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Roche OPTI R Analyzer

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5. Sample Data Regression Identity OMNI Correlation number of pairs n 178 slope m 0 7661 y intercept b 0 270 y intercept normalized 0 0124 regression coefficient r 0 86734 correlation coefficient 0 93131 std error of y estimate 0 0343 average difference 0 008 SD of differences 0 043 two tail 0 47 OPTI R Analyzer Correlation to Predicate Methods OPTIR vs OMNI ctHb OPTI Sample Data Regression Identity OMNI Correlation number of pairs n 178 slope m 0 97057 y intercept b 0 4077 y intercept normalized 0 0250 regression coefficient I 0 97456 correlation coefficient r 0 98720 std error of y estimate 0 3373 average difference 0 077 SD of differences 0 342 lt two tail 0 73 OPTI R Analyzer Correlation to Predicate Methods OPTIR vs Calculated SO2 SO2 vs SO2c 100 95 90 85 80 75 70 Sample Data Regression Identity 60 60 65 70 75 80 85 90 95 100 OMNI Correlation number of pairs n 178 slope m 1 05462 y intercept b 5 1927 y intercept normalized 0 277 regression coefficient r 0 944 correlation coefficient r 0 971 std error of y estimate 1 354 average difference 178 000 SD of differences 0 052 P T lt t two tail 0 93 Rhe OPTR 8 2 Conducting A Field Test Corre
6. pue 5 eyesseo uo Paesu adh 19109 SSeJd M3IN3 sseiduuguoo oL JHLZ xxeo3 edAL 107 9 7 wuyuoo ejduies yore 069 529 EG oed SNLYLS MAU oj eins eg 3 LON sis bue e uw b cH ejnuiu euo auno s le Se 15281 pue pue pue spuey jo seg y ueeweq eui pue J9ju3 88914 XXXXXXXXXX at do se qqnq seb jo s ejduies eui ens 9xejw 3 LON lt nue eidues peuinbe 41 01 dO 40144 uny IEOIX9N Lc ACVAY uo sajdwes Zu 88014 TRAE OOE eidureg ubu 88914 5 VANG ooy AG VH IEOX N Z SNLVLS AGV4Y 2 140 10404009 sejduies buluuny suse sss 6 6 2 Internal Memory Functions The OPTI R Analyzer has the following
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8. FOL xoiddy 09 xoiddy oui srsA euy suonnjog snoanby suonnjog siogng snoonby suonnjog snoonby ojesAqerq euseda euise d euise d poo q POOTd poo q poo q POOTd PPM addy 11002 SZI TlocT 69 11001 xouddy 1 Tiset 1100 111 8 5 TOET 9 Tios 1 TiszI 9215 o dureg org ssoon D qH org PH PH PLT asoonyy oreq Os qH pH oreg 205 qH 480 M EN 80 M PN ID e 5M EN M PN M 480 sA EN 80 M PN Od Hd HA OOd Hd Od HA 04 Hd Od ODd Hd OOd Hd 598 0006 51114 LVIS uoi VOOD Trud W9 TI food WIS TI n 2 Y 01 510 9 177 esf 40 siazAjeuy ZZ 922 0002 99304 neuioiny Aqyn 4 4 Aqyn 4 4 4 4 4 uoneiqipe SOR SOR SOR SOR SOR SOR SO
9. aboratory Director Coordinator if applicable Chemistry Supervisor SSCS A Tsas Clinical Interest The laboratory serves the units mentioned before Their main purpose is to provide the critical care sites with accurate and precise results based on the analytes parameters ordered The lab knows the different analytical methods and their limitations from a analytical perspective In most cases the lab is responsible for quality of results and therefore for QC In most cases the lab holds the license to do critical care testing Therefore most of the POCT is done under the license and responsibility of the lab The lab plays in many cases a supervisor role for POCT The POC coordinator is mostly a lab person Main Parameters Needed The laboratory has the potential to provide all parameters asked for in a hospital not only critical care parameters Critical issues for the user Analytical performance accuracy and precision and correlation to lab system daily QC user training cost per test sample throughput reliability and robustness of the system as well as data integration with the LIS HIS system are the main concerns of the lab Less Critical Ease of use size weight portability battery operation Typical sample throughput 20 250 per day Important OPTI R features to highlight e Analytical performance correlation e 6 pt factory calibration 1 pt on board buffer gas calibration e
10. variation within the range 100 180 mmol L The OPTI sensor has no measurable interference from variation within the range 0 8 10 mmol L The OPTI sensor does exhibit a small interference from Li 147 levels of 1 2 5 6 4 mmol L will cause a positive bias of 0 9 1 2 and 1 3 mmol L respectively A syringe sample anticoagulated with typical amounts of lithium heparin has 1 4 mmol L of lithium which offsets the measured Na by less than 196 To minimize the interference from lithium use syringes containing the lowest acceptable heparin level or a balanced heparin type syringe Carefully follow the syringe manufacturer s recommendation regarding proper filling of the syringe A partially filled syringe results in excessive lithium concentration Heparin salts are the only acceptable anticoagulant Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte and pH sensors The OPTI and results include an appropriate correction for pH at all values of pH This correction may introduce an extra source of variability at the extreme values The OPTI Ca sensor does exhibit an interference from bisulfate and phenylacetic acid Selected substances endogenous and exogenous to human blood were tested for interference in accord with NCCLS 7 These substances were selected on the basis of their optical absorbance or fluorescence propertie
11. ENTER to display the second set of results with their associated calculated parameters Ca tCo2 156 4 5 82 1 24 22 1 9 Press ENTER again to display the third set of results and calculated parameters PO2 tHb SO2 Hct 1454 9 15 2 99 5 556 NOTE Theresolution of the measured parameters may be configured 156 4 mmol L or LOW Na 156 mmol L in the setup menu See the OPTI R Operator s Manual for configuration under setup NOTE The OPTI R Analyzer flags values that are above or below the programmed ranges with an up or down arrow If the value is outside the measurable range a High or Low will be displayed and a gt or lt with a range printed out on the patient report For Ready press lt ESC gt Edit Pat Data lt ENTER gt 10 Press 5 to go to the next sample To edit the patient data press ENTER If the wash cycle is not finished yet a short Please Wait will be displayed before returning to READY NOTE For minimal keystrokes press ESC when the first results are displayed NOTE The printout will automatically start when the first results are displayed This feature Printing the Report may be turned off in setup See the OPTI R Operator s manual for configuration under Setup READY 18Remain 30NextCal 1 Sample 2 QC 3 Menu gt
12. Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulminary Bypass 1 26 g dL 1 260 mg dL 1 16 mmol L 29 0 37 0 RmAir Mask T P NC Vent Bag Hood Other Where RmaAir Room Air Mask MAsk T P T Piece NC Nasal Canula Vent Ventilator Bag Bag manual resuscitation Hood Hood Other Other 0 21 1 0 1 16 g dL 0 70 2 00 15 40 mmHg 2 0 5 3 kPa Roche OPTR Input Values Vent Mode Tidal Volume TVol VT Minute Volume MVol VE Peak Inspiratory Pressure PIP Plateau Pressure Pplat Pressure Support Value PS Positive End Expiratory Pressure PEEP Continuous Positive Airway Pressure CPAP Rate f Flow Rate Liter Flow FR Inspiratory Expiratory Ratio I E Ratio BiLevel Pressure User Defined Field No SIMV PSV PCV CMV AC CPAP PCIVR BIPAP Where No None SIMV Syncronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure 0 4000 0 120 0 140 0 100 0 99 9 0 50 0 50 0 155 000 00 300 00 0 2 9 9 0 2 9 9 0 9 9 0 9 9 cmH O Blank to 999999 6 6 4 Peripheral equipment optional 6 6 4 1 Battery Charger 110volts For fast chargi
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14. q m su amp eqinoiuud ssvd 288 9101 9025 286 6 966 mog S IB 1913 88914 ZOS 204 88014 205 qH 204 juabeay enesse SSVd 16 977 882 221 ler seoeyns Jeyu3 88014 1891 480 4M EN ZOO 489 eN sv SSVd 910 Oty 2072 Ve 966 99 6622 suod OWS 1919 88814 pue 204 4 29109 889 4 38 204 024 eoejdes Sujuo 9 ejeq 1uened H3INd sSseid ejeqed XXX jndui 0 1ejue indui o4 Buunsee u 34 qH 8891 lt 4 1 gt neJqi 88014 1 3 0300 4 Bunge 1 d do pue sug ondo OWS Buunseey Buunseayy ajdwes uee 2 eseeld HEM eseeld pjeeM 1 Bungeiidsy J9 U3 SseJd lt YaLNa gt 88014 pue J9 U3 SS8Jg H3LIN3 SseJd aed 2 eu
15. Typical Audience Operators e Nursing Staff e Physicians Clinical Interest Analysis of critical care parameters are needed to find a diagnosis Emergency patients can be categorized into three groups the ones who do well and need no test the ones who are obviously sick and need ABG tHb and Glucose And last the ones who are not clearly in either group needing a lot of different tests for diagnosis Analysis of critical analytes are indicated if patients are unconscious or appear to have respiratory problems heavy breathing obstruction or trauma of airways pale or blue skin and or with cardiac problems chest pain arrythmia low pulse etc Main Parameters Needed PO2 tHb SO to determine tissue oxygenation oxygen transport function tHb indicator for blood loss blood transfusions pH PCO2 to determine the acid base balance K water balance kidney function nerve and muscle function Glucose Test for diabetes Critical issues for the user Turn around time for making a critical decision ease of use training requirement system robustness accuracy and precision of results low maintenance incl blood clotting QC issues no time for QC portability Less Critical Sample volume cost Typical sample throughput Varies between 3 15 per day depending on size of department Important OPTI R features to highlight e Ease of use i e automatic sample aspiration no user inte
16. e 9 9 999 9 04 addy 88 2 sodAT 88 282 0002 421e W 99304 Rhe OPTR Strengths e Market Acceptance POCT pioneer e Menu Wide menu available e Size Many like the small cell phone look e Abbott Alliance This gives new clout and increased coverage e On Board QC Electronic QC integrated into system No need to run separate electronic QC Weaknesses e Refrigeration of Cassettes Required Cassettes good for 6 months in refrigerator Two weeks out of refrigerator at room temp e Four Hour Equilibration Time Cassettes require this time before they can be used when brought out of the refrigerator or fifteen 15 minutes for individual blood gas cassettes e Immediate Use of Cassette Required Once pouch is opened cassette must be used immediately e Limited On Board Data Management Stores only 50 patients and two weeks of QC No QC Lock Out Operators risk running samples on analyzers that have failed QC e Introduction of Sample Sample must be filled to fill mark upon introduction can result in under or overfilling of cassette Increases training time required Calculated Thb and 02 Saturation Directly measures HCT via conductivity which can be problematic in OR settings e Temperature Sensitivity in OR Environment Unable to maintain ambient temperature in the cool OR suites Begun provi
17. e Ease of Sampling Barcode Reader Ability to enter patient data e Fast Analysis Time Approximately 1 minute from sample introduction e Last Patient Recall Eliminates the need for entering patient id and demographic information more than one time during the case e Wide Ambient Temperature Range Easily accommodates all OR temperature needs e tHb and 02 Saturation Measurement Directly measured tHb might reduce unnecessary transfusions as opposed to HCT measured through conductivity plasma expanders on HCT e Data Storage on the OPTI Lab will be assured that all regulatory requirements are being met Perfusionists and other O R staff aren t concerned with CLIA however this will help appease what ever group holds the license e Transportability to Central Area for Data Download or QC Convenient to take to a central repository area where they can be easily dropped off and picked up ready to go the next day 5 10 2 Intensive Care Unit Coronary Care Unit Typical Audience Operators Nurse Manager Respiratory Care Practitioners ICU Physicians Medical Director SSCS 2000 Tsas Clinical Interest Typical application of critical care analysis is the monitoring of a patient in critical condition or recovery after an event i e after surgery or trauma like burn Main goal is to stabilize and ultimately to facilitate an improvement of the patients respiration cardiac and renal function i e get him her off a ven
18. polymers and specialty chemicals group based in Leverkusen Germany Bayer Corporation is the name of the Bayer Group s U S operations Critical Care Diagnostics Critical Care diagnostic testing includes routine and time sensitive testing for critically ill patients in a variety of areas including pH blood gases electrolytes metabolites CO oximetry and coagulation Physicians are requesting a wider array of blood tests to obtain the information they need to understand a patient s situation and make decisions about diagnosis monitoring and treatment quickly Accordingly demand is rising for a cost effective and reliable instrument that can be managed by the lab and also operated in close proximity to the patient Integrated and networked by Rapidlink Bayer is providing that technology delivering results in seconds to hospital laboratories critical and intensive care units operating rooms emergency rooms and the patient s bedside Rapidpoint 400 Not Released The Rapidpoint 400 is a sophisticated whole blood analysis system that is designed specifically for point of care testing while also satisfying the stringent requirements of the central laboratory A single multiple use measurement cartridge contains all of the components of a traditional laboratory analyzer This long lasting cartridge includes the sampling unit all of the sensors and all calibrating reagents No gas tanks are required A wash wast
19. 0 1 mmol L 0 8 to 10 mmol L 0 01 mmol L 0 2 to 3 0 mmol L 0 01 mmol L 5 to 25 g dL 0 1 g dL 60 to 100 96 0 1 96 300 to 800 mmHg 1 0 to 200 0 mmol L 40 to 40 mmol L 40 to 40 mmol L 40 to 40 mmol L 0 0 to 100 0 mmol L 1 0 to 200 0 mmol L 1 0 to 200 0 mmol L 6 500 to 8 000 0 0 to 100 096 0 0 to 56 0 mL dL 15 to 7596 10 0 to 1000 0 mmol L 0 0 to 800 0 mmHg 15 0 to 35 0 mmHg 0 1 to 3 0 mmol L 125uL Whole blood serum plasma aqueous for QC Syringe Capillary or Microsampler Automatic aspiration Approximately 1 minute from sample aspiration 10 C 30 C 50 F 86 F 5 95 non condensing optical fluorescence for tHb SO2 optical absorbance reflectance Input Values Operator identification number Patient identification number Accession number Patient temperature Patient sex Hemoglobin type Puncture site Bypass Sample type total hemoglobin tHb Mean corpuscular hemoglobin concentration MCHC O2 Mode FIO2 Hemoglobin tHb respiratory quotient RQ P50 sss Blank to 9999999999 Blank to 999999999999999 Blank to 99999999999 14 C 44 C 58 F 111 F male female or adult fetal LR RR LB RB LF RF Cord Scalp Where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right Femoral Cord Cord Scalp Scalp Off Pump On Pump Art Ven MixVen Cap Cord CPB Where Art Arterial
