Focus on what matters

cobas b 123 POC system
Focus on what matters
©2010 Roche
Roche Diagnostics 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
cobas b 123 POC system
Simplicity, easy as 1, 2, 3
Graphically guided user interactions
•All major user workflows are supported by graphics
•Step through guide to performing a measurement
•Step through guides to exchanging consumables
Added Clinical Value
Peace of Mind
Maximise Uptime
Simplicity
Mobility
Easy handling steps
•On-board training for all handling steps within minutes
•Accepts all common types of sample containers with out adaptor
•Smart chips on the instrument consumables eliminate
the need for scanning barcodes
Everything at one glance
•Complete overview as to operational readiness
•All relevant information about the consumable status
•Select your preferred parameter panel with only one
button
Straightforward sample introduction
•Immediately initiate a measurement by selecting your
sample container
•Lit sample area simplifies the sample delivery in
low-light settings
•Protected sample input area reduces risk of
contamination
cobas b 123 POC system
Peace of mind, easy as 1, 2, 3
cobas bge link software
Like standing in front of your blood gas analyzer
through screen sharing
•A single data concentrator source for all cobas blood
gas analyzers
•User friendly and self-explanatory
•Clear graphical layout
•Complete remote management and control
•Multisite and multianalyzer management
•Remote troubleshooting
•Proactive management of all analyzers
With the cobas POC IT solutions
package you can easily manage
your cobas POC analyzers and
all operators from your desk
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
cobas lab analyzer series
e.g.: cobas 4000 and 6000 analyzer series
cobas 8000 modular analyzer series
COBAS INTEGRA 400 and 800 analyzers
Lightcycler 2.0 instrument
LIS/HIS
Remote Site
cobas bge link software and cobas IT 1000 application
Convenience and efficiency for the management of POC
testing
•Remote configuration and control of all your connected
POC devices
•Ensure only trained users can operate the analyzers
•Warnings and alerts at one glance
•Validation of measurement results
•Comprehensive data management
•Measurement results
•QC results + Levey-Jennings plot
•Operator certification
•Secure connection via Axeda allows remote servicing opportunities
3rd party
instruments
Roche POC analyzers
e.g.: cobas b 123 POC, cobas b 221 and
cobas b 121 blood gas analyzers
CoaguChek XS Plus
Accu-Chek Inform II
Urisys 1100
cobas h 232 system
Roche Hotline
cobas e-support
cobas lab IT solutions
cobas IT 3000 application
cobas IT 5000 application
cobas b 123 POC system
Mobility, easy as 1, 2, 3
1
3
2
1
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
2
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
3
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
1 2 •Flexibility and scalability allows clinically relevant and cost
­efficient Point-of-Care testing
•All consumables can be interchanged between cobas b 123 POC
systems up to a maximum of ten times.
•Optional mobile cart, UPS (uninteruptable power source) backup
and wireless connectivity enable operation where ever needed
Increase your flexibility
Bilirubin in neonatal care
Added clinical value
Diagnosis and monitoring of neonatal jaundice
Immediate 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 hyperbilirubinemia to update the existing guideline based on a careful review of the evidence by the New England Medical Center
Evidence-Based Practice Center.3
“We need to assess jaundice risks the way we assess other risks.” 1
Guideline recommendations for phototherapy in hospitalized infants of 35 or more weeks’ gestation3
25
428
20
342
15
257
10
171
5
85
0
µmol/L
Total serum bilirubin (mg/dL)
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)
0
Birth
24 hours
48 hours
72 hours
96 hours
5 days
6 days
7 days
Age
• Use total bilirubin. Do not substract direct reacting or conjugated bilirubin.
• Risk factors = isoimmune hemolytic disease, G6PD deficiency,
asphyxia, significant lethargy, temperature instability, sepsis,
acidosis, or albumin < 3.0 g/dL (if measured)
• For healthy infants at 35-37 weeks after birth one can adjust
TSB levels for inter­vention 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.
The authors of an AAP technical report conclude high TSB levels exceeding 20 mg/dL to cause kernicterus with an increasing
probability when TSB levels are ≥ 30 mg/dL.2,4 Unknown is the variable susceptibility of infants.5 According to the guidelines
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
“The best available method for predicting severe hyperbilirubin­emia
appears to be the use of a timed TSB measurement analyzed in the
context of the in­fant’s gestational age.” 5
“Give physicians the tools to implement the guidelines: Risk assessment tool at bedside.” 1
Bilirubin on cobas b 123 POC system
Huge 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. 40-70 µL (micro mode*) of whole blood is all
the cobas b 123 POC analyzer needs to deliver reliable results
within 2 minutes. This small sample volume means significantly less harm to the newborn. The method is also suitable
for monitoring borderline elevated bilirubin levels
and treatment response in severe hyperbilirubinemia.
* in development
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, management and prevention of hyperbili­rubinemia in term and late preterm
newborn infants (35 or more weeks’ gestation). Paediatr Child Health. 12
(suppl. B), 1B-12B.
COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
Roche Diagnostics Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com
06265901001
© 2010 Roche
Lactate in critical care and emergencies
Added clinical value
PoC lactate monitoring ensures rapid detection of life-threatening conditions for the right decisions on 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 lifethreatening 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 as a key parameter: prognosis in sepsis7
Lactate clearance ≥10%
Lactate clearance <10%
Probability of survival
1.0
0.8
0.6
0.4
0.2
0.0
0
10
20
30
Days
40
50
60
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 sig­nificantly reduced the mortality in neonates and especially those infants undergoing higher-risk s­ urgeries.10
Circulatory shock: Lactate levels and clearance have been established as a diagnostic, therapeutic and p
­ rognostic 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 signi­ficantly 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 minutes
Lactate testing on a blood gas analyzer at the point of care is a fast, valid and effective method in implementing the recommended 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.
“Overall, the guideline developers recommend that POCT of lactate
results be considered as a way to improve outcomes in critical care
patients.” 15
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.
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 (Baltimore).
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 highoctane 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). Relationship 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 Deficit 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.
© 2010 Roche
Roche Diagnostics Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com
06265901001
COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of 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, BE ecf, 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 , BE act , Osmolality, OER, Heart minute volume (Q t),
P/F index
Sample volume
Parameter
Volume
BG(3) + Hct + Electrolytes (4) + Glu + Lac + COOX 123μL
BG + Hct + Electrolytes + Glu + Lac
102μL
Micro Mode(2) full menu
70μL
(2)
Micro Mode full menu without COOX 40μL
Sample types
Whole blood, aqueous and blood-based QC
solutions, plural fluids* and dialysate*
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
CE conformity UL3101-1
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)
33 cm
47 cm
32 cm
18 kg
1
-
optional / 2 scheduled for development / 3 BG = pH, pCO2, pO2 / 4 Electrolytes = Na+, K+, Ca2+, CI / * in development
© 2010 Roche
Roche Diagnostics Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com
06265901001
COBAS, COBAS B, LIFE NEEDS ANSWERS
and AUTOQC are trademarks of Roche.
cobas b 123 POC system
Maximizing uptime, easy as 1, 2, 3
All Roche support elements ensure
maximum availability of your analyzer
systems
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 resolving
analyzer issues
• Additional operator training with remote sessions
Hotline support
• Trained hotline specialists support you in ­trouble-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 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
COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
Roche Diagnostics Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com
06265901001
© 2010 Roche