kinase - MB
free Human Chorionic Gonadotropin + beta
Pregnancy-associated plasma protein A
0.05 ml / RERUN For:
Creatine Kinase - MB
Digoxin
Folate
P1NP
Vitamin B12
0.16 ml / RERUN For:
Cancer Antigen 125
Osteocalcin
0.18 ml / RERUN For:
Cancer Antigen 19-9
Cortisol
Myoglobin
ProBNP
Prolactin
Troponin T
0.28 ml / RERUN For:
Cytomegalovirus IgG
Cytomegalovirus IgM
Immunglobulin E
Prostatic Specific Antigen
0.34 ml / RERUN For:
Alphafetoprotein
Carcinoembryonic Antigen
Ferritin
Prostatic Specific Antigen
0.36 ml / RERUN For:
Hepatitis B Surface Antib. (Total)
Human chorionic Gonadotropin + beta
14 Bottle / Year For:
Anti-HBc IgM
Cancer Antigen 72-4
CYFRA 21-1
Digitoxin
HAV Antibody IgM
Hepatitis B Antibody (Total)
Hepatitis B Antigen
Hepatitis B Core Antib. (Total)
Hepatitis B Surface Antig.
Hepatitis B Surface Antig.
Human Chorionic Gonadotropin
Immunglobulin E
Myoglobin
Prostatic Specific Antigen
Rubella Virus IgM
Thyroglobulin
Thyroglobulin
Toxoplasma Antibody IgG
Toxoplasma Antibody IgM
 Intended use
Carry-over evasion solution for S probe
Carry-over evasion AMPH-HbA1c
Detergent for water bath
Carry-over evasion,
Carry-over evasion
HiCo, lasts for ~ 6000 dilutions
depends on # tests/unit

To rinse and lean used reaction cells

Test soecific, to rinse and clean reaction cel

mmary of Auxilary consumtion on e801

Article
Volume Control on the module
Monitored by liquid level detection
Monitored by liquid level detection
Check of initial volume at reagent registration; monitoring by countdown
Check of initial volume at reagent registration; monitoring by countdown
cobas c pack large: Check of initial volume at reagent registration; monitoring by countdown 70 mL bottle: Monitored by liq

Given initial volume; reagent monitoring by countdown

Given initial volume; reagent monitoring by countdown

Consumt / determination [ml]

Volume
2000 ml
2000 ml
70 ml
600 ml
100 ml
Workflow for top 15 configuration - cobas 8000 modular analyzer series
Color Legend
Inventory update Activities for loading consumables and auxillary reagent
Reagent loading Activities for reagent loading
Calibration/Quality Controls Activities for running controls and calibrations
Maintenance Activities for maintaining instrument
When you see the red corner in a cell, hold the curser o

Summary hands on time - daily (in minutes)

The times are also representative for configuration s
including c 702 modules Inventory update Reagent loading

cobas 8000 <702> 1.50 3.00

cobas 8000 <c7012> 3.00 6.00
cobas 8000 <c7013> 4.50 9.00
cobas 8000 <c701 I c502> 3.00 6.00
cobas 8000 c7012 I c502> 4.50 9.00
cobas 8000 <c701 I c5022> 4.50 12.00
cobas 8000 <c7013 I c502> 6.00 12.00
cobas 8000 <c7012 I c5022> 6.00 12.00
cobas 8000 <c701 I c502 I e602> 4.50 9.00
cobas 8000 <c701 I c502 I e602 > 2
6.00 12.00
cobas 8000 <c7012 I e6022> 6.00 12.00
cobas 8000 c7012 I c502 I e602> 6.00 12.00
cobas 8000 <c7012 I e602> 4.50 9.00
cobas 8000 <c7013 I e602> 6.00 12.00
cobas 8000 <e6022> 3.00 6.00
cobas 8000 <e602 > 3
4.50 9.00
cobas 8000 <e6024> 6.00 12.00
* time for total configuration: 17.5 min with CC , e602 only 7.5min ;time for one CC module: 10.5 min ; time for ISE