20. 150 200 250 300 OMNI Correlation number of pairs n 178 slope m 0 8984 y intercept b 4 9257 y intercept normalized 4 2219 regression coefficient r 0 99343 correlation coefficient r 0 99671 std error of y estimate 3 7942 average difference 5 034 SD of differences 6 48 Tess Analyzer Correlation to Predicate Methods OPTIR vs OMNI Na 170 160 150 OPTI R 140 130 Sample Data 120 Regression Identity 110 110 120 130 140 150 160 170 OMNI Correlation number of pairs n 178 slope m 1 07284 y intercept b 9 804 y intercept normalized 0 3937 regression coefficient 2 0 89572 correlation coefficient r 0 94642 std error of y estimate 2 2593 average difference 0 383 SD of differences 2 297 P T lt t two tail 0 58 Analyzer Correlation to Predicate Methods OPTI R vs OMNI Sample Data Regression Identity 2 2 3 4 5 6 7 8 OMNI Correlation number of pairs n 178 slope m 0 9789 y intercept b 0 103 y intercept normalized 0 1869 regression coefficient 0 97406 correlation coefficient r 0 98694 std error of y estimate 0 1097 average difference 0 195 SD of differences 0 110 P T lt t two tail 0 01 AS Analyzer Correlation to Predicate Methods OPTIR vs OMNI 1
21. Accepted arterial oxygen tension at sea level while breathing room air Adult and Child Normal 97 mmHg Acceptable range gt 80 mmHg Hypoxemia 80 mmHg New born Acceptable range 40 70 mmHg Aged Acceptable range 60 years old 80 mmHg 70 years old 70 mmHg 80 years old gt 60 mmHg 90 years old gt 50 mmHg Each laboratory should establish its own reference interval for pH PCO and PO as performed on the Roche OPTI R Analyzer as factors such as altitude can affect such measurements 3 2 4 Sodium Sodium is the major cation of extracellular fluid Its primary functions in the body are to chemically maintain osmotic pressure and acid base balance and to transmit nerve impulses Sodium functions at the cell membrane level by creating an electrical potential between different cell membranes causing the transmission of nerve impulses and neuromuscular excitability to be maintained Sodium is involved in some enzyme catalyzed reactions as a cofactor The body has a strong tendency to maintain a total base content and only slight changes are found even under pathologic conditions Low sodium values hyponatremia usually reflect a relative excess of body water rather than a low total body sodium Reduced sodium levels may be associated with low sodium intake sodium losses due to vomiting or diarrhoea with adequate water and inadequate salt replacement diuretics 2 Kaplan LA Pesce AJ Clinical Chemistry Theory analysis an
22. Low identified by vomiting diarrhea cirrhosis Diabetes insulin therapy 4 10 4 lonized Calcium Ca onized Calcium Ionized Calcium is the best indicator of calcium status in the human body Bone Mineralization Neuromuscular excitability and contractility Blood coagulation Total Calcium 50 is Ionized free or unbound calcium calcium binds to protein e Normalized Calcium Calcium that has been adjusted to accommodate pre analytical specimen issues degradation of the sample High Ca can lead to kidney failure and tumors Low caused by major surgery trauma or severe burns 5 Marketing Background 5 1 Premise With the availability of the Roche OPTI R Critical Care Analyzer Roche will be able to provide a complete portfolio of products to meet the needs of our Hospital Point of Care customers 5 2 The Concept The Roche strategy is to be the number one supplier of Hospital Point of Care solutions combining a broad portfolio of analyzers for blood gases electrolytes coagulation troponin measurements and the connection IT solutions These Hospital Point of Care tests help you to cope even more effectively with all the challenges waiting to confront you in Emergency Intensive Care units and Operating Rooms Currently Roche offers the Roche OPTI Critical Care Analyzer CCA with single use cassettes for POCT users with low to medium sample through
23. QC 3 Menu gt 1 Press 1 to start the patient measurement sequence Mix and place the XXX Sample Press ENTER 2 The display will then prompt you to mix and place the sample Mix the syringe sample will by rolling it between the palms of your hands and inverting end over end NOTE Sedimentation of blood cells causes alteration of tHb values Therefore mix the sample well just prior to analysis 3 Using a capillary a syringe and adapter or an Roche Microsampler attach the sample to the cassette fillport and press ENTER The sample 18 then aspirated The sample is then measured During the measurement the status light is blinking and a countdown of the measuring time remaining is displayed in the right hand corner of the screen Aspirating Sample Please Wait Measuring Sample NOTE When sampling from syringes always use a new syringe adapter NOTE If using a syringe make sure the syringe adapter is not touching the syringe adapter e A Attach Capillary Sample Attach Syringe Sample 4 Remove the sample when prompted and press ENTER Measuring Sample XXX Remove Sample ENTER NOTE Failure to remove the sample may cause wash errors 5 To enter patient information press ENTER when this display appears You will then be prompted through entering patient demographic information which has been selected under SETUP See the OPTI R Operator s Manual for complete list of pat
24. STAT Corporation and Abbott Laboratories entered into a strategic alliance that includes a worldwide distribution agreement for i STAT s products in the professionally attended human healthcare market The alliance with Abbott also includes collaboration in the development of new products as well as an equity ownership position in the Company Except in Japan the i STAT System is sold exclusively by Abbott In Japan the i STAT System is marketed on a nonexclusive basis by both FUSO Pharmaceutical Industries and Dainabot Co Ltd Abbott s Japanese affiliate OPTR The Company has a license agreement with Agilent Technologies a Hewlett Packard subsidiary which provides for the integration of i STAT technology into patient monitors In 1997 Hewlett Packard launched the HP Blood Analysis Module which uses 1 STAT cartridges to perform blood analysis with HP s market leading Omnicare Component Monitoring System HP markets the Blood Analysis Module worldwide Heska Corporation is the exclusive worldwide distributor of the i STAT System to the veterinary market Organization amp Facilities i STAT Corporation currently operates two facilities and employs approximately 600 people A diverse Company staff includes manufacturing personnel process engineers research and development scientists and engineers mechanical electrical and chemical a software engineering and development group a technical clinical services organization a qual
25. appropriate FE color electrons in the molecules of the fluorescent chemical are excited very short time later the electrons return to a resting state and in this process sometimes emit a small amount of light energy This energy is less than the excitation energy and so has a different color That is the emitted light fluorescence emission is red shifted from the excitation light and is much less intense Fluorescent optodes from optical electrodes essentially measure the intensity of light emitted from fluorescent dyes The emitted light is distinguished from the excitation light by means of optical filters Because the excitation light energy is kept constant the amount of emission light that results is affected only by the concentration of the analyte The e A concentration of the analyte is determined by calculating the difference in fluorescence measured at a known calibration point and fluorescence measured with the sample s unknown concentration of analyte The PO optode measurement principle is based upon luminescence first documented in the 1930 s and commercially utilized to measure blood PO in 1983 The relationship of luminescence to PO is quantified by the Stern Volmer equation which describes how the fluorescence emission intensity I is reduced as the PO P is increased Unlike conventional electrochemical Clark PO electrodes the oxygen optode does not consume oxygen molecules dur
26. blood gases electrolytes hematocrit and glucose Diametrics will continue to expand the testing menu of the IRMA System as well as the flexibility of the system and its adaptability in many clinical situations Agilent Technologies IRMA Blood Analysis System delivers laboratory quality blood test results where they re needed most at the point of care IRMA is intended for use in adult pediatric and neonatal intensive care surgery and post anesthesia and emergency applications Point of care blood testing is designed to reduce turnaround time of test results streamline processes increase staff efficiency improve outcomes and reduce overall operating costs Product Information Cassette Types Available Cassette Type Combo CC Blood Gasses H3 Measured pH PCO2 PO2 pH PCO2 PO2 Parameters Hct Hct Calculated HCO3 TCO2 HCO3 TCO2 Hb Paremeters BEecf BEbid SO2 BEecf BEbid SO2 Hb iCa n Strengths Alliance with Hewlett Packard Glucose strip testing directly incorporated into IRMA Lightweight 5 5 lbs AVOX Cooximeter Measures tHb 02 Sat MetHb and COHb Data Storage Capabilities 200 Patients and 300 QC Results Weaknesses e Injection Technique e Potential for blood splatter Operator must displace gel which can result in gel readings vs blood readings e More training inservicing time required M
27. developed to the proposed N I S T standard NCCLS Document C39 A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum approved standard OPTI R Analyzer Correlation to Predicate Methods OPTI R vs OMNI pH Sample Data Regression Identity 7 0 7 1 7 2 7 3 74 7 5 7 6 OMNI Correlation number of pairs n 178 slope m 1 03717 y intercept b 0 26539 y intercept normalized 0 0097 regression coefficient r 0 98167 correlation coefficient r 0 99079 std error of y estimate 0 0121 average difference 0 0083 SD of differences 0 0125 P T lt t two tail 0 37 OPTI R Analyzer Correlation to Predicate Methods OPTIR vs OMNI 2 120 m mmHg 100 24 E 80 60 4 E 0 Sample Data Regression 20 Identity 0 0 20 40 60 80 100 120 OMNI Correlation number of pairs n 178 slope m 1 05124 y intercept D 3 19544 y intercept normalized 1 1457 regression coefficient r 0 98330 correlation coefficient r 0 99161 std error of y estimate 1 7984 average difference 0 874 SD of differences 1 91 two tail 0 54 Analyzer Correlation to Predicate Methods OPTIR vs OMNI PO2 300 250 200 OPTI R 150 100 m Sample Data Regression 50 Identity 0 50 100
28. either during or after the measurement is completed it is not possible to define a Pat ID for that result after the result has been stored to the internal memory 6 6 2 3 Using Operator Identification Numbers Operator identification numbers ensure an unambiguous identification of results and patient samples The OPTI R Analyzer is designed for entering operator identification numbers referred to as Op IDs in the following Entry can be configured to be optional or required under the setup menu A numerical Op ID may be entered either directly on the instrument using the numeric keypad on board bar code reader or by means of an optional external bar code wand connected to the port on the rear of the instrument The length of the Op ID may be entered in a range of 1 and 10 Rhe OPTR An Op ID may entered either during or after the sample measurement depending on the instrument configuration under setup Secure Op ID s allow the facility to lock out unauthorized users from operating the analyzer With Secure OP ID s activated under Setup the administrator may store up to 150 unique operator identification numbers in memory each with an associated 4 digit PIN number At the time of operation the user is prompted to enter their unique 4 digit PIN however it is the associated operator identification number not the PIN which is shown on the printout This feature offers true security 6 6 2 4 Using Accession Numbers A
29. etc called interfacing Critical issues for the user Interfacing is a very complex topic Therefore the IT department asks for analyzer data management systems which interface with their system without adding excessive cost and or complexity i e special wiring special hardware software changes There are standard interface formats and protocols which make interfacing easier and more cost effective Ideal situation The standard network system together with their LIS HIS system can be used In the near future we will provide the solution for all these IT demands by offering you our DataCare POC Information Management amp Connectivity software The software provides bi directional data communications with Roche blood gas glucose and coag devices remote connectivity LIS HIS interfacing and regulatory compliance The intended users are Point of Care Coordinators amp Respiratory Manager s managing POC amp Critical Care Testing inside and outside of the central laboratory to maintain quality oversight and regulatory compliance Important OPTI R features to highlight ASTM and ASCII data protocol e Standard serial port RS232 e SerialIR port e Data integration using DataCare OMNILink e ASTM HL 7 interface of DataCare OMNILink to HIS LIS e Data integration of not only but also bench top Additional information The OPTI R can be directly interfaced to the facilities HIS LIS system However this requires th
30. higher oxygen levels into the patients lungs 4 5 1 Types of Oxygen Therapy e Nasal Cannula e Face Mask e Ventilator Provides Oxygen and Breathing Assistance Controls rate and strength at which the patient breaths Impacts carbon dioxide levels Increased breathing rates Lower carbon dioxide levels Decreased breathing rates Higher carbon dioxide levels General Terminology PS Pressure Support TV Tidal Volume PIP Peak Inspiratory Pressure Pplat Plateau Pressure PEEP Positive End Expiratory Pressure 4 6 Arterial Blood Gas Sample 4 6 1 Arterial Blood Sample Sites e Radial Arteries Wirist Area Brachial Arteries Upper Arm Area Axillary Arteries Armpit Area Femoral Arteries Scalp Artery Neonatal ICU Patients 4 6 2 Arterial Blood Sample e Exposure to room air alters PO values e PO and PCO values can change even while in a syringe If placed in ice the metabolic rate of the blood will decrease 4 7 Blood Gas Collection Devices 4 7 1 Syringes e Blood Gas Kits Heparinized Syringes Brachial Arteries Anticoagulant of choice especially when electrolytes are being analyzed Sodium Heparin Less commonly used 4 7 2 Capillary Tube Tubes or Samplers Heparinized Glass Sealant 4 7 2 1 Capillary Sampling e Capillaries are close to the surface of the skin Good indicator of delivery in babies Typical Heelstick
31. hospital market may be targeted by the OPTI R Critical Care Analyzer Operating Room Emergency Department Stat Laboratories e Main Laboratories backup for benchtop analyzers 4 Medical Background 4 1 Blood Circulation 4 1 1 Types of Blood Vessels 4 1 1 1 Arteries Arteries carry blood away from the heart muscle Blood contained in the arteries is high in oxygen content and is bright red in color The PO and PCO levels remain relatively unchanged until the blood reaches the capillaries Arterial samples provide a good indication of the patients overall blood and body conditions These type of samples also provide the clinician critical information regarding e Lung Function Ability to exchange Oxygen and Carbon dioxide e Cardiac heart Function Assess blood circulation and fluid balance 4 1 1 2 Veins Veins carry blood to the heart muscle Blood contained in the veins is low in oxygen high in carbon dioxide and dark red in color Samples drawn from veins provides a good indication of local tissue function However these types of samples are not often used by clinicians because the results vary widely from site to site 4 1 1 3 Capillaries Blood contained in the capillaries is low in oxygen high in carbon dioxide and dark red in color Samples drawn from the capillaries offers minimal clinical information except for pre mature babies neonates These type of draws are primarily performe
