cobas b 123 POC systemFocus on what matters

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COBAS, COBAS B, COBAS H, COBAS BGE LINK, COBAS INTEGRA, LIGHTCYCLER, SEPTIFAST, URISYS, ACCU-CHEK, COAGUCHEK, and LIFE NEEDS ANSWERS are trademarks of Roche.

©2013 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com

cobas b 123 POC systemSimplicity

• Smart chip technology – Consumables scan auto-matically and all important information is stored when consumables are exchanged from one analyzer to another

• Consumable change display – Clearly highlighted when consumables are due to expire and how many days or tests are left

• Easy installation – Initial set up of the analyzer is easy to follow, with graphical guidance

• Intuitive graphical user interface – Presents all analyzer status information, in a format which is easy to understand and interact with

• Graphically guided sampling and consumable changes – Allows users to run samples and man-age consumable changes, with minimal training and risk of errors

• 1 & Done – No preventative maintenance. All traditional routine maintenance parts are contained in the fluid pack

• Low training need – With graphical guidance and intuitive workflows, it only takes a few minutes to train new users

cobas b 123 POC system

Simplicity Peace of mind

Flexibility

“The acid-base mapping and patient trending functionality assists the

healthcare professional in making effective decisions on the management

of critically ill patients.”

cobas b 123 POC systemPeace of mind

• Comprehensive clot protection – Eliminating the risk of analyzer downtime, due to clots

• Operator Lock-out – Only trained users are allowed to have access to the instrument, reducing the risk of errors and analyzer downtime

• Levels of access – Certain specially trained users can perform advanced functions on the analyzer. e.g. change consumables, check QC results or manage new users

• No needle exposure, with closed sample port – Reducing the risk of sample spillage and exposure to potentially hazardous waste

• Acid/Base mapping and result trending – Assisting the HCP in making decisions on the progress of the patients’ condition

• Analytical performance – Bringing “lab-like” performance to the point of care to ensure quality of the results in critical care

• Data management – Allowing the laboratory to control the quality and regulatory aspects of BGE testing, remotely

cobas bge link softwareLike standing in front of your blood gas analyzer through screen sharing• Complete remote management, control &

troubleshooting• Multi-site and multi-analyzer management• A single source for viewing all cobas blood gas

analyzer data• User friendly and intuitive• Clear graphical layout

cobas bge link software, cobas IT 1000 application and cobas academyConvenience and efficiency for the management of POC testing• Remote configuration and control of all your connected

POC devices• Only trained users can access and operate the analyzers• Clear overview of all warnings and alerts, at one glance• Result validation and data management • Review QC results + Levey-Jennings plots• Operator certification and re-certification• Secure connection via Axeda allows remote servicing

opportunities

Fulfilling your testing needs no matter where

“With the cobas POC IT solutions package you can easily manage your cobas POC analyzers and all operators from your desk”

Remote Site

Main Site

cobas POC IT solutionscobas IT 1000 applicationcobas bge link softwarecobas academy

Data and control

Roche Hotline cobas e-support

LIS/HIS

Roche POC analyzerse.g.: cobas b 123, cobas b 221 and cobas b 121 POC systemsCoaguChek XS Plus and Pro systemsAccu-Chek Inform II systemUrisys 1100 analyzercobas h 232 POC system

cobas lab IT solutionscobas IT 3000 applicationcobas IT 5000 application

“The flexibility of the cobas b 123 POC system allows it to meet the different testing demands of multiple critical care departments, within the hospital.”

• Different sensor & instrument configurations – Allows flexibility for different sample throughputs and parameter needs

• Compact design – The small footprint means that the analyzer can fit into departments where space is at a premium

• Lit sample area – Ideal for areas with low lighting and to avoid any hazardous sample spillages

• Left-handed – Central enclosed port makes left of right-handed use comfortable and safe

• Mobile cart – Allowing you to take your blood gas and electrolyte testing to where it is needed most

• Compact flash card – Prevents data loss, in the event that an analyzer should crash. Swap the compact flash card and the data is mirrored on the new analyzer

• Transferable consumables – Reducing waste of tests and offering flexibility in inventory management, by swapping consumables between instruments