Hands on time
Intervall per module (Min)
Inventory update daily 1.50
Reagent loading daily 3.00
Calibration/Quality Controls daily 4.00
e-service (IRD/HRD download, Instrument performance upload) daily 5.00
Maintain elect. Data (e.g. delet results) daily 10.00
processing green wash rack daily 2.50
cleaning instrument surface daily 1.00
cleaning ISE sample probe daily 1.50
cleaning reagent/ sample probe daily 3.50
cleaning probes an ziper daily 5.00
cleaning cell rinse nozzles daily 5.00
Emptying and cleaning the concentrated waste container daily 0.45
Air purge daily
Photometer Check daily
Reagent prime daily
Incubation Waterbath Exchange daily
Cleaning the ISE rinse station weekly 2.00
Cleaning the rinse station weekly 3.00
Cleaning the ISE drain ports weekly 0.45
Washing the reaction parts weekly 1.50
Cleaning cell covers weekly 9.50
Cleaning ProCell/CleanCell nozzles and replace reservoirs weekly 8.00
Cleaning the mixing and separation stations weekly 5.00
Cleaning the microbead mixer weekly 2.00
Cleaning the liquid flow path every two weekly 5.00
Checking the ISE dilution vessel monthly 0.45
Cleaning the ISE reagent aspiration filters monthly 3.50
Replacing reaction cells and cleaning incubator bath monthly 16.00
Cleaning the detergent aspiration filters monthly 3.50
Cleaning the radiator filters monthly 3.00
Replacing the Na, K and Cl elektrode every two month 6.50
Washing the ISE reagent flow path quaterly 3.00
Replacing the ISE pinch valve tubing quaterly 3.00
Cleaning the ultra sonic mixing quaterly 5.00
Cleaning the filter of the air ironizer quaterly 7.00
Cleaning the filter of the solenoid valve quaterly 3.50
Replacing the pinch valve tubings quaterly 5.00
Replacing the ISE reference electrode Every six months 2.50
Replacing the ISE syringe seals Every six months 5.45
Replacing the syringe seals Every six months 5.45
Replacing the photometer lamp Every six months 4.00
Cleaning the ISE diluent as needed 5.50
Replacing ISE sample probe - elimination of clogging as needed 5.00
Replacing reagent and sample probes - elimination of clogging as needed 3.40
Replacing nozzle tips cell rinse nozzles as needed 3.10
Draining the vacuum tank as needed 1.40
Cleaning the solid waste compartment as needed 5.00
Extended power OFF and ON procedures as needed 50.00
Cleaning ProCell/CleanCell stand and aspiration tubes as needed 5.00
dular analyzer series This page shall give you an overview over the action
They are
They are distinguished
distinguished between
between hands
hands onon time
time and
and
Hands
Hands on
on time
time reflects
reflects the
the labour
labour hours
hours for
for the
the labor
labor
Module
Module time
time gives
gives an
an information
information howhow long
long the
the mod
mod
nsumables and auxillary reagents The information is based on the draft operator manu
The information is based on the draft operator manu
ntrols and calibrations This data is based on the experience with the c701 c
The green cells
are available. indicate
They will otthat there
differ toowill
much.be more infor
corner in a cell, hold the curser over it and you have a explanation for the item.

me - daily (in minutes) Summary hands on time - weekly (in minutes)

Calibration/Quality
Controls Maintenance* TOTAL Inventory update Reagent loading

4.00 37.05 45.55 1.50 3.00

8.00 42.45 59 3.00 6.00
12.00 52.95 78 4.50 9.00
8.00 42.45 59 3.00 6.00
12.00 52.95 78 4.50 9.00
12.00 52.95 81 4.50 12.00
16.00 63.45 97 6.00 12.00
16.00 63.45 97 6.00 12.00
12.00 47.45 73 4.50 9.00
16.00 52.45 86 6.00 12.00
16.00 52.45 86 6.00 12.00
16.00 57.95 92 6.00 12.00
12.00 47.45 73 4.50 9.00
16.00 57.95 92 6.00 12.00
8.00 17.50 35 3.00 6.00
12.00 22.50 48 4.50 9.00
16.00 27.50 62 6.00 12.00
module: 10.5 min ; time for ISE module: 3.95 min; time for e602 module 5min

