cobas® pure integrated solutions

Simplicity meets Excellence

For the use only of registered medical practitioners or a hospital or a laboratory

01 cobas e 402 analytical unit1
Up to 120 Immunochemistry tests per hour
28 reagent positions

02 Sample Supply unit1

Up to 50 samples direct loading
Up to 50 samples direct unloading
STAT port

03 cobas c 303 analytical unit1

Up to 450 photometric tests per hour
Up to 450 ISE tests per hour
Up to 750 tests per hour
(mixed mode photometric and ISE)
42 reagent positions
cobas® pure integrated solutions
Simplicity meets Excellence
Today more than ever, the importance of accurate and timely diagnostics is
clearly understood. The journey from blood collection to the final test result,
however, requires the highest level of dedication, expertise and diligence of the
laboratory staff.

To support you in this, Roche has developed innovative integrated solutions

renowned for quality and excellence.

cobas® pure integrated solutions is the newest member of the cobas®

family of systems which is designed to deliver excellence, while at the same
time simplifying your daily work. cobas® pure combines clinical chemistry,
immunochemistry and ISE testing on a footprint of just 2 square meters, giving
access to our broad menu of more than 230 parameters – including many
unique high medical value assays to labs who have to deal with limited space.

To simplify daily operation, cobas® pure comes with new features that minimize
the hands on work for the operators, thus saving precious time.

To ensure simple and effective work for network organizations, cobas® pure
provides fully standardized results and operation to cobas® pro integrated
solutions – Roche’s latest analyzer designed for larger labs.

Because simplifying any step of the journey can help deliver fast and
accurate diagnosis.
Your time is precious
We help you use it wisely
In the lab, every minute counts – for you and your team, for the physician
and the healthcare institution, for the patient and their family.
Empower your physicians
to take action faster
Standards are being raised across health systems, as patient and physician satisfaction
and fast clinical decision making are becoming more prominent quality metrics.
Choosing an analyzer that supports short and predictable turnaround times at peak
times is a key to meet these standards.
Get answers fast with short and predictable
turnaround times
cobas® pure integrated solutions is designed to support fast and predictable turnaround
times across all assays.

93 of Roche immunoassays have reaction time of 18 minutes or less, with STAT assays
having just 9 min reaction time.2

To offer full transparency, cobas® pure integrated solutions allows the operator to see the
time to result per sample and per test as well as the time to last result on all ordered tests.

Roche reaction times2

9 minutes

18 minutes

27 minutes
Benefit from reduced system preparation
and hands-on time
Free up staff time with reduced hands-on maintenance efforts
With cobas® pure integrated solutions, every effort has been made to reduce hands-on
maintenance tasks to a minimum. The new and smart concept of self-operating maintenance
executes maintenance tasks automatically in the background and reduces the manual
burden of daily maintenance to 8 min.1

Save time and costs with cobas® AutoCal

The clinical chemistry module of cobas® pure integrated solutions comes with a
significantly simplified calibration concept – automated calibration. With cobas® AutoCal,
new reagent lots for the majority of clinical chemistry tests are calibrated automatically,
without the need for manual calibration. This can lead to 56 less calibration events, saving
up to 105 hours of hands-on time yearly.* 3

* For a common, daily routine workload, as compared to cobas 6000 <501|601> Mid Volume Commercial Lab
Your space is limited
We help you make the best of it
cobas® pure integrated solutions is designed to deliver true
productivity for your lab and access to our complete Serum Work
Area assay menu on a compact footprint of just 2 square meters.
 Immunochemistry Configuration Serum Work Area Configuration Clinical Chemistry Configuration
Footprint 1.2 m2 Footprint 2.0 m2 Footprint 1.2 m2

*The width and depth dimensions shown here are the floor(footprint) dimensions 4
Consolidate clinical chemistry & immunochemistry on a single platform

One One One One One

sample tube for all CC & set of results platform to manage user interface to manufacturer to
IM tests to handle to track and to be trained on interact with partner with
Increase productivity with our
improved reagent carriers in clinical
chemistry and immunochemistry
Ready to use reagents
cobas® pure uses the latest reagent generation from Roche – cobas e pack green and cobas c pack
green. These reagents do not require any preparation, mixing, waiting or pre-opening. The operator can
simply take them out of the fridge and load them directly onto the analyzer.