• Broad parameter panel – Meeting the varying parameter combinations needed by different depart-ments around your hospital

cobas b 123 POC systemFlexibility

Adapting to your needs• With flexible configurations and a throughput of up to 30 samples

per hour the cobas b 123 POC system can be easily customized to the clinical needs in the ICU, ER, NICU, OR, dialysis units and of the laboratory setting

• The full cobas b 123 POC parameter panel includes pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, Hct, Glu, Lac, tHb, SO2, O2Hb, HHb, COHb, MetHb, and bilirubin (tBilirubin). Plus an extensive range of calculated parameters

• Flexibility and scalability allows clinically relevant and cost efficient Point-of-Care testing

• All consumables can be interchanged between cobas b 123 POC systems

• Optional mobile cart, UPS (uninteruptable power source) backup and wireless connectivity enable operation where ever needed

1 BG = pH, pCO2, pO2

2 Electrolytes = Na+, K+, Ca2+, Cl -

3 AutoQC = automatic quality control system

Four sensor configurations:• BG1 + Hct• BG + Hct + Electrolytes2 • BG + Hct + Electrolytes + Glu• BG + Hct + Electrolytes + Glu + Lac

Four instrument configurations:• without AutoQC and COOX• with AutoQC • with COOX• with AutoQC and COOX

Six pack configurations:• Without COOX: 200, 400, or 700 samples• With COOX: 200, 400, or 700 samples

Increase your flexibility1

2

3

1

2

3

cobas b 123 POC systemPeace of mind

All support elements from Roche ensure maximum availability of your analyzersRoche ensures a smooth installation process through thorough preparation• Conduct detailed site survey• Collect IT and connectivity information• Coordinate delivery information• Determine training requirements These preparatory activities allow a timely and efficient installation and immediate operator training.

COBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche.

© 2013 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com

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cobas e-support – immediate troubleshooting via remote accesscobas e-services• Improved analyzer uptime by remote diagnosis and

resolution of many analyzer issues• Additional operator training via remote sessions

Depot service• No on-site visits from service specialists required• Immediate analyzer swap, with no loss of database or configuration data

On-site service• A Roche service specialist visits you on-site

Hotline support• Trained hotline specialists support you in trouble-shooting and application questions

Remote expert screen sharing • Immediate and direct support intervention

Remote software updates• Less interference with departments routine, by electronic

software updates for cobas b 123 POC systems which are connected to Roche

Monitoring system status • Early error detection and proactive service intervention

Trouble shooting reports• A certificate reports the cobas b 123 POC system condition

and assists in determining the root cause of any issue

Please contact your local Roche service organization to receive information about local availability of these service elements.

Elements of support/support options

cobas e-services Remote expert screen sharing

Remote software updates

Monitoring system status

Trouble shooting reports

On-site service

Depot service

Hotline support

Maximizingavailability

cobas b 123 POC systemProduct specifications

Measured parameters

Blood gases Specified rangepH 6.5 – 8.0 pCO2 10 – 150 mmHg (1.33 – 19.95 kPa)pO2 10 – 700 mmHg (1.33 – 93.10 kPa)ElectrolytesNa+ 100 – 200 mmol/LK+ 1 – 15 mmol/LCa2+ 0.1 – 2.5 mmol/L Cl- 70 – 150 mmol/LHct 10 – 75 %MetabolitesLactate 1 – 20 mmol/LGlucose 1 – 30 mmol/LCO-Oximetry(1)

tHb 4 – 25 g/dL (2.5 – 15.5 mmol/L)SO2 30 – 100 %O2Hb 30 – 100 %COHb 0 – 70 %MetHb 0 – 70 %HHb 0 – 70 %Bilirubin (total) 3 – 50 mg/dL (51.3 – 855 μmol/L)

Calculated parameters H+, cHCO3-, ctCO2(P), FO2Hb, BE, BEecf, BB, SO2(1), P50, ctO2,

ctCO2(B), pHst, cHCO3-st, PAO2, AaDO2, a/AO2, avDO2, RI, Shunt,

nCa2+, AG, pHt, H+t, PCO2t, PO2t, PAO2t, AaDO2t, a/AO2t, RIt, Hct(c),

MCHC, BO2, BEact, Osmolality, OER, Heart minute volume (Qt),

P/F index, Lactate clearance

Sample volumeParameter VolumeBG(3), Hct, Electrolytes(4), Glu, Lac, COOX 123 μLBG, Hct, Electrolytes, Glu, Lac 102 μLMicro mode – BG, Hct, COOX 56 – 122 μLMicro mode – BG only 38 – 55 μLMicro mode – COOX only (inc. Bilirubin) 25 – 37 μL

COBAS, COBAS B, LIFE NEEDS ANSWERS and AUTOQC are trademarks of Roche.