32. is a GP market In the GP scenario with the OPTI R Analyzer physicians generally do not have rapid access to lab results This can cause unnecessary delays as well as unnecessary hospitalization In some cases the OPTI R Analyzer can facilitate decision making 5 11 Sales Strategy In countries where blood gas analyzers are already implemented it is important that all potential OPTI R analyzer customers are contacted to be taught about the availability of the new Roche OPTI R Analyzer and to be offered more information On the benefits of Point of Care technology and the features and benefits of the OPTI R Analyzer which differentiate this technology from our competitors Use the 3 key success factors gt Roche s high familiarity rates at all target groups gt High attractiveness for potential customers gt High customer s loyalty The sales strategy will depend on the country that is involved but Rhe OPTR In many countries the main customer Operating Room is not yet visited by the Roche sales force The launch availability of the new Roche OPTI R Analyzer with reusable cassettes gives us the opportunity to contact this customers talk about Hospital Point of Care Testing our broad product portfolio and service concepts and the resulting benefits for the customers We must have a new focus on this customer group if we want to sell the Roche OPTI R Analyzer successfully In addition we also have to look after our customers in
33. or only from the display printout and export It also removes any calculated parameters which utilize this measured parameter Disabled parameters are not QC controlled Blanking This feature is configured under Setup It allows the user to remove any parameter from the printout and export during the measurement run time Edit Patient Data Blanked parameters are still displayed and are under QC control What is the purpose of the 4 digit PIN The 4 digit PIN offers true security if enabled under Setup the user will be prompted for his her PIN however the user ID number is what will be printed on the patient report this prevents anyone from utilizing a number on the printout to gain unauthorized access to the analyzer What Proficiency Testing Material is qualified for use on the OPTI R Critical Care Analyzer At the present time only the CAP survey material is qualified for use on the OPTI R Analyzer This survey material supplies values for all parameters measured on the OPTI R except tHb and SO2 and should be reported using the OPTI R code supplied with the material How do I report tHb and SO2 for proficiency testing According to CAP if no compatible material exists then the facility must run split samples 1 2 per month between a predicate device and the OPTI R to establish proficiency on the OPTI R The differences between these measurements are established and documented as acceptable by the la
34. six 6 months of age e Methemoglobin metHb CO Oximeter Measurement Dysfunctional Hb which cannot carry O This can be acquired or attained from a congenital disorder CO Oximeter Most blood gas analyzers yield SO readings that reflect a combination of saturated and unsaturated hemoglobin Fractional and functional Hb CO Oximeters differentiate between saturated and unsaturated hemoglobin Fractional and functional Hb The OPTI R is NOT a CO Oximeter e Plasma 55 e White Blood Cells Less than 196 4 10 Electrolytes 4 10 1 Electrolytes What do they do The body requires Electrolytes for Metabolic activities Electrolytes maintain water distribution in various body fluid compartments and are required for proper function of the heart and other muscles These electrolytes regulate pH 4 10 2 Sodium e Maintains distribution of water and osmotic pressure in the extra cellular compartment High Na identified by vomiting diarrhea Infusion of high salt IV solutions Low Na identified by vomiting diarrhea diuretics 4 10 3 Potassium K e Potassium is a major intra cellular cation Disturbances in potassium levels have severe consequences on the human body leading to muscle weakness paralysis fast heart rate and cardiac arrest High K identified by vomiting diarrhea and dehydration Severe burns will cause potassium levels to rise Infusion of high salt IV solutions
35. the decentralized wards ER ICU and CCU Nurses should also be taken into account when promoting the OPTI R Analyzer as they in most cases will be the ones doing the measurements Demonstrating to them the easy handling should make them confident with our product 5 12 The Sales Process Common Customer Questions Our Answers How does the OPTI R measure tHb and SO2 The OPTI R utilizes a technology known as optical reflectance using a single laser diode located in the cover of the sample measurement chamber Three different wavelengths are utilized in these measurements including two for tHb and one for SO2 The wavelengths used were selected to minimize interference from one another Can the OPTI technology identify patients who smoke or are suffering from smoke inhalation No the OPTI R s tHb value includes measurement of Oxy hemoglobin and Deoxy hemoglobin levels When assessing for smoke inhalation physicians are interested in Carboxyhemoglobin measurements which the OPTI R does not measure What type of sample can be measured on the OPTIR Analyzer Whole Blood Serum Plasma Non colored containing dye aqueous quality control materials How does the OPTI R handle hemolyzed blood The OPTI sensors are not affected This also applies for the and SO analysis 20 Tsas Can the OPTI R handle iced samples Yes all samples are heated to 37 C by the OPTI R s solid state heater The entire measur
36. they may be modified to achieve varying ranges of the measured parameters An example is shown below High tHb Stand syringe on end and let the plasma rise to the needle end Eject this plasma and measure to achieve high values of tHb LowtHb Stand syringe on end and let the red cells fall to the needle end Eject these cells and use plasma to taint other samples Thus providing lower tHb values The remnant samples may be mixed with salt exposed to room air or other varying techniques to gain a wider range of measured values This will lead to an overall better correlation 8 2 3 Special Thoughts and Considerations e Sample should be collected in a larger than 1cc syringe e Lithium heparin is the recommended when conducting correlation s of this type e tis recommended to compress the time between sample measurements as much as possible This is extremely important when using the results from the reported measurement e Never run the OPTI Analyzer first when conducting a correlation since the OPTI aspirates the sample and will then contaminate the remaining sample material This is true with any instrument that automatically aspirates the sample for analysis Ifthe predicate device automatically aspirates the sample the OPTI measurement will then vary from the predicate device 9 SERVICE CONCEPT Roche OPTI ANALYZER 9 1 Service Aspects Please find below a short description of the OPTI R Analyzer ser
37. 00 calibrations and is easy to insert into the analyzer e User setup option for six 6 languages English German French Spanish Italian Japanese Easy user interface with several setup options and a 14 button keypad Very easy handling minimal training is required No sample preparation is required Self contained OPTI R SnapPak provides reagents for multiple tests and serves as a wash and waste reservoir e Fast reliable results and printout in approximately 1 minute from sample aspiration e Sample and control modes of operation Press 1 for patient sample 2 for control e Interface options include RS 232 and IR ports and can be configured for ASTM or Mobil ASTM output all output fixed at 9600 baud Memory buffer storage can accommodate more than 150 patient results and one months quality control and statistical data On board printer for clear error free results reporting On board bar code reader for entry of all lot specific information as well as accession numbers OP IDs and Pat IDs Roche OPTR 6 5 2 OPTI R Analyzer overview 1 OPTI R Analyzer 2 Battery 3 Printer Paper 4 Power Supply 5 Power Cord US only 6 Printer Peristaltic Pump Compartment 10 6 a Printer 6 b Peristaltic Pump Cartridge 7 Sample Measurement Chamber SMC 7 a tHb SO Cover 9 7 b Optics Lens 7 c Outlet Port 7 d Cassette Valve Drive 7 e Inlet Port 8 Bar Code Reader 9 Key Pad
38. 10 Liquid Crystal Display LCD ee A 11 IR Port 12 OPTR R SnapPak Compartment 13 Serial Port 11 14 Battery Charge Indicator LED 15 Optional Barcode Wand Port 16 Fan 12 13 15 14 SSCS A sss 6 5 3 The READY STATUS Display READY 19Remain 22NextCal 1 2 QC 3 Menu gt The READY display informs the user of important status information such as e 19Remain Number of samples remaining on the cassette i e 19 patient samples remain e 22NextCal Time remaining to the next automatic calibration i e 22 minutes Resets to 30 minutes after each patient or QC measurement 1 Sample Press 1 to run a Patient Sample 2 QC Press 2 to run a Quality Control Sample 3 Menu Press 3 to access the Main Menu You may also view the status of the OPTI R SnapPak on board calibration gas bottle or type of cassette currently installed in the instrument To view the status of these items from the READY display press the right arrow key gt STATUS 895 Gas 52 Type ECaXX Exp 4day 18hr 6 5 4 Technical Principal 6 5 4 1 Sensor Technology Luminescence is the emission of light energy resulting from excited NM molecules returning to a resting SIS C state When luminescence is 4 initiated by light it is commonly referred to as fluorescence When a fluorescent chemical is exposed to 7 light energy of an
39. 2 0160 LON HON3J HON3H4J S YOLVEAdO IWANVW S 02 d 080869201 080869701 0 X TLNI TON IWNOLLVNSH3LNI SdO VEOLGd 1000892016 000892010 NVIAH3O NVIAH3O9 S HOLVH3dO IVANVW 660244 LOOLZ9ZOLE 1001 9 0160 eve 0002 4 99304 Jejdepy sed 06 269 49 100 929816 L00792vvLeO Jeydepy 921 sieydepy Duu S 009 4 OgL6SSEELE 108 68866160 enesse y 3dAL SZ VO 3 3113SSVO 09 O8LZESEELE 08 26666160 X X X X X X X 1109 SVO 5 100 9 OSLEZEZTLLE 08 6 601160 X X X X X X X uonnjios MOVddVNS 1140 2602d8 08 9662 16 0819662210 T3A31 IHL 5193HO LLdO 108 800 08LZZOELLE 0812061160 Jeydepy 06 abun 268 48 100 929916 L00Z92vvL O Jeidepy 921 sieydepy 5 OSL6SSEELE 08 69922 20 Jed SZ VO 3 3113SSVO L094d8 08 2686616 08 26866160 10 9 qe IeAe YOIYM SUI9 J 4 ysiueds
40. 4 Threats e Price erosion caused by competitive pressures i STAT next generation analyzer e New Gem Premier PLUS Analyzer with color touch display user interface 5 7 OPTI R Unique Selling Points USPs Room Temperature Storage of Cassettes at ALL times No refrigeration of cassettes required No time consuming equilibration Automatic Aspiration of Sample Makes sampling easy and safe Eliminates underfilling or overfilling the sensor cassette e Barcode Calibration of Cassettes No calibration codes for the operator to enter which eliminates potential for operator input error due to incorrect patient ID calibration code and lot number information On Board Storage Capacity gt 150 patient records plus three 3 levels of quality control data for one 1 month stored on the analyzer Flexible Connectivity Options Infrared IR RS 232 both via ASCH ASTM or Mobil ASTM communication e Measured and Saturation 50 Measured tHb is much more accurate than measured HCT through conductivity I STAT Irma GEM and ABL 70 all measure HCT through conductivity that can render a falsely decreased result when used in conjunction with plasma expanders cardioplegia in O R settings Can lead to unnecessary transfusions e Automatic Gas Calibration Increases accuracy and stability OPTI SnapPak Provides reagents for multiple tests and serves as a safe wash and waste reservoir Ease of Use e A
41. Analysis 4 8 Blood Gas temperature Correction Direct relationship between Temperature and Pressure impacts and PCO values e Temperature impact on PO is minimal Example Patient Temperature changes from 37 39 the impact on is from 100 110 mmHg e Temperature impact on is greater than PO Example For each degree Celsius elevation the PCO is impacted by 5 e PCO impacts pH e Blood gas values are typically measured at 37 C Temperature Correction is desired by clinicians 4 9 ABCs of Blood 4 9 1 Blood Components Red Blood Cells RBCs or Erythrocytes 45 RBCs contain Hemoglobin Hb Carries blood and Carbon Dioxide throughout the body Each Hb molecule can carry up to four 4 oxygen molecules Saturated Hemoglobin contains oxygen De Saturated Un Oxygenated or De Oxygenated Hemoglobin contains no oxygen 96 Hb carrying O2 in Arterial Blood is known as Oxygen Saturation of Arterial Blood SaO or Saturation Saturation reflects only a portion of available Hb Abnormal Hb Components Carboxyhemoglobin CO Oximeter Measurement Hb combined with Carbon Monoxide expressed as a percentage 96 of total hemoglobin Provides clinical indication Smokers as high as 1096 Carbon Monoxide Poisining e Fetal Hemoglobin HbF CO Oximeter Measurement Foundin the fetus with greater affinity for O than adult Hb Approaches adult ranges around
42. Approved Guideline April 1993 for a detailed discussion of guidelines for the collection of acceptable specimens instrument calibration and quality control in pH and blood gas analysis including details of many potential sources of error which may cause inaccurate results Whole blood samples should be collected in a heparinized syringe Roche Microsampler or capillary and analyzed as soon as possible after collection Immediately after collection check the syringe or other device for air bubbles and carefully expel any trapped bubbles following the manufacturer s recommended procedure Extreme caution should be used to avoid needle stick injury If collected in a syringe or vacuum tube mix the specimen thoroughly with anticoagulant by gentle inversion or by rolling the syringe between both hands Properly identify the specimen following usual procedures for such documentation Place the syringe containing the specimen in an ice slurry Blood gases pH and glucose content will change if the specimen remains at room temperature in a syringe for more than 5 minutes due to cellular metabolism changes due to oxygen consumption may be influenced by several factors including white blood cell count reticulocyte count storage temperature and initial PO value At storage temperatures of 1 to 5 C the results obtained from the specimen are valid up to 2 hours Samples expected to have high white blood cell count reticulocyte count or hi