System time per

module (Min) ISE unit cobas c 701 module cobas c 502 module cobas e602 module

21.00 x x x
x x x
x
0.45 x x
x
0.45 x x
x x x
2.35 x x x
2.35
4.10
 2.00
x
0.45 x x x
x
42.00 x x
x x
15.00 x
x
x
30.00 x
x
4.10 x
51.50
5.45
x x
19.25 x
14.45 x
2.00 x
12.50 x x
x x
x x
30.00 x
7.25 x
6.05 x
2.35 x x
77.50 x x
4.00 x
4.50 x
4.40 x x
3.50 x x
x x
X
x
15.00 x
u an overview over the actions the operator has to performe on the instrument.
between hands
between hands onon time
time and
and module
module time.
time.
he
he labour
labour hours
hours for
for the
the laboratory
laboratory staff.
staff.
formation
formation how
how long
long the
the module
module is
is blocked
blocked for
for this
this action.
action.
d on the draft operator manual of July 2009 and will be updated regularly.
d on the draft operator manual of July 2009 and will be updated regularly.
e experience with the c701 configuration the table will be updated with the data for c702 as soon as they
otthat there
differ toowill
much.be more information added once it is available

kly (in minutes)

Calibration/Quality
Controls Maintenance daily Maintenance weekly* TOTAL

4.00 37.05 31.45 77

8.00 42.45 30.45 90
12.00 52.95 44.45 123
8.00 42.45 30.45 90
12.00 52.95 44.45 123
12.00 52.95 44.45 126
16.00 63.45 58.45 156
16.00 63.45 58.45 156
12.00 47.45 48.45 121
16.00 52.45 66.45 153
16.00 52.45 66.45 153
16.00 57.95 62.45 154
12.00 47.45 48.45 121
16.00 57.95 62.45 154
8.00 17.50 36.00 71
12.00 22.50 54.00 102
16.00 27.50 72.00 134
* time for one CC module: 14 min , time for ISE module: 2.45 min

Maintenenance steps that can be done in the background

The following tables display the maintenance items and checks and indicate in which op
performed.

Maintenance
ISE c 701 c 502
Item

Stand Masking Back – Paralle Stand By Masking Back – Parallel Stand Masking Back –

By ground l ground By ground

Reset         
Rack Reset

Photometer
     
Check

Cell Blank
     
Measurement

Incubation
Water      
Exchange

Air Purge         
Wash Reaction
  *1   *1
Parts
Reset         
Rack Reset

Photometer
     
Check

Cell Blank
     
Measurement

Incubation
Water      
Exchange

Air Purge         
Wash Reaction
  *1   *1
Parts

Reagent Prime   
Cell Detergent
     
Prime

Incubator Bath
     
Cleaning

Manual
  
Cleaning

Change
  
Reaction Cell

Change
Photometer   
Lamp

System Wash   
Sample Probe
       
Wash

ISE System
 
Wash

Reagent Probe
Wash

Bead Mixer
Rinse

e 602 Reagent
Wash

Pipetter Air
Purge

Sipper Air
Purge

MC
Preparation
e for ISE module: 2.45 min

checks and indicate in which operation mode they can be

1 c 502 e 602

Back – Parallel Stand Masking Back – Parallel Stand Masking Back – Parallel

ground By ground By ground

       

   

   

   

   

*1   *1
       

   

   

   

   

*1   *1

   

   

   

    

    

   

   

   

   

   

   

   
Reference Laboratories

we have currently 23 cobas 8000 reference laboratories world wide

we have at the moment no reference customers for cobas e801 module

http://rpd-pkb.dia.roche.com/Pages/DXH/dxh_cobas-8000.aspx

For speakers, please contact the MCE speakers office run by

Please contact the countries participating in the MCE.

http://rpd-pkb.dia.roche.com/DXH/MCE%20presentation.ppt
ld wide
801 module

spx

fice run by
CE.

tation.ppt
Frequently asked questions
What happens if one module has a break down?
How is a masked module brought back to into routine.
Can be Calibrators Run out of the cooled QC positions?

What is the auxiliary reagent consumption?

Can reagent packs be exchanged between cobas 8000 and cobas 6000?
Is the antigen excess function implemented?
Is the new standard rack applicable to all modules?