© 2013 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com

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Sample types Whole blood, aqueous and blood-based QC solutions, and dialysis solution

Calibration Interval System calibration Every 24 hours 1 point-calibration Every 60 minutes (programmable 30 or 60 minutes) 2 point-calibration Every 12 hours are programmable for 4, 8 or 12 hours Data processing Intel, Celeron M, 800 Hz Monitor Built-in color TFT-LCD 10.4 inch flat screen (touchscreen) Thermal printer Built-in, 111 mm width, graphical capability Supported protocols POCT1-A, ASTM Electrical requirements Power rating 100 – 240 V, 200 W, 50/60 Hz autoselecting Ambient temperature +15 to +32 °C (59 to 89.6°F) Relative humidity, not condensed 15 – 85 % Power cable A local supply required Options CO-Oximeter 512 nm wavelengths AutoQC Automatic QC system with room for 24 QC ampoules Barcode scanner Hand held or benchtop Mobile cart UPS (Uninterruptible power supply) APC BACK-UPs CS 350 VA USB/SERIAL 230 V Wireless capability W-Lan modem recommended Test certificate UL UL3101-1 CE conformity IVD-Directive 98/79/EC (IEC 1010-1 / EN 61010-1 / EN 61010-2-101) Dimension/weight instrument Width 33 cm Height 47 cm Depth 32 cm Weight (without solutions, without AutoQC) 18 kg

1optional / 2scheduled for development / 3BG = pH, pCO2, pO2 / 4Electrolytes = Na+, K+, Ca2+, CI-

PoC lactate monitoring ensures rapid detection of life-threatening conditions for the right decisions at the right timeHigh lactate is a marker of severe physiological stress and risk of death. It represents the metabolic changes accompanying severe tissue stress and hypoperfusion. Contrary to long-standing belief, lactate is not only a marker of hypoxia but also serves as a metabolic signal.2 The lactate level represents a balance between generation and elimination and so should not be interpreted in isolation from oxygen status and blood pH.3 Measurement of blood lactate concentrations is therefore a vital addition to the blood gas analysis process. Rapid and reliable assay results are essential in ensuring that clinicians detect life-threatening conditions on time and make the right treatment decisions without delay. Repeated measurement of blood lactate concentrations at short intervals enable an evaluation of disease progression, prognosis, and response to treatment.

Vital and versatile: Impact of lactate-testing in critical care and emergenciesSepsis & septic shock: According to the international guidelines for management of severe sepsis and septic shock, 2008, sepsis-induced shock is defined as tissue hypoperfusion (hypotension persisting after initial fluid challenge or blood lactate con-centration > 4 mmol/L).4 Blood lactate concentration is an initial parameter for protocolized resuscitation of patients within the first six hours.4 All patients with a lactate level > 4 mmol/L, whatever their blood pressure is, are entered in the early goal-directed therapy portion of the severe sepsis resuscitation bundle.5 It has been shown that blood lactate levels have a greater prognostic value than oxygen-derived variables and that serial lactate levels improve the prognostic value and help guide therapy.6,7

Lactate in critical care and emergenciesFlexibility

Lactate clearance as a key indicator of prognosis in sepsis7

“Lactate measurement has evolved as a routine clinical monitor in critically ill patients. It has been suggested that measurement of blood lactate should be routinely available in critical care settings.” 1

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References 1 Mizok, B.A. (2002). Point-of-Care Testing of Blood Lactate. J Lab Med. 26(1/2), 77-81.2 Levy, B., Gibot, S., Franck, P., Cravoisy, A., Bollaert, P.E. (2005). Relation between

muscle Na+K+ ATPase activity and raised lactate concentrations in septic shock: a prospective study. Lancet. 365 (9462), 871-875.

3 Handy, J. (2006). Lactate – The bad boy of metabolism, or simply misunderstood? Current Anaesthesia & Critical Care. 17, 71-76.