43. C to the OPTI R Analyzer Once the measurement is complete the result is automatically transmitted including all available information such as date time Pat ID Op ID additional patient demographics and measurement results For this purpose the Host PC connection must be configured under the setup menu The Host PC is connected via wireless transmission IR Port or the standard serial port by means of an RS 232C cable with three 3 data lines For further details please refer to the OPTI R Operator s Manual 6 6 6 Quality aspects Instrument Self Check Standard settings are done by Roche during the manufacturing process Internal checks are automatically accomplished each time a new cassette SnapPak or gas bottle is installed Further verification of the system is done during the measurement wash and calibration phase of the overall sampling cycle For routine check s of the system performance control material can be ordered by the customer OPTI check Quality Control Material in order to check whether the system Analyzer and Cassette gives results that are within a certain target range 6 6 6 1 General Information on Error Detection and Correction The OPTI R has a user friendly design Following all instructions given in the Operator s Manual should therefore prevent that errors occur Should however an error occur the customer should follow the instructions given in the OPTI R Operator Manual If in
44. LE LOOL9ZSOLEO ZH 9 OWA OLL YSDYVHO AH3 LLVG 960148 LOOOZEPOLE LOOOZEVOLEO 69 29 OWA 022 H39OHVHO AH3 LLVG ScO dd LOOEDEPOLE LOOEOEVOLEO dO ADVLIOA MOT HMd v00ZI3 LOOZEZ980 LOOZEZ980 0 0LL6 38OHd 131 15 0208 L00912980 L00912980 0 39GlH LHVO 310V Ld3938 920234 LOOS69Z80E LOOS69Z80E0 WZ 1 867 H3MOd 318VO Z6L0XA4 LOO8EE690E LOO8EE690E0 SV1d LVN IW 001 1109 9600 100609890 LO0609890 0 1 ZL 1000511 100889 906 L00889290 0 GALAIdNOO AYALLVE ASSY 400 4 LOOZLOL90 LOOZLOZ90 0 p p g JOPIO ed aied Roche OPTI R March 2000 6 4 Roche OPTI R Analyzer Characteristics 6 5 Roche OPTI R Analyzer Roche OPTI R Analyzer 6 5 1 Key Features e Room temperature storage of cassettes for up to six months from date of manufacture e 5 day on board stability of the cassette e For greater security QC lockouts ensure that quality control testing is always performed in accordance with your regulatory requirements e Passwords and secure ID s provide access to various system functions and limit access of the analyzer only to authorized users e Can be battery or AC operated The rechargeable battery allows independent operation for up to 8 hours e The calibration gas bottle provides a true gas calibration with each measurement for optimum stability and accuracy Each gas bottle supplies up to 2
45. Launch Book Roche OPTI R Critical Care Analyzer March 2001 For internal use only OSS TO Table of Contents 1 INTRODUCTION 1 2 8 Hemoglobin Oxygen Saturation SO 4 Anticoagulants and Sample Collection Devices Stability of Samples Blood Circulation Marketing of the Roche OPTI R Critical Care Analyzer MEDICAL BACKGROUND Treatment of Abnormal Blood Gas Values Arterial Blood Gas Sample Arterial Blood Sample Sites 5 5 1 5 2 5 3 6 1 LI 2 2 1 i 3 5 6 6 1 6 2 71 72 8 9 9 1 10 3 2 Point of Care Testing US Hospital Surve OPTI R Unique Selling Points USPs 8 10 Effective Selling Messages 10 2 Intensive Care Unit Coronary Care Unit 10 3 Cardiac Catheterization Lab 13 1 1 1 TECHNICAL FEATURES OPTI Critical Analvzer The Analyzer in brief 22 Brand Names 5 6 6 1 6 2 Weaknesses 6 7 9 Advertising Promotion Printed Materials 3 Order Check List 4 Roche OPTI R Analyzer Characteristics Roche R Analyzer OPTI R Analvzer overview 2 3 6 5 8 Handling Steps 60 5 5 5 5 5 6 Software Overview Quick Reference Guide 6 1 Quick Reference Guide 6 2 Internal Memory Functions 6 3 OPTI Analyzer Technical Data 6 4 Peripheral equipment optional 6 5 Data Manager PC Connection 6 6 Quality aspects Instrument Self Check 6 7 Consu
46. N BSU seg ddO NO 34O NO 149164 MONETA eed 054 peunbe jeuondo 34O NO 3dO NO OJU Svid e9 eed zuana 19 u3 oeg Sec sseg MIN Aejdsiq nue 941 88914 ajdwes e UNY O Zu SseJd jueneg e uns 589141 lt eidues 96 94Se WEG Ad SnjelS 4 __ fe dsig snjejs ay O lt 569144 ACVAY AGINS MOInO 1979 YIINO MIIAIBAG 9 9 0 jeuondo ut JO 9 10 un uj Aiepeg 1uened uo pue pus 10 eles jpa eu 1 88914 H31N3 10 1deooy 0 J9 u3 SS Jd SSVd 5 2S3 889 4 AQYJY 104 lt 993 gt SseJd AQYJY 104 Asayyeg d
47. OR ICU and other critical care environments e Rapid on site testing Always Ready for immediate testing no warm up time required One reusable multi sensor cassette providing multiple patient results up to 25 eliminates switching in the middle of critical procedures and reduces costs and operator handling e Onereusable multi sensor cassette enables to measure the combination of blood gas electrolyte parameters and tHb S0 Parameters pH P02 PC02 50 K Offers convenience and safety due to the SnapPak which contains the wash calibration solution required for all parameters and includes a sealed waste container Portability and simple handling e Accuracy that compares to our benchtop systems T s 3 Executive Summary 3 1 Intended Use The Roche OPTI R Critical Care Analyzer is a powerful tool designed to help you quickly efficiently conduct basic testing of pH PCO and SO in samples of whole blood and pH and in serum and plasma in either a traditional blood gas clinical laboratory setting or point of care locations by personnel minimally qualified to perform and report these results The Roche OPTI R Critical Care Analyzer the cornerstone of the system is a small portable instrument that minimises dependence on the central laboratory facility when rapid results are neede
48. R Jo 10014114 LYO ippeq UddIDSYINO Uoo15sQ noj Uoo15SuQ noj dol c 10 02 c Aeydstq jo od T VIN VIN 96 0 96 UO VIN VIN 96 10 205 VIN VIN 1 8 10 VIN VIN 1 8 qm VIN T Tourur VIN VIN VIN VIN VIN VIN T Tourur VIN VIN VIN VIN VIN VIN T Tourur VIN VIN VIN VIN VIN np VIN T Tourur 170 VIN VIN VIN VIN np VIN 170 T Touru 170 170 VIN VIN VIN 40 T ouru 1070 1070 0 0 1070 T jourut 1070 1070 T ourur 1070 TED 170 170 0 T jourut 1070 T ourur 0 1070 T jourut 1070 J 1 T Tourur T Touru 170 170 T Tourur Tjouu 170 170 HEN Spur sHU 0 Spur 0 Sppurur 0 8 sHU 0 1070 10070 10070 10070 1070 1070 10070 Hd eqdsiq Jo uorn oso VIN VIN 001 0 001 09 VIN VIN 001 09 TOS 1 8 cc 2 1 8 60 6 1 8 60 6 VIN VIN VIN VIN VIN VIN oc I VIN VIN VIN VIN VIN rN V N TWU 5679 VIN VIN VIN VIN VIN PI V N T Jouurgsy 0c TOW 866 01 VIN VIN VIN VIN PI V N TWW 02 11 ouu pac 9 091 06 VIN VIN VIN o s 20 69 6 600 06 20 T ouuos rpr
49. Roche Response POSITION Roche OPTI takes too long to calibrate Roche RESPONSE Roche has a comprehensive calibration process to ensure reliability Although the calibration time may be seconds longer we make up for it in shelf life bar code calibration data ease of sampling etc POSITION Roche is too heavy to be POC It can only be utilized as Near Patient Roche RESPONSE The majority of hospitals utilizing IRMA Analyzers are using them as Near Patient devices It is not financially feasible for a hospital to purchase an IRMA Analyzer for every bedside The OPTI R is still portable Roche OPTR POSITION The OPTI R requires a lot of maintenance Roche RESPONSE No instrument is totally maintenance free The maintenance requirements of the OPTI R are minimal 7 2 6 Radiometer http www Radiometer com Corporate information collected via the internet and or other Radiometer Corporation sources and is subject to change More than 40 years experience in the blood gas business makes RADIOMETER the pioneer in this field The Denmark based company develops manufactures markets and services state of the art critical care and monitoring equipment RADIOMETER offers state of the art blood gas analyzers including analyzers for electrolytes oximetry and metabolites supported by superior training and service RADIOMETER in cooperation with the clinical chemistry pioneer Prof Poul Astrup M D introduced the world s f
50. Sample aspiration training analytical reliability e Data transmission IR Convenient cassette storage at Room Temperature for up to 6 months from date of manufacture QC lock outs e Minimum maintenance requirements Additional information Labs wants to maintain control for different reasons Point out the OPTI R features which help to maintain control such as Password protection PW1 PW2 PW1 PW2 two levels limit access to various system functions authorized user administrator levels or both QC Lockouts provide security to help hospitals maintain their QC policies e Secure Operator ID s limits analyzer access to properly trained authorized users Decision Drivers Regulatory concerns Remaining compliant Connectivity Maintaining control Performance Correlation to traditional laboratory instruments e Menu Additional OPTI R Features to Highlight Connectivity Options Makes downloading patient and QC samples simple so they remain in control no matter who performs the test e QC Lockout Ensures that testing is not done on an analyzer that has not passed QC even when they cannot physically be there e Data Storage and Flexible Connectivity Automatic Aspiration of Sample Demonstrates overall ease of use and low training requirements especially important to POC coordinators who are responsible for training activities 5 10 5 Emergency Room
51. Six 6 field test sites were utilized in this study three 3 U S and three 3 international reporting a combined number of patient samples of 1 346 8 1 3 Overview of Study Protocol According to the study design for the performance study four 4 lots of Roche OPTI R sensor cassettes and three 3 lots of Roche OPTI R SnapPak s reagent were utilized at the field test sites Number of test units utilized for this study was nine 9 8 1 4 Sample Range Sample measured over this study fell within the following ranges per parameter Parameter Low High Units pH 6 890 7 600 pH 21 0 136 2 mmHg PO 27 1 527 0 mmHg Na 99 1 171 0 mM K 1 8 9 4 mM 0 5 2 5 mM tHb 5 8 18 1 G dL SO 61 4 100 0 96 8 1 5 Conclusion The Roche OPTI R performance as evaluated over all field trial sites performed within the specified acceptable limits for the analyzer This data also shows similarities to the currently available Roche OPTI critical Care Analyzer when operating with equivalent E Ca Type single use cassettes This data was also reviewed as part of the Roche OPTI R peer review meeting held on September 19 and 20 2000 Roche OPTIR The following data attained at one of the field trial sites is presented as a comparison against the current Roche OMNI Analyzer NOTE Data shown for iCa differs from the predicate device due to N I S T Standardization The Roche OPTI R has been
52. WUT PZ 16 6 uugoc urg er umnugpc urc zG 072 06 9 0 unugpcz utc 6 y d p utr TI 10002 UI 2 27 uruoc 0 Ur O ZI 0 ur OTT wwzog ppm uru z ut o s uurz ureg umugop urg gr ummpzp ur zgy WOT EP 6 19 USOT unupc ur g y Suorsuaur q ZH09 0S 2 09 05 9 06 9 06 209 08 OVAOSC 7 09 0 OVAOSC ZH09 0S OVAOEC 06 perddns poumnbo jy pormbei jy 06 perddns STT 4 10dsuen smoye smoje Jo depe 4 p rddns 123depe 2909 05 10 4 10 Tamod UOU 1191164 AVOIN 09 A ddng 09 4 ddng AVOIN 10 19124 6X7 001 SUHMS 8 ddng 96AO CS ULU 96 AS ULU jo jo uorne no eo 1 1 10 10 30 30 skep RIA uonejs pue pue 103 81891 DO pue pnu DO 001 pue
53. a new cassette through the bar code reader 6 5 7 Specimen Collection and Handling 6 5 7 1 Safety Universal precautions must be observed when collecting blood specimens It is recommended that all blood specimens be handled as if capable of transmitting human immunodeficiency virus HIV hepatitis B virus HBV or other bloodborne pathogens Proper blood collection techniques must be followed in order to minimize risk to the laboratory staff and gloves should be worn Please refer to NCCLS document M29 T2 Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue Second Edition Tentative Guideline for further information on safe handling of these specimens 6 5 7 2 Sample Requirements Refer to NCCLS document H11 A2 Percutaneous Collection of Arterial Blood for Laboratory Analysis Second Edition Approved Standard May 1992 for detailed information on sample collection storage and handling 20 sss Blood sampling for analysis must be performed under proper medical supervision with details of collection including sampling devices site selection sample handling documentation and specific procedures used approved by the personnel responsible 6 5 7 3 Anticoagulants and Sample Collection Devices Lithium heparin is the only acceptable anticoagulant for blood gas and electrolyte analysis Lithium heparin sodium heparin or balanced heparin salts are the only acceptable anti
54. alosis as represented by pH and PCO values with high PO High values of K and Low values of Ca and with normal SO Vials identified by a blue label Storage Refer to package labeling NOTE When entering assay ranges on the OPTI R Analyzer be sure to use the correct assay sheet identified by FOR USE WITH THE OPTI R ANALYZER ONLY OPTR 7 Competition Analysis 7 1 Overview Competition to the Roche OPTI R Analyzer will consist of direct competition to the Hospital Point of Care market However Roche offers a truly portable multi use analyzer for use in Hospital Point of Care Applications oy moyym mopm uonoefu uonoefug uoneidsy uoneidsy uonoefug uonoefuj uoneidsy Sur dureg amp per odg amp amp 2 44 4 oSuni g 4 oSuni g oSuni g oSuri g oSuni g o dureg eui JA spuooos spuooos spuooos juaulaInseo A peyredg3oN OZI 06 xoiddy 071 xoiddy 061 46 130N 4 061 spuooos spuooos spuooos spuooos spuooos spuooos spuooos 06 xoiddy 021 06 xo1ddy 09 xoiddy 06 xoiddy FOL
55. ange i amp miuh F GEM Premier GEM PCL Strengths e Market Leader in the OR e Menu ITC POC Coag with ACT Activated Clotting Time e Low cost of Multiple Cassette Pack if all tests are used Weaknesses Capital Outlay High analyzer cost Large Size Difficult to Accommodate Varied Testing Volumes Test Packs available in 150 or 300 tests Many Perfusionists will throw out remaining pack at end of day which results in a lot of wastage One Hour Warm Up Time Changing a Cartridge is Time Consuming e ttakesa minimum of 1 hour minutes to perform a cartridge change PLUS Not stated for the 3000 e Limited Connectivity PLUS e Serial Cable Only PLUS Roche Advantages to Highlight e Small Size and Battery Option of the OPTI Analyzer More Flexibility and Portability options e Code Scanning Capability for entry of Accession number Operator ID Patient ID QC and Cassette Calibration Lot Information e Significant reduction in the potential for operator entry e Emphasize Minimal Maintenance Requirements of the OPTI R Analyzer GEM Position Roche Response POSITION Benchtop technology is more accurate and reliable than optical technology Roche RESPONSE Six point calibration done at the factory along with a calibration prior to each individual measurement or at thirty minute intervals whichever comes first ensures reliability Also correlation data to bench to