How is the priority of racks?

auto QC: how does the system ensures that only valid QC samples are used due to on board stability?
If there is more than one c pack of the same parameter on the rotor which one is the instrument using
for measuring?

What does it mean to load reagents during the day and interrupting routine?

workflow of STAT samples in the instrument

what do you recommend for reagent distribution within one module and between
the two modules (serial or parallel)

What is the impact, if the transportation line is blocked.

is it possible to retrieve Racks out of the system during operation
Do I know where the Rack is in the System?

how many FTEs (personnel) are necessary to run different c8000 configurations

how to argument against the number of PCs and screens?

Are the Auxiliary reagents at the same place as on Modular ?

How is the Quality of the Data and the TDM applications

If a Module is masked, can the corresponding MSB still be used?

Is the Data manager following the IVD directives?

which validations were done for the different sample types of the different parameters?

can racks also be unloaded through the back-up slot on the module sample buffers?
can the covers of the modules be opened during operation?
to what extent are the results of cobas 8000 comparable to the results of Modular Analytics? (we talk
about identical patient results and commonality throughout our cobas platforms,
What is the function of the metal plates over the cuvettes?

Is it possible to choose on which module the rerun will be done?

How does the e602 Module behaves in relation to the handling of different reagent lots on one module?
Is the Serum indices sensitivity depending on the aplication.
Is the auto QC bracketing based on the number of tests or samples possible?

Where to program a calculated result

is the dip in volume editable
How deep does the sample probe enter into the samle,when it measures the level with the liquid level
detection?
Is the Photometer Lamp the same like on cobas 6000
What happens when a clot is detected in a sample
Can the data manager calculate uncertainty.
Can the module sample Buffer of a masked module be used for routing of samples?
How do I activtate the STAT application on a e602

Is it possible that I can select on the e602 Module to run the a measuring on a specific measuring cell?
Will the 502 only ever use c pack small?
Will the 702 only ever use c pack large?
will a single c702 be available

if the instrument can not read a RFID chip. Can the operator rewrit it or replace it against n other one.
Is it possible to have a client setting for the data manager
How can I retrieval a QC Rack out of the auto QC compartment?

If the reflex is done on the Host, what is the timeout?

How are maintenance actions traced and how are they logged?

What needs to be done to move the data to an other data Base (Tore)
Mulitclean do we need more Auxiliary reagent than before?

Do I see if the instrument is calibrating or running a control?

Is the e-lab performance available on a real time mode?
What happens if we have foam on a reagent cassette?

c702 Specific Questions

Can the c 702 module have the assays assigned serially, half in reagent carousel one half in carousel
2?
Is an automatic cassette change over available for development channel?
Is it possible to exchange c packs between different c702 modules within the same configuration?
Is it possible to exchange c packs between different configuration?

Is it possible to load c-pack large manually to the reagent rotor

What is the white part over the Ultra sonic mixer?

Why is the instrument asking manual after reaction bath cleaning for a Reagent registration?
Does the Interlock only stop the corresponding module or the compleate system.

Can I use the Modular Racks on the cobas 8000 modular analyzer series?
Can the Reagent Manager be seperatly masked from the c702 Module?
How much time does it need to delete some data from the Data Review screen?

cobas e801 module Freaquently asked questions

can the system be conected to cobas 8100 or MPA

can current cobas 8000 systems be upgraded with cobas e801 module
is it possible to have cobas e602 and e801 in the same configuraiton?
which tests work with Assymetric QC
Are the pipetting volumina for Reagent and Sample the same like for e602?

Which tests can use the function of dublicate repeat

Against which instrument is takes the standartisation place?
How many Immunochemistry applications can a load on a cobas 8000 configuration

Expected Reagent on board stalibility?

How much maintenenance do I need per day, week, month
If i ask the instrument to return a sample, how long does it take until i have it back?
How often can I dilute a sample?

Is it possible to exchange e packs between different e 801 modules within the same configuration?
Is it possible to exchange e packs between different configuration?