4 Dellinger, R.P., Levy, M.M., Carlet, J.M., Bion, J., Parker, M.M. et al. (2008). Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 36(1), 296-327.

5 Surviving Sepsis Campaign. www.survivingsepsis.org/bundles/individual_changes/ serum_lactate, accessed March 2009.

6 Bakker, J., Coffernils, M., Leon, M., Gris, P., Vincent, J.L. (1991). Blood lactate levels are superior to oxygen derived variables in predicting outcome in human septic shock. Chest. 99, 956-962.

7 Nguyen, H.B., Rivers, E.P., Knoblich, B.P., Jacobsen, G., Muzzin, A. et al. (2004). Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 32(8), 1637-1642.

Cardiac diseases: Elevated lactate levels predict the development of shock in patients with acute myocardial infarction.8 In patients surviving the first 48 hours after cardiac arrest, serial lactate measurements have a high prognostic value for mortality and neurologic outcome.9 Goal-directed therapy (GDT) based on sequential point of care blood lactate measurements 24 hours after congenital heart surgery sig nificantly reduced the mortality in neonates and especially those infants undergoing higher-risk surgeries.10

Circulatory shock: Lactate levels and clearance have been established as a diagnostic, therapeutic and prognostic marker of tissue hypoxia in circulatory shock.11

Trauma: Lactate values correlate with Injury Severity Score and Glasgow Coma Score for trauma patients entering the ED. Admission lactate improves triage assessment in severely injured patients.12,13

Burn injuries: The inability to clear lactate in the first 48 hours of burn resuscitation differs signi ficantly between survivors and non-survivors of burn injuries. According to study data, mortality in burn patients can be reduced by better control of fluid loading in burn resuscitation.14

Lactate on cobas b 123 POC system: Rapid results within 2 minutesLactate testing on a blood gas analyzer at the point of care is a fast, valid and effective method in implementing the recom-mended rapid turnaround times. PoC blood lactate testing with cobas b 123 analyzer is technology for the titration of therapy. Reliable results are available within 2 minutes to the clinician at the bedside, enabling timely alterations in therapy. In addition, the cobas b 123 POC system will calculate the lactate clearance by tracking the hourly change in the percentage of mea-sured lactate.

8 Mavric, Z., Zaputović, L., Zagar, D., Matana, A., Smokvina, D. (1991). Usefulness of blood lactate as a predictor of shock development in acute myocardial infarction. Am J Card. 67, 565–568.

9 Kliegel, A., Losert, H., Sterz, F., Holzer, M., Zeiner, A. et al. (2004). Serial lactate determinations for prediction of outcome after cardiac arrest. Medicine (Balti-more). 83(5), 274-279.

10 Rossi, A.F., Khan, D. (2004). Point of care testing: improving pediatric outcomes. Clin Biochem. 37(6), 456-461.

11 Matejovic, M., Radermacher, P., Fontaine, E. (2007). Lactate in shock: a high-octane fuel for the heart? Intensive Care Med. 33, 406-408.

12 Coats, T.J., Smith, J.E., Lockey, D., Russel, M. (2002). Early Increases in Blood Lactate Following Injury. J. R. Army Med Corps. 148, 140–143.

13 Cerovic, O., Golubovi, V., Spec-Marn, A., Kremzar, B., Vidmar, G. (2003). Relation-ship between injury severity and lactate levels in severely injured patients. Intensive Care Med. 29(8), 1300-1305.

14 Jeng, J.C., Lee, K., Jablonski, K., Jordan, M.H. (1997). Serum Lactate and Base Defi-cit Suggest Inadequate Resuscitation of Patients with Burn Injuries: Application of a Point-of-Care Laboratory Instrument. J Burn Care Rehabil. 18, 402–405.

15 Nichols, J.H. (2006). National Academy of Clinical Biochemistry laboratory medicine practice guidelines: evidence based practice for point of care testing. AACC Press.

COBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche.