56. anual Entry of Cartridge Calibration Operator must enter cal code lot information and patient id which can result in operator errors These must be corrected by POCT coordinator at the IDMS computer level e Cartridge needs to equilibrate to hospital temperature for 72 hours prior to use e Difficult to use in the OR setting e Cartridges must be used in the operating range of 59 86 F If cartridges are stored outside the OR suite then it takes 72 hours to equilibrate to the OR temperature e Cartridge Shelf Life 5 Months Open Pouch Stability 10 Minutes e Not Compatible with Regular Capillary tubes Must purchase proprietary capillary device at approx 1 00 each e Interfaces to LIS HIS are Minimal Rhe OPTR e Currently interface to Cerner and 541651 Having major difficulties interfacing to Meditech Roche Advantages to Highlight Automatic Aspiration of Sample e Eliminates any special techniques required for sample introduction e Minimizes training requirements e Nochance of blood splatter e Uses standard capillary tubes no additional expense Bar Code Capability e Calibration Code entered via bar code on cassette Bar Code Reader available for operator and patient data entry Ability to Edit Delete Review Records at Instrument Level e Irma must be done at Data Management Level Extensive Shelf Life of Cassettes e 6Months Open Pouch Stability of One hour e 10 minutes on Diametrics Irma IRMA Position
57. ar easy to read thermal printout from on board printer Economy Convenient cassette storage at room temperature 6 months from date of manufacture at 4 30 C 39 86 F Costsaving opportunities due to improved turn around time and faster clinical decisions results available in approximately 1 minute after sample aspiration Accurate and precise analysis obtained by non technical personnel Reduced training requirements due to high degree of automation e Minimum maintenance requirements Convenience Flexibility Easy to use for syringe capillary or Roche Microsampler e Small size offers the opportunity of location near to the patient no special accessories are required Convenient cassette storage at room temperature 6 months from date of manufacture at 4 30 C 39 86 F Analyzer status reports on clear easy to read printout Calibration data scanned in utilizing the built in barcode reader Easy to clean maintenance free optical system No special collection devices required standard procedure and material accepted Reports a full menu of calculated parameters Correction for patient temperature e Input values for patient and operator IDs as well as accession numbers can be printed on the patient report e Input for various ventilator settings Input fields for Sample Type Ventilator Mode and O2 Modes e Automatic short sample and bubble detection 0 e Automatic detection and early warnin
58. aspirate Quality Control and Proficiency testing material directly from the ampoule This procedure helps to minimize sensitivity to pre analytic and other errors associated with the use of aqueous controls see Limitations Section All specific performance specifications reported in this Summary are determined from the above minimal recommendations for quality control verification Every hospital is required to develop its own policies and procedures for quality control checks Minimum guidelines are defined by a variety of regulatory agencies For agencies requiring a liquid QC material OPTI check is available 20 sss OPTI check is a specially formulated aqueous liquid control material that controls all analytes measureable by the OPTI R It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similarly to erythrocytes allowing true measurement of tHb and SO The three control levels contain three different concentrations of microbeads to simulate low medium and high hematocrit blood samples OPTI check provides a method of performing daily QC checks for laboratories selecting to measure liquid QC material 6 5 5 4 Calibration Verification Calibration verification allows for the validation of the blood gas analyzer s ability to recover known values at various points within the reportable range of all parameters and may be required by various regulatory age
59. atory normal ranges for arterial carbon dioxide tension are well documented and widely accepted Parameter Mean 2SD PCO mmHg 40 35 45 3 2 3 The value of arterial blood is used to assess how well the body is able to absorb oxygen in the lungs Values below the normal arterial PO arterial hypoxemia are usually caused by pulmonary circulatory or respiratory abnormalities e g bronchial obstruction vascular problems decrease in cardiac output increased oxygen demand anatomical heart defect low inspired O content Generally levels above 100 mmHg do not contribute significantly to the oxygen content since with normal 1 Shapiro BA Harrison RA Cane RD Kozlowski Templin R Clinical Application of Blood Gases 4th ed Chicago Year Book Medical Publishers Inc 1991 p 79 83 haemoglobin concentrations 80 100 mmHg PO provides a 97 saturation level and a level greater than 10096 cannot be achieved Reference Interval Arterial oxygen tension PO is dependent upon the inspired oxygen tension as well as various physiologic variables and the administration of oxygen is common in the treatment of patients in need of blood gas analysis Hypoxemia is defined as an arterial below an acceptable range while breathing room air with about 2196 oxygen at sea level Increasing altitudes above sea level will produce lower inspired oxygen tensions and therefore lower arterial PO values
60. boratory director If the measurements exceed this difference the laboratory director must then document the corrective action taken The key to success with this issue is DOCUMENT DOCUMENT DOCUMENT Can I interface the OPTI Analyzer to a computer based data management system Yes The OPTI R has two 2 serial interfaces including a standard 9 pin RS 232 port and an infrared port which will allow interfacing to a computer using either ASCII or ASTM data transmission Can I interface the OPTI directly to a hospital system Yes however this requires the facilities IT person to generate a PARSE program to act as an interface translator0 between the OPTI and the facilities system 5 13 Pricing As the Roche OPTI R system should be positioned between OPTI CCA lt 3 tests day and OMNI gt 10 tests day therefore our recommendation is to offer the OPTI R cassette box 4cassettes per box for an AUP of 185 USD to 235 USD 5 14 Advertising Promotion Printed Materials 5 14 1 Promotion Available for launch Product Brochure OPTI CCA OPTI Multiple Solutions for Multiple Situations AVL Part Number CH3724 Roche Part Number 3141896 Product Flier Technical Specifications OPTI R The Time saving Solution for Multiple Situations AVL Part Number CH3723 5 14 2 Intranet The related Intranet pages will be updated to include detailed information e g abstracts on a
61. capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture The puncture should be made deeply enough to ensure a free and rapid flow of blood Do not use clay capped capillary tubes as the rough broken edge left when the capillary is cut may cause damage to the OPTI R cassette fill port Use only capillary tubes with fire polished ends to prevent damage to the cassette If a mixing flea is used as required in some capillary tubes take care to remove the flea prior to sample introduction to avoid damage to the cassette Specimens collected in capillary tubes are stable at room temperature for up to 30 minutes after collection because of the rapid cooling of the sample accomplished during filling 3 5 2 3 Roche Microsampler Blood may be collected for analysis on the OPTI R with the Roche Microsampler to provide two filled capillary tubes After collection the Microsampler should be capped and transported in a horizontal position to the instrument for analysis within 30 minutes as with all specimens collected in capillary tubes 3 5 3 Stability of Samples Collect blood in a heparinized syringe a capillary tube or an Roche Microsampler Whole blood samples should be analyzed as soon as possible ideally within five 5 minutes after collecting the sample For a brief storage of up to one 1 hour the sample should be iced NOTE Whole blood samples require the proper amount of a
62. ccession numbers ensure an unambiguous identification of results and patient samples The OPTI R Analyzer is designed for entering accession numbers referred to as in the following Entry can be configured to be optional or required under the setup menu A numerical accession number may be entered either directly on the instrument using the numeric keypad the on board bar code reader or by means of an optional external bar code wand connected to the port on the rear of the instrument The length of the accession number may be entered in a range of 1 and 11 Rhe OPTR 6 6 3 OPTI Analyzer Technical Data Measured Parameters pH PCO ctHb SO Barometric Pressure Calculated Parameters Actual bicarbonate HCO Base excess BE Base excess Base excess actual BEact Buffer bases BB Total CO2 tCO Standard bicarbonate st HCO Standard pH st pH Oxygen saturation SO Oxygen content Hematocrit Hct c Hydrogen ion concentration Alveolar arterial oxygen partial pressure difference AaDO P50 Standardized ionized Calcium nCa Operating Parameters Minimum Sample Size Sample Type Sample Application Sample Input Analysis Time time to result Ambiant Temperature Relative Humidity Measurement Principle Range Resolution 6 6 to 7 8 pH units 0 001 pH units 10 to 200 mmHg 0 1 mmHg 10 to 700 mmHg 0 1 mmHg 100 to 180 mmol L
63. coagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and should not be used Lithium heparin should not be used for samples taken also for analysis of lithium 6 5 7 3 1 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the amount of blood required to minimize the effects of dilution of the blood by the anticoagulant solution Although plastic syringes are commonly used for collection of blood specimens for blood gas analysis there have been reports in literature regarding the use of plastic syringes when values higher than normal are expected Particular attention should be paid to cooling blood samples in ice water because of the CO and oxygen solubility in some plastics If blood specimens are expected to have very high PO values care should be taken to analyze the specimen as quickly as possible following collection to avoid the need for cooling Attention should be paid to thorough mixing of whole blood samples prior to analysis since sedimentation of blood cells affects the measurement of total hemoglobin 6 5 7 3 2 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume filled of 125 uL The Roche Roche Reference Number 03113477180 Capillary Tube is ideally suited with a minimum volume filled of 200 uL The Roc
64. d The total weight is less than 5 5 kg eleven pounds which makes it easy to transport wherever it is needed It can be operated either by its on board rechargeable battery for up to eight hours or directly from A C power The Roche OPTI R Analyzer is a nearly maintenance free device using solid state multi use optical fluorescence sensor cassettes and an on board OPTI R SnapPak The sensor cassettes can be stored at room temperature Each sensor cassette contains two 2 barcode labels which contain information such as expiration date lot number and calibration information The OPTI R Analyzer is ideally suited for any POCT areas including the following Operating Room Emergency Department Stat Labs Main Laboratory backup for benchtop analyzers 3 2 Importance of 3 2 1 pH The pH value of the blood serum or plasma may be the single most valuable factor in the evaluation of the acid base status of a patient The pH value is an indicator of the balance between the buffer blood renal kidney and respiratory lung systems and one of the most tightly controlled parameters in the body The causes of abnormal blood pH values are generally classified as a primary bicarbonate deficit metabolic acidosis b primary bicarbonate excess metabolic alkalosis c primary hypoventilation respiratory acidosis d primary hyperventilation respiratory alkalosis An increase in blood serum or plasma pH alkalemia may be due
65. d correlation 2nd Ed St Louis C V Mosby Co 1989 p 590 591 T ss abuse salt losing nephropathy osmotic diuresis metabolic acidosis adrenocortical insufficiency congenital adrenal hyperplasia dilution type due to edema cardiac failure hepatic failure and hypothyroidism Elevated sodium values hypernatremia are associated with conditions with water loss in excess of salt loss through profuse sweating prolonged hyperpnea severe vomiting or diarrhoea diabetes insipidus or diabetic acidosis increased renal sodium conservation in hyperaldosteronism Cushing s syndrome inadequate water intake because of coma or hypothalamic diseases dehydration or excessive saline therapy The sodium value obtained may be used in the diagnosis or monitoring of all disturbances of the water balance infusion therapies vomiting diarrhoea burns heart and kidney insufficiencies central or renal diabetes insipidus endocrine disturbances and primary or secondary cortex insufficiency of the adrenal gland or other diseases involving electrolyte imbalance Reference Interval Sodiunf sample type range mmol L whole blood serum and plasma premature new born 48 hr 128 148 full term new born 133 146 infant 139 146 child 138 145 thereafter 136 145 cerebrospinal fluid 136 150 3 2 5 Potassium Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the c
66. d in Neonatal Intensive Care Units 4 2 What is an ABG An or Arterial Blood Gas is a measurement of the patients pH partial pressure of carbon dioxide and PO partial pressure of oxygen in arterial blood 4 2 1 Why does a Clinician Want an ABG Clinicians most often request an arterial blood gas since it is the e Best indicator of a patients oxygenation status pH PCO and PO e Best indicator of a patients acid base balance and e It assists the clinician in identifying a cardiopulmonary crisis e It assists the clinician in assessing the effectiveness of the patients therapy SSCS AS 4 3 Blood Gas Terminology e Measured Values pH Acid Base Balance Information Carbon Dioxide Partial Pressure Oxygen Partial Pressure SO Oxygen Saturation e Calculated Values Bicarbonate BE Base Excess BEecf Base Excess Extracellular Fluid BEb Base Excess Blood BEact Base Excess at Actual Saturation 4 4 Normal Blood Gas Values e pH 7 35 7 45 pH units e 35 45 mmHg 80 100 mmHG e BE 0 2 mEq L HCO 24 2 mEq L 50 90 100 4 5 Treatment of Abnormal Blood Gas Values e Low PO Need to provide more oxygen to the patient Oxygen range can be Room Air 2196 or 0 21 to 10096 Can simple as providing oxygen rich environment patient breathes on their own Can be as complex as forcing