Is it possible to load e-pack large manually to the reagent rotor of the cobas e801 module
Is t possible to use cobas e 602 reagent packs on the cobas e801 and vise versa

Does the e 801 module need to have a fix position in the cobas 8000 conifuration?
Can you load a 100 & 300 test kit of the same reagent?

When will QC be executed? Right when the pack is loaded or right before the pack is used?
Does the cobs e801 have sample integrity check, means HIL on top of the foam detection with the
camera?
What is the incubation temperature?
Is the initial thorough mixing of the e packs enough for 3 month?

Is the nr. of reaction cells higher than on the e602?

How is the maintenace on the cobas e801 module ? No daily maintenance? How long does the bi-
weekly maintenance take?
If one module is down in a configuration, can the others continue to work?
How about the system availability in US / EU?
Does the system offer full traceability?
What about the carry over risk? Calculated risk ?
High priority testing?
10 TSH tests in a series: does the system close the pack after each pippetting step?
Can the e801 be connected to cobas 8100?
What are the humidity and temperature limits for operating the cobas e801?
What is the cycle time?
Does the cobas e801 module have also ultrasonic mixing?
What is the dead volume in the primary tubes, secondatry tubes, MicroCups?
Is the measuring time the same?
How many determinations are possible with one bottle of PreClean, PreWash?
How is the water consumption?
Does the e801 have much more moving parts? More sensors?
Does the e801 have common spare parts with the e601/2?

Reagent related questions

What is the Master System used for the applications?
Will all assays need to be submitted to the FDA / registration bodies?
Can 100 and 300 pack sizes be mixed on one module?
How did we manage to keep the reaction time with the smaller sample volumes?
Do we have priority testing on the e801?
Waht is the life expectance of the measurinng cells in e801?

QC of stand by packs: when is it done exactly? In advance or right before the pachk is going to be
used? Can I choose?
How many cassettes can I load at simultaneously?
How does on board QC work?
Do the e packs need to be transported upright?
Which HIV test does Roche offer in Europe?
How is the lot-to-lot stability of the reagents?
Why do we need to do a QC fo every e pack (US)?
Will the assay performance will be the same?
When will I have the complete menu on the cobas e801 module?
Software related questions
Can we do calculation of results?
Can we do QC based on time intervalls?
Do we need a Data Manager?
Wenn ein Combo Kit z.B IgG enthält, kann dann diese IgG Kasette nur für Messungen für den Combo Kit verw

Workflow related Questions

Are there already Stencils for the e 801 module

What is the advantage of the Pre-wash and how can we ensure that this has not a negative influence on the
throughput?
- How will we make sure to position the fact that on the e 801 every parameter will have a pre-wash and on the
e602/e601 not? Or will this also be the case in the future on the e601/e602 ? If so, will this not have a negative
impact on the throughput/speed on the e601/e602?
- Will there still be carry-over alarms for the measuring cells?
- Will the new pre-clean also be available for e601/e602?
- Why was/is the formaldehyde needed on the e601/e602?
- Can the 100 and 300 epacks for the same parameter been loaded on 1 system at the same time?
- For TSH it is also not needed to prepare anything? No handling at all?
- Do we already know something on MTBRV? Maintenance time? Service time? When will we have data for this?
The operator can mask the corresponding module (set it inactive) and continue with its routine on the other mo
The complete system has to be brought to standby and the masked module has to be unmasked. After that the
No

The global deal calculator has been developed to support affiliates when making detailed offers to customer. Th
control....consumption is calculated based on patient result per parameter. The consumption is used for the cos
are considered.

The cobas 8000 should be integrated mid 2009. I will keep in touch with the GDC project team.

no
yes
The new Standardrack was never implemented in the market

see the rack flow explanation in the system description

As a basic rule: The instrument is distributing the racks to keep them as busy as possible.
When the on board stability is exceeded, the system will not perform an auto QC measurement out of this QC s
A Warning message will be displayed.
29.5.08 Indication by a yellow color on the second column in the screen: QC/Status
There can be at maximum one current cassette of a parameter per rotor.
Additional c pack of the same parameter can be placed as standby.