© 2013 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerland www.cobas.com

“Overall, the guideline developers recommend that POCT of lactate results be considered as a way to improve outcomes in critical care patients.” 15

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Diagnosis and monitoring of neonatal jaundiceImmediate monitoring of bilirubin in neonatal care lowers the risk of life-threatening conditions and lasting harm. More than 50 % of mature healthy newborns develop hyperbilirubinemia. In rare cases, blood bilirubin concentrations above a critical value result in kernicterus (encephalopathy), which causes death in 10 % and long-term morbidity in 70 % of cases.2 Whether and when a child receives phototherapy or blood exchange to eliminate neurotoxins and prevent irreversible brain damage and neurological development deficits crucially depends on total serum bilirubin (TSB) and age. The current guidelines have been developed by the American Academy of Pediatrics (AAP), representing a consensus of the AAP subcommittee on hyper-bilirubinemia to update the existing guideline based on a careful review of the evidence by the New England Medical Center Evidence-Based Practice Center.3

Bilirubin in neonatal care Flexibility

• Use total bilirubin. Do not substract direct reacting or conju-gated bilirubin

• Risk factors = isoimmune hemolytic disease, G6PD deficiency, asphyxia, significant lethargy, temperature instability, sepsis, acidosis, or albumin < 3.0 g/dL (if measured)

Guideline recommendations for phototherapy in hospitalized infants of 35 or more weeks’ gestation3

“We need to assess jaundice risks the way we assess other risks.” 1

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Infants at lower risk (38 weeks, and well)Infants at medium risk (38 weeks + risk factors or 35 – 37 week, and well)Infants at higher risk (35 – 37 week + risk factors)

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• For healthy infants at 35 – 37 weeks after birth one can adjust TSB levels for inter vention around the medium risk line

• It is an option to intervene at lower TSB levels for infants closer to 35 weeks and at higher TSB levels for those closer to 37 weeks

Bilirubin on cobas b 123 POC systemHuge benefit out of a small sample Bilirubin testing on a blood gas analyzer at the POC is a fast, valid and effective method in implementing the guideline recommendations. 25 µL of whole blood of whole blood is all the cobas b 123 POC analyzer needs to deliver reliable results, within 2 minutes. This small sample volume means signifi-cantly less harm to the newborn. The method is also suitable for monitoring borderline elevated bilirubin levels and treatment response in severe hyperbilirubinemia.

“Give physicians the tools to implement the guidelines: Risk assessment tool at bedside.” 1

COBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche.

© 2013 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com

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The authors of an AAP technical report conclude high TSB levels exceeding 20 mg/dL to cause kernicterus, with an increas-ing probability when TSB levels are ≥ 30 mg/dL.2,4 Unknown is the variable susceptibility of infants.5 According to the guide-lines of the AAP, infants with a TSB level of 25 mg/dL or higher at any time should be admitted immediately and directly to a hospital pediatric service for intensive phototherapy.3 To identify and treat endangered children promptly, all neonates need to be monitored. The AAP also recommends a systematic approach to the prevention of severe hyperbilirubinemia and kernicterus, and advocates the establishment of standing protocols for nursing assessment of jaundice which encompass TSB testing.3

References 1 AAP 2008. www.aap.org/qualityimprovement/quiin/shb/hyperbili.pdf,

accessed March 2009.2 Ip, S., Chung, M., Kulig, J., O’Brien, R., Sege, R. et al. (2004). American

Academy of Pediatrics, Technical Report, An Evidence-Based Review of Important Issues Concerning Neonatal Hyperbilirubinemia. Pediatrics. 114, e130-e153.

3 Maisels, M.J., Baltz, R.D., Bhutani, V.K., Newman, T.B., Palmer, H. et al. (2004). American Academy of Pediatrics, Clinical Practice Guideline, Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics 114(1), 297-316.

4 Newman, T.B., Liljestrand, P., Jeremy, R.J., Ferriero, D.M., Wu, Y.W. et al. (2006). Outcomes among Newborns with Total Serum Bilirubin Levels of 25 mg per Deciliter or More. N Engl J Med. 354, 1889-1900.

5 Canadian Paediatric Society. (2007). Guidelines for detection, manage-ment and prevention of hyperbili rubinemia in term and late preterm newborn infants (35 or more weeks’ gestation). Paediatr Child Health. 12 (suppl. B), 1B-12B.

“The best available method for predicting severe hyperbilirubin emia appears to be the use of a timed TSB measurement analyzed in the context of the in fant’s gestational age.” 5