67. ding blanket like wraps for use in this area e User ID Feature Offers Minimal Security Any operator id will work as long as it is entered twice e Not Menu Driven Operator must memorize functions that keys represent including 02 therapy areas No On Board Printer Printer is separate and must be aligned correctly to transfer data by IR e Sample Testing Process Potential for loss of patient sample due to the way sample is introduced Insert blood into cartridge then place cartridge in analyzer for calibration e Cannot Handle Iced Samples Roche Advantages to Highlight e Room Temperature Storage of Cassette Eliminates logistics nightmares of re labeling expiration dates etc e Automatic Aspiration of Sample Minimizes training time overall easier to use Out of Pouch Stability of 60 Minutes foperator is called away after cassette is opened the cassette is still good Flexible Connectivity Options Rhe OPTR Calibration of Cassette is performed PRIOR to the aspiration of the patient sample Calibration of the cassette is after previous patient QC sample or every thirty minutes whichever comes first and is valid for the next patient QC sample i Stat introduces the blood sample and then calibrates the cartridge if cartridge fails calibration then sample is lost especially important in NICU s where blood is scarce e Extensive Patient Demographic 02 Therapy Entry User can enter 2 information o
68. e cartridge contains the wash solution and also serves as the collection device for all of the waste providing a completely closed bio safe system The Rapidpoint 400 System fully automates the entire testing process to provide standardized laboratory quality testing at every test site It delivers whole blood results in just 60 seconds for one test or a complete panel with the most complete point of care menu available pH blood gas electrolytes glucose and hematocrit all with the capability to be monitored remotely by the central laboratory Rapidpoint 400 uses a zero maintenance cost effective multi use cartridge and auto sampling provides consistent results A color touch screen with icons and video guidance ensures ease of use Rapidlab 800 The Rapidlab 800 System is a fully automated upgradable platform that covers the key critical care whole blood parameters in addition to comprehensive on board information allows the basic blood gas model to be quickly and easily upgraded to include electrolytes metabolites and CO oximetry in a single unit This versatility addresses changing clinical demands by eliminating the need for the laboratory to buy an additional system when only additional testing parameters are needed The Rapidlab 800 Smart Sampler device automatically measure a single sample and makes the system easy to use accurate and safe Maintenance requirements are minimal due to the simple hydraulic design and long l
69. e facilities IT person to generate a parse translator program to act as an interface between the OPTI R and the facilities system SSCS Ai Decision Drivers Connectivity Data interface to the facilities system Additional OPTI R Features to Highlight Connectivity Identify the connectivity options RS 232 hardwire Infrared wireless ASCII ASTM or Mobil ASTM all set at 9600 baud 5 10 7 Hospital Administrators In any hospital the administrators are getting more and more important in the decision making process when new investments are at stake Only a cost benefit analysis will convince them to invest into new instruments The time to send the samples to the central lab run the sample and communicate the result may take up to several hours 5 10 8 Private Hospital Sites When looking at our potential customers the private hospital sector is very promising especially among developing nations In many countries the private sector is less price sensitive has higher budgets and are generally more interested in the latest technological developments in order to offer their patients customers the best fastest and most reliable service possible In many countries the Early adopters for our OPTI R Analyzer will come from this group with its entrepreneurial touch 5 10 9 General Practitioner GP The General Practitioner is not the main target customer for the OPTI R Analyzer Nevertheless there
70. econds which is comparable with the OPTIR Weaknesses e Aspiration Probe needs to be cleaned after every sample Time consuming and potential bio hazardous exposure e Measures via Conductivity Problems with plasma expanders in OR leading to falsely decreased levels Many hospitals have said they have never transfused as many patients e Blood Clots are a problem Noclot catchers Roche Advantages to Highlight e OPTIR is more portable OPTI does not require a seven 7 minute Warm Up time e Directly Measured Radiometer ABL77 The press release dated Copenhagen October 26 2000 shown below is provided as information on the new ABL77 Analyzer RADIOMETER Launches the World s Fastest Portable Blood Gas Analyzer Copenhagen Denmark October 26 2000 The following is an English version of the statement from Radiometer A S to the Copenhagen Stock Exchange labeled Meddelelse nr 11 2000 dated October 26 2000 The statement is made to comply with Danish laws and regulations and is written in Danish We have done our best to provide a fair and honest translation for our many non Danish stakeholders investors employees customers etc to provide the same factual information but it should be emphasized that it is the Danish version for which Radiometer is legally responsible Today Radiometer has released the new blood gas instrument ABL 77 for sales The ABL77 is manufactured by Radiometer s subs
71. ell itself Ninety percent of potassium is concentrated within the cell and damaged cells release potassium into the blood Potassium plays an important role in nerve conduction muscle function and helps maintain acid base balance and osmotic pressure Elevated potassium levels hyperkalemia can be found in oligouria anemia urinary obstruction renal failure due to nephritis or shock metabolic or respiratory acidosis renal tubular acidosis with the K H exchange and hemolysis of the blood Low potassium levels hypokalemia can be found in excessive loss of potassium through diarrhoea or vomiting inadequate intake of potassium malabsorption severe burns and increased secretion of aldosterone High or low potassium levels may cause changes in muscle irritability respiration and myocardial function 3 Siggard anderson Durst RA Maas AHJ IFCC IUPAC approved recommendation 1984 on physicochemical quantities and units in clinical chemistry J clin Chem Clin Biochem 25 369 391 1987 T ss The potassium value obtained may be used to monitor electrolyte imbalance in the diagnosis and treatment of infusion therapies shock heart or circulatory insufficiency acid base imbalance therapy with diuretics all kinds of kidney problems diarrhoea hyper and hypo function of adrenal cortex and other diseases involving electrolyte imbalance Reference Interval Potassium sample type range mmol L whole blood serum a
72. ensity of light reflected back at each wavelength varies in a well defined way with the blood tHb and SO Light Detector LED Lasers Plastic Plastic Pink Overcoat Reflector Fluorescent Sensor Blue Excitation Light Green Fluorescence Light Lens Roche OPTI R March 2000 6 54 The optical signal of the detectors is converted by the microprocessor to a numerical readout in conventional units of measure and displayed on the front of the device Other clinical parameters commonly used for the assessment of oxygen and acid base status are calculated from these measured values 6 5 4 3 The Reusable Sensor Cassette The sensor cassette shown Ca Outlet Port without the syringe adapter allows for direct sample as iration from a capillary or Roche Microsampler The K syringe adapter s are used when sampling from standard N _y 4 syringes Once removed from the Inlet Port storage pouch the cassette must be used within one 1 our or be discarded PCO Valve PO tHb SO pH 6 5 5 Calibration and Quality Control 6 5 5 1 Calibration During the measurement and calibration processes diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette These tests include automatic checks of the cassette for integrity temperature control fluidic control during calibration proper equilibrium behavior of the sensors during ca
73. es light intensity The Roche OPTI R cassette contains a small amount of a known concentration of buffer Light with a known intensity is projected onto the optode Based on the concentration of the buffer the optode fluorescence emits a light of a different intensity This intensity is then compared to the original calibration An unknown sample can then be aspirated into the cassette The intensity of light emitted by the sample is compared to the calibration curve and the analyte concentration is calculated SSS As Why is a humidifier no longer used The OPTI R cassette contains a liquid buffer that is used for calibration verification The evaporated water from this buffer saturates the whole sample path with water vapor This vapor is used to humidify the calibration gas After a patient or QC sample has been measured the cassette is washed using buffer solution contained in the OPTI R SnapPak and the process starts all over again When was the first OPTI Analyzer introduced e The OPTI 1 Analyzer which measured pH PCO2 and PO2 using the same measurement technology as the OPTI R was introduced in 1995 e The OPTI Critical Care Analyzer which measure s pH PCO2 2 tHb 502 and 1 was introduced in 1998 What is the difference between disabling and blanking a parameter Disabling This feature is configured under Setup It allows the administrator to remove parameters tHb SO2
74. g for low reagent and gas as well as battery condition Safety Biohazard waste is contained in the OPTI SnapPak for safe disposal e Maintenance free measurement system e Automatic bubble and short sample detection e Cassette and OPTI SnapPak in place detection 5 8 Positioning Roche offers are broad basket of blood gas and electrolyte analyzers ideal for Hospital Point of Care Testing The Top of the line benchtop system Roche OMNI which supersedes comparable competitive instruments with regard to user interface data management and sensor technology Its parameter panel and its features make the OMNI not only ideal for the laboratory but also for Near Patient Testing sites with high sample volume requirements The modular design however makes the OMNI quite complex which negatively influences its reliability and leads to relatively high maintenance requirements thus compromises its application for POC testing The Roche OPTI R analyzer is ideally suited for use in Hospital Point of Care testing sites as well as a backup instrument in laboratories where sample volumes range from three to twelve samples per day Its design provides operation by minimally trained personnel and requires little maintenance Roche also offers the OPTI CCA Critical Care Analyzer a portable instrument which is ideal for Near Patient Testing in very low volume 1 3 test per days accounts due to the single use cassettes 5 9 Tar
75. get Customers The OPTI R systems will be used in every Hospital Point of Care testing site with low to medium sample throughput ca 3 12 day where portability e g battery operation is required It will also fit into small laboratories where the offered parameter panel is sufficient and no maintenance easy operation and reasonable running costs are important Specifically the following departments within the hospital market will be targeted by the OPTI R Operating Room Emergency Department e Intensive Care Unit e Stat Labs e Main Laboratory OPTR 5 10 Effective Selling Messages 5 10 1 Operating Rooms O R Suites Typical Audience Operators e Perfusionists US Market e Cardiac Surgeons e Anesthesiologists Clinical Interest Typical application of critical care analysis is the monitoring of a patient during surgeries with major blood loss i e open heart organ transplants etc Main goal is to maintain tissue brain oxygenation cardiac and renal function during operation Another goal is to prevent excessive blood transfusions cost by cooling the body down keep very high and if necessary operate with lowest possible tHb 6 8g dl Main Parameters Needed PO2 tHb SO to determine tissue oxygenation oxygen transport function tHb indicator for blood transfusion pH 2 to determine the acid base balance e g respiration kidney renal function nerve and muscle func
76. gh PO values should be analyzed as soon as possible after collection Erythrocyte aggregation and sedimentaton may occur very quickly in syringes containing pathologic blood samples and may adversely affect the measurement of ctHb in any analyzer To prevent such errors first insert the OPTI R cassette into the analyzer to initiate calibration Next mix the syringe sample well by rolling the syringe for at least 60 seconds after expelling any trapped bubbles then immediately measure in the OPTI R The OPTI R system aspirates blood in the same manner from syringes capillaries or the Roche Microsampler No changes are made to the aspiration rate volume or timing Therefore there are no biases or A sss imprecision dependent upon the sample introduction method Sufficient volume must however be present in syringes 0 25 mL in a 1 mL syringe to prevent mechanical interference between the syringe plunger and the OPTI R syringe adapter Errors in blood analysis on properly collected samples may result from improper mixing of the sample after collection and before measurement contamination with room air resulting from failure to expel any trapped bubbles after collection and from metabolic changes in the sample 6 5 8 Handling Steps The Roche OPTI R Analyzer is fast and easy to operate Whenever READY appears on the display the unit is ready to perform a sample measurement READY 19Remain 22NextCal 1 Sample 2
77. he capillary tubes for pH blood gas and electrolyte analysis should not be used for samples taken for the analysis of lithium Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture The puncture should be made deeply enough to ensure a free and rapid flow of blood Do not use clay capped capillary tubes as the rough broken edge left when the capillary is cut may cause damage to the OPTI R cassette fill port Use only capillary tubes with fire polished ends to prevent damage to the cassette If a mixing flea is used as required in some capillary tubes take care to remove the flea prior to sample introduction to avoid damage to the cassette SSCS A sss Specimens collected in capillary tubes are stable at room temperature for up to 30 minutes after collection because of the rapid cooling of the sample accomplished during filling 6 5 7 3 3 Roche Microsamplers Blood may be collected for analysis on the OPTI R with the Roche Microsampler to provide two filled capillary tubes After collection the Microsampler should be capped and transported in a horizontal position to the instrument for analysis within 30 minutes as with all specimens collected in capillary tubes 6 5 7 4 Handling and Storage of Samples Please refer to NCCLS Document C27 A Blood Gas Pre Analytical Considerations Specimen Collection Calibration and Controls
