cobas b 123 POC system Focus on what matters

©2013 Roche Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.cobas.com

06265901001

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

cobas b 123 POC system

Simplicity

Flexibility

cobas b 123 POC system Simplicity

Peace of mind

• 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 manage consumable changes, with minimal training and risk of errors • 1 & Done – No preventative maintenance. All ­t raditional 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 • Smart chip technology – Consumables scan automatically 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

cobas b 123 POC system Peace of mind

“The acid-base mapping and patient trending functionality assists the healthcare professional in making effective decisions on the management of critically ill patients.”

• 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

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

cobas bge link software Like 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

Fulfilling your testing needs no matter where Main Site

cobas POC IT solutions cobas IT 1000 application cobas bge link software cobas academy

Data and control

LIS/HIS

Remote Site

cobas bge link software, cobas IT 1000 ­application and cobas academy Convenience 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

Roche POC analyzers e.g.: cobas b 123, cobas b 221 and cobas b 121 POC systems CoaguChek XS Plus and Pro systems Accu-Chek Inform II system Urisys 1100 analyzer cobas h 232 POC system

Roche Hotline cobas e-support

cobas lab IT solutions cobas IT 3000 application cobas IT 5000 application

cobas b 123 POC system Flexibility

• 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 departments around your 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

“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.”

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

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

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

• 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

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

BG = pH, pCO2, pO2 Electrolytes = Na+, K+, Ca2+, Cl 3  AutoQC = automatic quality control system

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• 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

Increase your flexibility

cobas b 123 POC system Peace of mind All support elements from Roche ensure maximum availability of your analyzers Roche 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.

Elements of support /support options

cobas e-services

Remote expert screen sharing

Depot service

Remote software updates Maximizing availability

On-site service

Monitoring system status

Hotline support

Trouble shooting reports

Please contact your local Roche service organization to receive information about local availability of these service elements. cobas e-support – immediate troubleshooting via remote access cobas e-services • Improved analyzer uptime by remote diagnosis and resolution of many analyzer issues • Additional operator training via remote sessions

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

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

Remote software updates • Less interference with departments routine, by electronic software updates for cobas b 123 POC systems which are connected to Roche

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

Monitoring system status • Early error detection and proactive service intervention

Remote expert screen sharing • Immediate and direct support intervention

Trouble shooting reports • A certificate reports the cobas b 123 POC system condition and assists in determining the root cause of any issue

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

Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.cobas.com

06265901001

© 2013 Roche

cobas b 123 POC system Product specifications Measured parameters Blood gases pH pCO2 pO2 Electrolytes Na+ K + Ca2+ Cl- Hct Metabolites Lactate Glucose CO-Oximetry (1) tHb SO2 O2Hb COHb MetHb HHb Bilirubin (total)

Specified range 6.5 – 8.0 10 – 150 mmHg (1.33 – 19.95 kPa) 10 – 700 mmHg (1.33 – 93.10 kPa) 100 – 200 mmol/L 1 – 15 mmol/L 0.1 – 2.5 mmol/L 70 – 150 mmol/L 10 – 75 % 1 – 20 mmol/L 1 – 30 mmol/L 4 – 25 g/dL (2.5 – 15.5 mmol/L) 30 – 100 % 30 – 100 % 0 – 70 % 0 – 70 % 0 – 70 % 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 (Q t), P/F index, Lactate clearance

Sample volume Parameter BG(3), Hct, Electrolytes(4), Glu, Lac, COOX BG, Hct, Electrolytes, Glu, Lac Micro mode – BG, Hct, COOX Micro mode – BG only Micro mode – COOX only (inc. Bilirubin)

Volume 123 μL 102 μL 56 – 122 μL 38 – 55 μL 25 – 37 μL

Sample types

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

Calibration System calibration 1 point-calibration 2 point-calibration

Interval Every 24 hours Every 60 minutes (programmable 30 or 60 minutes) Every 12 hours are programmable for 4, 8 or 12 hours

Data processing Monitor Thermal printer Supported protocols

Intel, Celeron M, 800 Hz Built-in color TFT-LCD 10.4 inch flat screen (touchscreen) Built-in, 111 mm width, graphical capability POCT1-A, ASTM

Electrical requirements Power rating Ambient temperature Relative humidity, not condensed Power cable

100 – 240 V, 200 W, 50/60 Hz autoselecting +15 to +32 °C (59 to 89.6°F) 15 – 85 % 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 Height Depth Weight (without solutions, without AutoQC) 1

33 cm 47 cm 32 cm 18 kg

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

© 2013 Roche Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.cobas.com

06265901001

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

Lactate in critical care and emergencies Flexibility PoC lactate monitoring ensures rapid detection of life-threatening conditions for the right decisions at the right time High 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.

“Lactate measurement has evolved as a routine clinical monitor in critically ill patients. It has been s­ uggested that measurement of blood ­lactate should be routinely available in critical care settings.” 1 Vital and versatile: Impact of lactate-testing in critical care and emergencies Sepsis & 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 concentration > 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 clearance as a key indicator of prognosis in sepsis7 Lactate clearance ≥10 % Lactate clearance