No preparing No mixing No waiting No pre-opening

Industry’s leading onboard stability

Using space intelligently is about achieving the highest output within the existing space. The average
onboard stability for the immunochemistry reagents is 110 days, with 98 of the assays having an
onboard stability of 4 months. The average on board stability for clinical chemistry is 137 days, with
57 of the reagents having an onboard stability of 6 months.5,6

Immunochemistry5 Clinical chemistry6

• Up to 4 months onboard stability • Up to 6 months onboard stability

• ≈ 3 times longer average • ≈ 2 times longer average
onboard stability compared to onboard stability compared to
previous generation systems previous generation systems
cobas e cobas c
pack green pack green
Your team is pushed to their limits
We help them focus on the tasks that matter
Whilst the pressure to deliver continuously increases, keeping your team engaged
and focused on value-adding tasks can be difficult but is of paramount importance
for your lab’s success. The cobas® pure integrated solutions is designed to eliminate
hurdles that may cause unnecessary stress.
Safety of results1
Disposable AssayTips/AssayCups Sample Reagent

cobas pure immunochemistry analytical unit utilizes single-use disposable AssayTips

and AssayCups to completely eliminate the risk of sample carry over.

Liquid Level Foam Clot Liquid Level Foam

Carryover evasion program Detection detection detection Detection detection
The sample probes on the cobas pure clinical chemistry analytical unit are rinsed

inside and outside with deionized water each time after dispensing a sample. Clinical Chemistry Immunochemistry

Additionally, for applications that are sensitive to sample carryover, special wash can
be programmed for an extra wash of reagent probes, sample probes and reaction cells
with basic and acidic wash solutions.

Carryover Ultrasonic Single-use Single-use

evasion Mixing of sample AssayTip AssayCup
Ultrasonic Mixing program and reagent

The cobas pure clinical chemistry analytical unit features ultrasonic mixing for non-
contact mixing of sample and reagent to eliminate the risk of carryover during this event.

Reliability
cobas® pure integrated solutions is designed to deliver the reliability that Roche is
known for. With more than 75,000 analytical units globally, the cobas family of solutions
demonstrates a distinctive uptime* of more than 99 .7 Having a reliable analyzer
means less interruption of services and less time spent on troubleshooting, thus higher
productivity with more predictable turnaround times. 99 % uptime7

* Uptime: Percentage of the time when system is up and running vs. the time the system is not running
due to unplanned incidents.
Calculation: (365 days/Mean time between repair visit) × (Mean time for repair visit + Travel Time)7
Bring more confidence to your team
with reliable and safe solutions
Unplanned downtime and lack of confidence in results are some of the most stressful
things that can happen in the lab. They shift attention to time-consuming, hands-on
workarounds or sample reruns which can affect staff morale and motivation.

Additionally, they pose risks to the quality of results and the lab’s reputation. With
cobas® pure integrated solutions we deliver distinctive reliability through sound
system architecture and confidence in the results through various safety features.
Enable your team to work more
efficiently through standardized
solutions
Lab standardization enables you to do more work on fewer instruments,
through consolidation of workflow, systems and reagents.
Standardization also provides efficient and compatible solutions for
network cooperation.
Essential benefits of standardization
Improved speed and accuracy of care
Same reagents and detection technology mean standardized reference ranges which improve the speed and accuracy of care.

Simplified training and staff allocation

Common user interfaces between our cobas® systems simplify training and allow for flexible staff allocation as healthcare
centers are consolidating into larger integrated health networks.

Optimized patient management

Consistent results over time and across different locations enable optimized patient management.