The operator has to shut down and restart the instrument. ( onlay valid for configurations with c701 and 602)
Which takes 15min. This can be set equally to a throughput reduction of 500 results in the hour the operator wa

STAT samples have to be placed on a red STAT rack and can be enetered into the system over the STAT port.
contected ot a MPA, the STAT rack has to be placed on the loading area of the core unit.
If the STAT Rack is the first rack on a Instrument not currently measuring samples, the rack is transfered direct
module where determinations are requested from.
On an instrument processing currently the routine, the STAT Rack will be placed in the Module Sample Buffer o
be processed from. On the Module Sample Buffer the number position for the STAT rack can be programed. T
next rack goin into the module. It queues behind the other racks in the processing line. Expected time frame for
after entering into the port maximum 8 min. (4 racks in the processing line a 5 samples a 12 tests/ sample multi

Parallel placement is recommended on the c702 module. To maintain the throughput.

The operator has the possibility to access to the transportation line by taking away the blue transparent covers
to a blockage.
In case the blockage is due to something different than a blocked rack, than operator can set the core unit inact
the module sample buffer. for this function the operator needs to mask the transportation line and feed the rack
rack loading back up slot. ( maximum 20 Racks at once / Buffer)
Yes with the SW Version 04-01. The Rack unloading process may take about 15 minutes on average. The unlo
In the Sample tracking screen can be searched for a sample by sample ID. If the instrument finds the sample ID
sample has passed the barcode reader at the core unit and is processed. The sample tracking screen display
( processing or completed). If it is completed the sample can be found on the Rack monitor screen.

Please look at the chapter Operator interaction and Maintenance

It is suggested not to place the data manager next to the instrument as an instrument screen. The data manage
the operator can comfortable validate results and sit for a longer time period. If instrument information is needed
seen and operator from the data manager via screen sharing.
See also System Description ISE Module; c702; c502 module overview

For the c502 Module the same like on the c501 the c702 data are still in preparation

Yes
If the ISE is masked the corresponding MSB can be used.
The MSB can only be masked as Service mask.
If the first MSB is masked. The ISE and the first c702 Module is masked.
If the first c702 Module is Masked the ISE is also masked. But the MSB is not masked and used by the instrum
This point is will be corrected with the SW Version 04-01.
If the seconde c702 Module is masked only the Module is masked the ISE is not masked.
Yes

no sample type specific cobas c 702 validation performed; most data were taken from the c 501 validation since

Only if the Instrument is in back up operation mode. Not during routine

Yes for the front covers for the c702. No for the covers in the back. No for the covers of the c502
The current MCE measurements in Sydney, Huntsville, Zurich show excellent comparability with MODULAR Me
comparisons under routine-like conditions over numerous of days
To Protect the reaction in the cuvett from light
Rerun of a test is done on the second c702 – we can’t configure the cobas 8000 in such a way because the sys
ensure the fastest and optimized TAT. It can happen that the rerun is done on the second c702 but only if this is
because at that time it ensures the fastest TAT.

Place 2 different reagent lots on e602 – same as the current situation on MODULAR ANALYTICS E170

No. Same like on MODULAR ANALYTICS

No.Only based on the time intervall.
There is the option on both the insturment and the data manager to program a calculated test. Only the function
used to to avoid mixing inforamation between the instrument and the data manager. On the data manager have
calculated results to be ordered. The results will be cominded on the data manager
no

2 mm
yes
The aspiration of sample material leads to a pressure change in the tubing fluid system connected to the sampl
pressure change is deviating from the pressure change defined for a normal sample a data alarm for a clot is ge
to the results. Pending determinations for this sample will not be pipetted. To all determinations requested for th
attached. The informaiton, of the ample status will be transfered to the Data Manager
yes
No
I install a STAT application on the instrument and activate the corresponding ACN number.

yes. It has to be taken in concidertation , that this practise has an effect on the throughput of the module.
yes
yes
no only in the comnination with c502 or an other c702 module.