78. he recommends the use of noncolored pH blood gas electrolyte control containing scattering particles for tHb control for routine evaluation of imprecision as a part of an effective quality control program 6 5 6 General Procedure for Measurements All stages of the procedure are menu driven that means the operator is prompted through all steps via the liquid crystal display All user input and response are entered via the numeric keypad or barcode reader when applicable OPTR 6 5 6 1 Calibration Barcode s Each lot of OPTI R cassettes is calibrated during the manufacturing process The calibration is performed using high precision standard solutions and gravimetrically prepared gas mixtures to determine the cassette s measurement characteristics at multiple points within the analyte s measurable range Every cassette package is then labeled with two bar codes A and B which contain this calibration information as well as its lot number and expiration date For each new cassette the cassette s bar code s are read into the analyzer by swiping the cassette package through a conveniently located bar code reader The cassette is then installed and a calibration verification is performed using a precision gas mixture and the cassette s internal storage buffer in a manner similar to other combined blood gas ion analyzers In addition an optical zero point calibration of all optical channels is performed Swiping
79. he sample well prior to measuring on the predicate device 8 2 2 Conducting an Independent Correlation Evaluation Preferred Method This is the preferred method of comparison since it can provide the largest span of blood sample measurement ranges for your data set However additional sample blood material may be required e After measuring the sample on the predicate device expel any air from the sample syringe and cap this sample for later measurement Only after the results have been accepted and reported should this remnant sample be saved for later use e Place these capped samples on the side for later evaluation These remnant samples are now considered waste and can be used for the evaluation purposes e When the desired amount of samples has been collected the remnant samples can then be utilized for the evaluation purposes e Mix each sample by rolling between the palms of your hands and inverting end over end for approx 15 seconds Place the sample to be analyzed on the predicate device and perform the measurement as usual Remove the sample and expel any air in the sample Rhe OPTR e Again mix each sample by rolling between the palms of your hands and inverting end over end for approx 15 seconds Place the sample to be analyzed on the OPTI and perform the measurement as usual e Compare the results between the predicate device and the OPTI Since the samples are remnant and only needed for this correlation
80. he user No Additional Information Acquired Less Critical No Additional Information Acquired e 2000 Typical sample throughput No Additional Information Acquired Important OPTI R features to highlight e Quick Turn Around Time Measured vs Calculated and O2 Saturation Portability e Sample aspiration training analytical reliability Convenient cassette storage at Room Temperature for up to 6 months from date of manufacture e Minimum maintenance requirements Additional information No Additional Information Acquired Decision Drivers e Quick results Ease of Use e Measured versus calculated O2 saturation results Accuracy Additional OPTI R Features to Highlight e Quick TAT Turn Around Time Physicians want immediate results during cath procedures in order to benchmark their progress Measured versus Calculated tHb and O2 saturation Results provides physicians with extremely accurate results for their procedures Portability of the OPTI R Makes it easy for the nursing staff in transporting the instrument from room to room in the cath lab e Auto Aspiration Features Staff in this area is very busy hih level of interest in time saving features e Ability to Standardize to One 1 Instrument for both Blood Gas and ox tHb and O2 saturation needs Standardization to one 1 vendor results in overall cost savings 5 10 4 Small Laboratories Typical Audience Operators
81. hemolysis Lipemia equivalent to 3000 mg dL triglycerides Elevated white blood cell count 30 000 WBC uL The following substances were tested in plasma at the NCCLS recommended test level or higher and showed no interference to blood gas and electrolyte analytes Coumadin Warfarin 12 mg dL Dicumarol Dicoumarin 11 mg dL Procain Novacaine 13 mg dL Acetaminophen Paracetamol 20 mg dL Fetal hemoglobin taken from cord blood extracts was tested and showed no interference to the tHb and SO measurement The following interferents were quantified in whole blood showing sensitivity to dyes similar to most CO oximeters Substance Amount ctHb SO change g dL change 96 EXOGENOUS Cardio Indocyanine Green 0 5 mg dL 4 7 4 Evan s Blue 5 0 mg dL lt 1 17 Methylene Blue 25 mg dL 3 0 37 ENDOGENOUS Carboxyhemoglobin 1090 2 0 lt 2 Carboxyhemoglobin 2096 3 3 296 Methemoglobin 2090 44 5 7 The following exogeneous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver ee A NOTE all showed negligible interference to and Substance amount pH Na mmol L K mmol L change change change change Sodium fluorescein unstable unstable 0 8 unstable 25 mg dL Cardio indocyanine 0 02 15 0 4 0 01 green 0 5 mg dL Methylene blue unstable unstable
82. idiary SenDx Medical Inc in Carlsbad California The instrument is a further development of the Rhe OPTR ABL70 which SenDx had developed prior to Radiometer s acquisition of the company in 1998 The ABL77 has significantly improved software and measures on half the blood sample Through the cooperation between SenDx Medical Inc and Radiometer Medical A S the instrument has been made more user friendly and reliable With the ABL77 Radiometer offers the hospitals a quick and reliable blood gas instrument which is portable and designed for use near the patient everywhere in the hospital Such instruments are called Point of Care instruments The attached press release will today be forwarded to the press Copenhagen October 26 2000 RADIOMETER A S Johan Schroder President CEO Contact Johan Schr der Tel 45 3827 3371 Press Release RADIOMETER Launches the World s Fastest Portable Blood Gas Analyzer Radiometer s product company SenDx Medical Inc in California has today released a new blood gas analyzer specially developed for use in patient wards The ABL 77 makes it easy for the nursing staff to measure important acute parameters in blood samples from critically ill patients The new ABL77 blood gas analyzer provides accurate results in approx one minute making the portable analyzer the world s fastest of its kind Compared to most other portable blood gas analyzers in the market the ABL77 is always ready for mea
83. ient demographics available Measuring To Input XXX Pat Data press ENTER NOTE You may also press the left arrow key when this display appears to recall the patient information that was entered during the previous patient sample Then press ENTER to edit this information NOTE Parameter blanking may also be available depending on the analyzer configuration under Setup See the OPTI R Operator s Manual for parameter blanking and disabling under Setup 20 6 When the analysis is completed the status light stops blinking and the instrument alerts you that the measurement has been completed with a At this time you may continue entering or editing the patient information until you have completed or display the results immediately by pressing lt ESC gt at any time pH PCO2 202 7 388 44 6 146 9 0 8 NOTE Ifthe keypad has not been touched for approximately three 3 minutes the results will automatically be displayed 7 The 4 column displays the calculated parameters By pressing the lt or gt keys all calculated parameters can be viewed NOTE If patient temperature was input it will be displayed in place of a calculated parameter In this case the blood gas values displayed are temperature corrected NOTE The calculated parameter first shown with the result may be configured in the setup menu See the OPTI R Operator s Manual for configuration under Setup 8 Press
84. ife Ready Sensors 7 2 4 i STAT http www i STAT com Corporate information collected via the internet and or other i STAT Corporation sources and is subject to change Roche OPTR Mission i STAT Corporation s mission is to improve the quality and reduce the cost of health care by providing products that improve the process of patient care y Company Profile Technology A recognized leader in point of care blood analysis products i STAT s proprietary core technology provides a revolutionary method of blood analysis The Company has developed the world s only fully automated pocket size analyzer which performs a complete panel of the most commonly ordered blood tests in a simple procedure at the point of patient care i STAT has combined established principles of electrochemistry with micro fabrication process technology from the semiconductor industry to create this revolutionary breakthrough Products The Company introduced its first product the i STAT System into the US acute care hospital market in mid 1992 Designed for use at the point of patient care the system consists of two components 1 a handheld microprocessor based analyzer and 2 disposable test cartridges which contain an array of biosensors microfabricated onto silicon chips A comprehensive data management system ensures all test results are seamlessly integrated into any laboratory or clinical information system Overview The i STAT S
85. ing chamber is carefully thermostated Blood analysis is does not begin until the temperature has been reached and is stable The OPTI R Analyzer has automatic sample aspiration How does the competition compare with this The OPTI R is the only point of care instrument that contains an automatic sample aspiration feature Other point of care competitive systems require an injection or positive pressure method of sample insertion resulting in a potential for blood spillage and contributing to an overall technique dependent testing process Can I run two different quality control materials interchangeably on the OPTI R Yes but the OPTI will not store the results in its QC database and will therefore neither calculate nor print any QC statistics Can I run OPTI check as a patient sample Yes however the results will not be stored in the QC database and the results for tHb and SO2 will be suppressed since the analyzer knows it is not running a whole blood sample What is the analysis methodology used by the OPTI R Analyzer e Optical Fluorescence for the direct measurement of pH PCO2 Nat K and Ca e Optical Reflectance for the direct measurement of tHb and 502 Is this a new methodology The methodology is based on the experienced reliable and well excepted optical sensor technology Why isn t a reference electrode utilized in the OPTI R Analyzer In the fluorescence method the OPTI R measurement chang
86. ing the measurement 1 1 1 The pH optode measurement principle is based upon pH dependent changes of the luminescence of a dye molecule immobilized in the optode Such pH indicator dyes have been used by chemists for many years to perform acid base titrations in turbid media The relationship of luminescence to pH is quantified by a variant of the Mass Action Law of chemistry which describes how the fluorescence emission intensity increases as the blood pH is increased above the dye s characteristic pKa pH optodes do not need a reference electrode to measure pH However they exhibit a small sensitivity to the ionic strength of the sample being measured lo Ls133102995 The PCO optode measurement principle is based upon placing a pH optode behind an ion impermeable membrane just as conventional PCO blood gas electrodes employ the Severinghaus CO electrode construction As such PCO optodes suffer from non selective interference from volatile acids and bases in blood just as conventional electrodes The K and Ca ion optodes are based upon the principle of Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion co
87. int for oxy and carboxyhemoglobin Sensitivity to erythrocyte aggregation rouleau formation is minimized by maintaining high shear force just prior to measurement see Interferences Range 650 nm 870 nm Laser Diode Isobestic point 803nm O Hb HHb 640 690 740 790 840 Wavelength nm 6 5 4 2 Operation The OPTI R Analyzer is a microprocessor based instrument measuring optical fluorescence The sensor cassette contains the sensors storage buffer and a valve to control the fluid flow After reading the calibration information specific to a cassette into the instrument by swiping the cassette package through a convenient bar code reader the cassette is placed in the sample measurement chamber The analyzer warms the cassette to 37 0 0 1 and then performs a calibration verification on the sensors for PCO and PO by passing a gas mixture across the optode sensors The pH and ion channels are calibrated with precision buffer solution contained in both the sensor cassette and the OPTI R SnapPak The tHb and SO channels if configured are factory calibrated When calibration is verified the analyzer is ready for sampling During a measurement the analyzer aspirates the blood sample into the cassette and over the optode sensors and measures the fluorescence emission of the optodes after they have equilibrated with the blood sample After each measurement the sample is washed out with buffer from the fluid pac
88. iod using two OPTI R systems with two replicates per run using a commercially available solution of reduced bovine T ss hemoglobin which has been demonstrated to be comparable to tonometered whole bloo The OPTI R system is designed to measure whole blood serum or plasma to be controlled with aqueous solutions Aqueous controls are portable and quite convenient to use with the OPTI R system however their low oxygen carrying capacity and temperature sensitivity is well known Measurements of such materials are more prone to pre analytic error as well as analyzer specific errors compared to similar measurements of whole blood The OPTI R system is no exception to this and demonstrates somewhat poorer precision with aqueous controls than with whole blood due to the large amount of plastic material comprising its disposable measurement chamber The OPTI R Analyzer s tHb measurement is sensitive to pathologically rapid sedimentation rates of the erythrocytes often induced by excessive rate and amounts of rouleaux formation P This is observable as rapid sedimentation and clarification due to erythrocyte aggregates falling to the bottom of the syringe within minutes of mixing The OPTI R Analyzer breaks up most of the rouleaux and other aggregates by rapidly aspirating the whole blood sample with high shear rate however in rare pathologic cases the rouleaux aggregates persist or reform during the aspiration and cause a positi