Same Same Same Common

reagents detection technology reference ranges user interfaces

Central laboratory Satellite laboratory

cobas® 8000 modular analyzer series cobas® pro integrated solutions

cobas® pro integrated solutions cobas® pure integrated solutions

Emergency laboratory Independent laboratory

cobas® pure integrated solutions cobas® 8000 analyzer series

cobas® pro integrated solutions
cobas® pure integrated solutions
Your future is unpredictable
We help you succeed through continuous
access to innovations
Choosing the right solution and vendor to partner with is not a small undertaking – it is a choice that impacts your lab’s
ability to fulfill performance and quality standards but also your ability to remain competitive. At Roche we believe in the
power of innovation to advance and improve diagnostics – for a better future of the patients and your lab.
Support better outcomes by
delivering greater medical value
Focused innovation of our assay portfolio Commitment to exceptional assay quality
Extending evidence base Advanced assay design Designed for convenience
Extending the evidence-base for existing assays through clinical studies to generate higher awareness • Outstanding precision across measuring range • Short and predictable assay Turn Around Times
and broader access to innovation. • High sensitivity in areas where it matters • Low sample volume
• Wider measuring ranges, fewer dilutions • No reagent preparation required
New claims for existing assays and repeats
Generating new claims for existing assays for a wider range of application.
Consistent, standardized results
Discovery of new assays • Consistent patient results across all platforms
Menu expansion in the areas of unmet medical needs to help clinicians improve outcomes for their patients. • Excellent lot-to-lot consistency
• Assays standardized against reference method
Bring Personalized Healthcare to clinical practice or reference material
Supporting better patient care, contributing to health economics and empowering labs to play a greater
role in medical decision making.
Introducing the new generation
of solutions from Roche –
cobas® integrated solutions
 cobas® pure integrated solutions cobas® pro integrated solutions

Delivering seamless design today and into the future

Shared reagents Consistent Consistent Same Same assay

packs results operation technologies menu
cobas® pure integrated solutions
General technical specifications
Dimensions and Weights Width Depth Height Weight

Sample Supply Unit (SSU), 450 800 1,750 mm 200 kg

(excl. STAT port and incl. touch screen monitor)
17.7 31.5 70.0 inch 441 lb

cobas c 303 (incl. ISE) analytical unit 1,000 800 1,375 mm 400 kg

39.4 31.5 54.1 inch 882 lb

cobas e 402 analytical unit 1,000 800 1,375 mm 400 kg

39.4 31.5 54.1 inch 882 lb

SWA System Configuration 2,450 800 1,750 mm 1,000 kg

<c 303 | SSU | e 402>
96.5 31.5 70.0 inch 1,764 lb

cobas® pure integrated solutions

Specifications of the electrical power supply

Distance to system ≤ 5 m (16 feet)

Electrical supply Single Phase AC

200 / 208 / 220 / 230 / 240 V

50 / 60 Hz

Max. power fluctuation ≤ 10

Power consumption ≤ 4.0 kVA

Whole System: < 4.0 kVA

SSU: < 0.5 kVA

cobas c 303 AU: < 1.5 kVA

cobas e 402 AU: < 2.0 kVA
cobas® pure integrated solutions
General technical specifications continued
cobas c 303 (incl. ISE) cobas e 402

Deionized water supply and consumption

Distance to instrument ≤ 5m ≤ 5m

≤ 16 feet ≤ 16 feet

Conductivity ≤ 1.0 μS/cm ≤ 1.0 μS/cm

Water pressure 50 to 340 kPa 50 to 340 kPa

0.5 to 3.4 bar 0.5 to 3.4 bar

Water temperature > 12 °C ≥ 12 °C

> 53.6 °F ≥ 53.6 °F

Approx. deionized water consumption max. 16 L/h max. 12 L/h

Maximum liquid waste volumes

Highly concentrated liquid waste flow rate < 1.2 L/h ≤ 3 L/h

Diluted liquid waste flow rate < 14.8 L/h ≤ 10 L/h

Environmental conditions during operation

Maximum altitude above sea level 3,000 m 3,000 m

Floor conditions ≤ 1/200 or ≤ 0.5 inclination ≤ 1/200 or ≤ 0.5 inclination

Bearing load ≥ 5 kN/m2 Bearing load ≥ 5 kN/m2

Ambient temperature 0 – 2,000 m above sea level 18 – 32 °C (64.4 – 89.6 °F) 0 – 2,000 m above sea level 18 – 32 °C (64.4 – 89.6 °F)

> 2,000 m above sea level 18 – 30 °C (64.4 – 86 °F) > 2,000 m above sea level 18 – 30 °C (64.4 – 86 °F)

Ambient temperature fluctuation ≤ 2 °C/hour (≤ 3.6 °F/h) ≤ 2 °C/hour (≤ 3.6 °F/h)