No.
no
Go to QC / Status push the button unloading, select the QC Rack you would like to unload and confirm with ok

Timeout definable on the instrument (DM Communicaiton Setting window) ( within secondes) A too long timesp
rackflow on the instrument and therefor on the trhoughput.
If the DM has added a request about a new test in Automatic Rerun Test Selection informaiton, the analyzer wi
after sending the subsequent Automatich Rerun Test Selection Inquiry . The analyzer will remain in the mode u
request from the DM. This rund are refered to as relefx runs

On the Instrument: The peromed maintenance activities are logged. And it can be seen by whom the maintenan
you can see the coments.
A Maintenance Report can be printed that contains this information. Or it can be backed up. What was not be d

Everything is sent to data manager. From the control unit you can push back up data (Type CSV = Excel; data
the
CD or DVD. No USB.) From data manger you can save the data export print etc. Data is saved in traced doc. (
send to TSN; CD DVD; USB; HD; customers NET server. Set it up once than it is automatically done. Warning p
there.
Sample probe solutions for cleaning the ISE . 2. (Optional)

QC Rack apears on the data Review screen with a P for Processing.

For Calibrators: in the sample review Screen you see that the rack is within the instrument.
no. Uploasd is only once a day
You get a message that says you have a bubble or foam.

It is technically possible. The simulation tool will support the country in making the correct applictation assignem
instrument.
No
It is possible to exchange the c pack between Modules and Instruments.
The Module will perform a level detection for the c pack and recalculate the number of tests available in the c p
calibration available on the reagent rotor where it was placed, there have to be a new calibration be performed.
No
No. C-packs have always to be loaded over the Reagent Manager. All the Reagent inventory is handeld over th
reading ; decapping ; maintaining the reagent position.) The reagent rotors do not have an RFID reader.
To secure the vortex effect. That the air can go in so that if it mixes the fluid does not fo up the wall. Avoiding c

To perfom the reaction bath cleaning the instrument or module is powerd down. As the instrument can in the po
reagent compartment cover was opened or not, for security reason, it is registrating the reagent compartment.
It stops the compleate system.
Yes. But the cobas 8000 is identifying the Racks via the Rack Barcode and the Modular ANALYTICS system vi
that the rack barcode has lost over the years its quality. ( the lines are no longer so clear). This might lead to ba
(red alarm full instrument stop). To avoid this situation, we recomend to check the current customer racks on th
exchange those that ar not readable against new one.
No. It is planed to implement this function withb a Life Cylce SW Version for cobas 8000 planed for April 2011
100 patients are deleted within less than a seconde. Records are permanetly deleted.

yes
The conecctivity with the pre-analytical system is givenn form the beginning. With the launch of the cobas e801
yes
yes
n/A
no they are about 75% of the e602 volumes. The Ratios of reagents and Sample stay the same.
Exception is HIV Duo. Please check the volumens once the package inserts are available.

Anti-HCV II
HBsAg II
Anti-HBc
Syphilis
HTLV I/II*
Chagas*
HCV Duo*
HIV Duo*
The Standartisation of the cobas e801 module will be done against the cobas e601 module
with cobas 602 modules only= 100 immunochemistry applications in Total. Indipendent if I have 1 or 4 e602 mo
with cobas e801 modules only = 200 immunochemstry applications in Total. Indipendent if I have 1 or 4 cobas e
If I have a cobas 8000 configuration that includes cobas e801 and cobas e602 module, I can load 100 applicatio
and 200 applications for the cobas e801 module. Total 300 applications. Indipendent how many 602 or e801 m

we are aiming for an onboard stability of 120 days

Data will be able at Q2 2016

It is possible to exchange the e packs between Modules and Instruments.

In case for this reagent is no calibration available on the reagent rotor where it was placed, there have to be a
No

No. e-packs have always to be loaded over the Reagent Manager onto the cobas e801 module .
no

Partly: The e 801 module needs always to stand right hand side of the clinical chemistry modules. Preferably it
602 module. Because it allows for a more efficent sample routing if the higher throughput system stands left of
reduce the traffic in the system But it can also stand on the right hand side.
Yes you can use the same application with 300 and 100 test packs on a cobas e 801 module/ s within the same
en Combo Kit verwendet werden, oder auch für reine IgG Messungen? B:

Yes: See http://rpd-pkb.dia.roche.com/DXI/MN_RPD_2015_06_Roche%20Stencil%20Library%20v2016%20-%

be caneled.
e to droplets on the cell cover.
tion. Pre-condition is that they different Lot-numbers.
etchUp.pdf