Ambient humidity 30 – 85 30 – 85
 cobas e 402 analytical unit Specifications Excellent performance, simple to use and
Specifications of the reagent system beautifully designed. The new Immunochemistry
Reagent pack types
Reagent loading / unloading
cobas e pack green
Manual
analyzer – cobas e 402 analytical unit.
Reagent Identification RFID
Capacity of reagent disk 28 reagent packs

Reagent storage temperature 5 – 10 °C (41 – 50 °F)

Specifications of the sampling system

Sampling cycle time 30 seconds

Sample pipetting volume 4 – 60 μL (1 μL steps)

Sample Liquid level detection Available

Sample clot detection Available

Sample air aspiration detection Available

Specifications of the reaction system

Number of incubator disk positions 38

Reaction volume 120 μL

Incubator temperature 37 °C ± 0.3 °C (98.6 °F ± 0.5 °F)

Reaction times for tests 9/18/27 min

Mixer Vortex

Specifications of the ECL measuring system

Measuring Cell ECL measuring cell

Number of measuring cells 1

Maximum throughput* 120 tests/hour

*Throughput may differ based on the mix of test orders per sample
 cobas c 303 analytical unit Specifications

Specifications of the reagent system

The new cobas c 303 analytical unit – Reagent pack types

Reagent loading/unloading
cobas c pack green

Manual
combining photometric and ISE testing on a Reagent Identification RFID

footprint of just 1.2 square meters. Capacity of reagent disk 42 reagent packs

Reagent storage temperature 5 – 15 °C (41 – 59 °F)

Specifications of the sampling system

Sampling cycle time 8 seconds

Sample pipetting volume 1.0 – 25.0 μL (0.1 μL steps)

Sample Liquid level detection Available

Sample clot detection Available

Sample air aspiration detection Available

Specifications of the reaction system

Number of reaction cells 128

Reaction volume 75 – 185 μL (detectable reaction volume)

Incubation bath temperature 37.0 +/- 0.1 °C

Reaction time 3 – 10 min (1 min steps)

Mixer Ultrasonic

Specifications of the photometric system

Measurements per reaction cell/10 min 46

Photometer lamp 12 V, 50 W

Photometer Multiple wavelengths spectrophotometer

Maximum throughput* Photometric only: 450 tests/hour

ISE only: 450 tests/hour (150 samples/hour)

Mixed mode Photometric & ISE: 750 tests/hour

(300 photometric + 450 ISE tests/hour)**

HbA1c only: 225 tests/hour

* Throughput may differ based on the mix of test orders per sample
** The ISE unit and the c 303 photometric measuring unit share the same sample pipetter
 ISE unit (integrated in the c 303 analytical unit*) Specifications
Applications Na+: Sodium

K+: Potassium

Cl-: Chloride

Sample types Serum/Plasma, Urine

Number of electrodes Ion-selective electrodes: 3 (Na+, K+ and Cl-)

Reference electrode 1

Maximum throughput** ISE only: 450 tests/hour (150 samples)

Sampling cycle time 24 seconds per sample for ISE

Electrode handling 2D barcode placed on the electrode package

Sample Liquid level detection Available

Sample clot detection Available

Sample air aspiration detection Available

Sample pipetting volumes 15 μL

(serum/plasma/urine) For reruns of urine samples with a decreased sample volume after Test data alarm: 10 μL

Reagent pipetting volumes per sample DIL 780 μL

IS 720 μL

REF 130 μL

* The ISE unit and the c 303 photometric measuring unit share the same sample pipetter
** Throughput may differ based on the mix of test orders per sample
References
1 cobas® pure integrated solutions User Guide – Publication
Ver 1.0 · Draft Ver 3.
2 Elecsys assay menu cobas pure – Analysis (source method
sheets cobas e pack green).
3 cobas pure – AutoCal Estimated Time Savings – Internal
Calculation.
4 cobas pure – footprint dimensions – Internal Document.
5 Elecsys assay menu cobas pure – Analysis (source method
sheets cobas e pack green, CMP Database).
6 Clinical Chemistry assay menu cobas pure – Analysis
(source method sheets cobas c pack green).
7 Roche Diagnostics Internal Reporting Data On File –
GCS reporting / Product reports Q1/2020, CPS Finance
Report from Tableau, ICB Q1 2020.

COBAS, COBAS C, COBAS E and ELECSYS

are trademarks of Roche.

© 2021 Roche Diagnostics

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