89. irst acid base analyzers in 1954 Ever since RADIOMETER has continued to innovate RADIOMETER blood gas analyzers combine durability ease of use and minimal maintenance with the highest level of measuring accuracy A full range of analyzers covers everything from basic needs to the most comprehensive parameter combination RADIOMETER also offers a full program of support services including individually tailored training courses for doctors nurses and laboratory staff This ensures optimal use of the equipment RADIOMETER has a world wide sales and service support network ready to help in more than 100 countries around the globe Radiometer ABL70 The ABL70 analyzer has been designed to meet special needs for near patient applications such as intensive care emergency operating rooms and cardiovascular surgery The ABL70 combines the cost savings and accuracy Roche OPTR known from benchtop analyzers with the speed and convenience of a bedside device Broad Array of Parameters The ABL70 provides a broad and flexible menu of pH blood gases electrolytes and hematocrit The panel of 7 parameters is measured in less than 60 seconds Always Ready to Measure Compared to single use cartridge devices there is no cartridge preparation calibration or temperature stabilization prior to the measurement because the ABL is always ready to measure Shortest Start up Time The ABL70 has the shortest start up time of any multi
90. ith the corresponding RA number and shipped together with the completed RA form to the respective repair centre Roche Diagnostics Corporation Roche Diagnostics GmbH 235 Hembree Park Drive Hans List Platz 1 Roswell Georgia 30076 1447 A 8020 Graz USA Austria 9 1 3 Local Instrument Repair Service Training The Global System Supports in Graz and Roswell are offering service trainings according to the training schedules which can be found in the INTRANET in the near future Trainings are organized according to the train the trainer concept Successful participation is documented with a certificate which authorizes trainings of technical service staff locally Depending on your needs and economical reasons as well traveling costs number of participants etc a training class can be held in Roswell or other locations as deemed necessary 9 1 4 Service Manual Technical information is provided in the OPTI R Service Manual English which is available under Roche Reference Number 03077039001
91. ity systems group a marketing group a field sales consulting and implementation staff and other corporate support functions such as finance and accounting information systems and human resources The corporate offices are located in East Windsor NJ and accommodates the finance group clinical and technical services customer support distribution and research and development laboratories and other corporate functions The corporate facility also includes an instrument the handheld analyzer engineering and assembly unit A technology and manufacturing facility is located in Kanata Ontario Canada a suburb of Ottawa and includes research and development laboratories a wafer fab and three cartridge assembly production lines uoneIngyuo 1e ndod soy x cO cO Ss2oxg 9524 Ss2oxg aseg 9pIXo q oL 8 ayeuoqiesig paeme osoon r Hd 70 Pozo esoon o opuo q Hd osoon r urnissejoq urnissejog urnissejog urnissejog urnissejoq S1ojoure1ed esoon o umnrpog umnrpog poinseojq oL oL
92. k and a one point calibration is 20 performed using the calibration gas and the buffer from the OPTI R SnapPak The blood samples are safely locked away in the waste pouch of the OPTI R SnapPak During each measurement light originating from lamps in the analyzer is passed through optical filters so that photons of a specific color are transmitted to the sensors causing them to emit fluorescence The intensity of this emitted light depends upon the partial pressure of oxygen PO carbon dioxide PCO hydrogen ion concentration pH or electrolyte concentration K of the blood in direct contact with the sensors as described above The light emitted by the fluorescent sensors is measured by the analyzer after passing through lenses and additional optical components A filter is used to isolate specific colors of interest from this returning light for measurement by a light detector Plastic Plastic Optical Isolator Blue Excitation Light Fluorescent Sensor Lens Green Fluorescence Light vov For tHb and SO red and infrared light from three laser diodes is directed via dichroic beamsplitters and optical waveguides onto and through an optically polished window to the blood in the cassette over the sensor This light is partially absorbed and reflected by the erythrocytes and sensor overcoat back up into the instrument traveling via an optical waveguide to a photodiode The int
93. lation As always the first concern before utilizing patient samples for a study is to provide accurate and acceptable results to be reported to the facility After which the results and or the remnant samples may be used for conducting this study 8 2 1 Using Results from the Reported Measurement e To ensure the most accurate and best correlation between the two devices always mix the sample well for approx 15 seconds by rolling between the palms of your hands and inverting end over end before placing on the predicate device After measuring the sample on the predicate device expel any air from the sample syringe and cap this sample for later measurement on the OPIT Analyzer Only after the results have been reported and accepted should this sample be used for correlation purposes This will ensure adequate sample material to provide the patient results to the facility e f not immediately performing the second measurement place these capped samples on ice Samples may be kept on ice for up to 1 hour Before mixing the sample on the OPTI Analyzer mix the sample well for approx 15 seconds by rolling between the palms of your hands and inverting end over end This will ensure an accurate tHb SO2 measurement on the OPTI Analyzer DO NOT PLACE THE SAMPLE ON THE OPTI UNTIL YOU ARE PROMPTED Compare the results between the predicate device and the OPTI NOTE ensure the most accurate results and best correlation always mix t
94. ld not be used Lithium heparin should not be used for samples taken also for analysis of lithium 3 5 2 1 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the amount of blood required to minimize the effects of dilution of the blood by the anticoagulant solution Although plastic syringes are commonly used for collection of blood specimens for blood gas analysis there have been reports in literature regarding the use of plastic syringes when values higher than normal are expected Particular attention should be paid to cooling blood samples in ice water because of the CO and oxygen solubility in some plastics If blood specimens are expected to have very high PO values care should be taken to analyze the specimen as quickly as possible following collection to avoid the need for cooling Attention should be paid to thorough mixing of whole blood samples prior to analysis since sedimentation of blood cells affects the measurement of total hemoglobin 3 5 2 2 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume filled of 125 uL The Roche Capillary Tube Roche Reference Number 03113477180 is ideally suited with a volume filled of 200 uL The Roche capillary tubes for pH blood gas and electrolyte analysis should not be used for samples taken for the analysis of lithium Samples may be collected in
95. libration and measurement automatic detection of bubbles and short sample during aspiration and automatic detection of low gas low battery dirty optics or worn pump conditions Calibration of the tHb channel is required every 3 months This calibration is performed using the Roche tHb Calibration Cassette in a manner similar to other instruments that measure tHb and or hemoglobin derivatives optically The tHb calibration verifies the measurement optics and electronics and corrects any potential drift A second HbCal option is available on the OPTI The HbCal LastBlood option allows the OPTI to be correlated to another tHb measurement method When the LastBlood is run the OPTI R will compensate for any measurement bias allowing any future measured samples to match the alternate device For more information including detailed instructions on the HbCal options see Section 6 3 Quarterly Maintenance in the OPTI R Operator s Manual 20 6 5 5 2 QC Overview The intent of a Quality Control program is to assure reliable patient values over the clinically significant ranges for all the measured parameters The program should involve the total process of specimen collection preparation and results analysis reporting and interpretation and the training of personnel involved in all of these processes A Quality Control program for blood gas analysis includes the analysis of materials with known values or ranges
96. ll OPTI products including the OPTI CCA and OPTI 6 Technical Features 6 1 OPTI R Critical Care Analyzer The Analyzer in brief The OPTI R Critical Care Analyzer is intended to be used for the measurement of pH PCO and 50 in samples of whole blood and pH K and in serum and plasma in either a traditional blood gas Point of Care locations or clinical laboratory setting by personnel minimally qualified to perform and report these results 6 2 Brand Names OPTI R is the current brand name of the analyzer With regard to the Roche Design Guidelines the brand name will be changed to Roche OPTI R in Quarter II 2001 earliest Therefore I hope you understand that we use the new brand name in advance here WZ H3MOd 318VO 2610X 318Vv2 210X3 dO SASN 39vxOvd SYNLVYSLI 900 18 140 31VOl3ILH3O LH3SNI 2 0 1 OLL6 38OHd LATALS 00S VA AINT 6 380S019 50 3H SV Id LVN IW 001 11O8 98009IN 1 ZL ZOOOOW 140 H3lNlHd HL HadVd 02004 dO ADVLIOA HMd 5 NMOGLNHS 31L3SSVO LLLZ2d8 NMOGLNHS 5IOVd 011 99 Gaaia1dWOO ASSY 100448 Buipnjour OIM3N39 L12d8
97. lways ready for patient analysis e Uniform sample aspiration makes sample introduction operator independent e Sample aspiration reduces training requirements only few hours needed e Direct sampling from standard syringes capillaries and Roche Microsampler e Convenient cassette storage at room temperature 6 months from date of manufacture at 4 30 C 39 86 F e Maintenance free optical system e Light weight and easy to transport with built in handle Power supplied by either or rechargeable battery SSCS AS e Multi lingual software English German French Spanish Italian Japanese and user interface e Flexible set up functions to accommodate user preferences Password protected system configuration menus Wireless data download via infrared data port Accuracy and Precision e Results comparable to reference benchtop analyzers sensor cassettes have a six point factory calibration for all analytes e Full 1 point gas calibration for PO2 and PCO2 after each sample measurement or minimally at 30 minute intervals e Uniform sample aspiration assures consistent results avoiding sampling technique dependent errors e On board quality control program stores 1 month of QC results at three 3 levels and statistical report User programmable reference ranges with auto alerts Self diagnostic program Storage for gt 150 patient results Fully automatic tracking barometer for accurate blood gas results Cle
98. mables Bayer Diagnostics Chiron http 1 5 http www i STAT com Sample Range Conclusion Conducting A Field Test Correlation Using Results from the Reported Measurement 2 2 Conducting an Independent Correlation Evaluation Preferred Method 23 Special Thoughts and Considerations SERVICE CONCEPT ROCHE OPTI R ANALYZER Service Aspects 11 General 12 Instrument Repair 1 3 Local Instrument Repair Service Training 1 4 Service Manual 1 Introduction Dear Colleagues Roche is proud to announce the availability of the new Roche OPTI R Critical Care Analyzer The Launchbook which contains important marketing strategic selling and technical product information is designed to maximize your sales and marketing activities for this product The Roche OPTI R Critical Care Analyzer Launchbook contains a Table of Contents that will guide you in locating information pertaining to specific topics such as Product Positioning Competition SWOT Analyses and Saentific Evidence etc Our goal is to provide you with the tools that will allow you to demonstrate to your prospects and customers why Roche is the leader in the Hospital Point of Care market We are convinced that the superior technology and ease of use of the Roche OPTI R Critical Care Analyzer make this instrument ideally suited for the stat blood gas electrolyte market With the availability of the Roche OPTI R Analyzer Roche is able to
99. memory functions The buffer capacity of the OPTI allows for 7150 patient results to be stored in memory along with all pertinent patient demographics which were entered during the measurement The buffer capacity of the OPTI R allows for 1 month of three 3 levels of quality control data to be stored in memory The buffer capacity of the OPTI R allows for 150 patient ID s and 150 associated 4 digit PIN numbers to be stored in memory 6 6 2 1 Overall Test Time Time To Result after sample aspiration Approximately one 1 minute to one 1 minute and fifteen 15 seconds after sample aspiration Wash and Calibration Approximately two 2 minutes Overall Cycle Time Approximately three 3 minutes to three 3 minutes and fifteen 15 seconds 6 6 2 2 Using Patient Identification Numbers Patient identification numbers ensure an unambiguous identification of results and patient samples The OPTI R Analyzer is designed for entering patient identification numbers referred to as Pat IDs in the following The entry may be set to optional or required which means this function may be enabled in the setup menu if required A numerical Pat ID may be entered either directly on the instrument using the numeric keypad on board bar code reader or by means of an optional external bar code wand connected to the port on the rear of the instrument The length of the Pat ID may be entered in a range of 1 and 15 A Pat ID may be entered
100. ncentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion Like the pH optode the ion optodes do not need a reference electrode however several of them do exhibit a small pH sensitivity which is automatically compensated in the Roche OPTI R using the measured pH The measurement of total Hemoglobin tHb and oxygen saturation SO uses the well established principle of optical reflectance Red and infrared light at three wavelengths is directed at whole non hemolyzed blood within a precisely defined part of the cassette over the optode The photons are partially absorbed and reflected by erythrocytes in a manner proportional to hemoglobin level at low hemoglobin levels the unabsorbed photons strike the optode s pink overcoat and are reflected back up through the blood a second time A portion of the reflected light exits the top of the cassette and 20 is measured by detector in the instrument The infrared wavelengths selected for the hemoglobin measurement because they are largely independent of SO that is the predominate forms of adult and fetal hemoglobin absorb similarly within the 750 850 nm wavelength range The red wavelength is utilized for the SO measurement because it is much more strongly absorbed by deoxyhemoglobin than all other hemoglobins and it is picked close to the isosbestic po
101. ncies The OPTI Method Sheet included in the front section of the OPTI R Operator s Manual provides precision and recovery data for all the measured parameters in the ranges that are usually encountered in the diagnostic testing of patients Should a laboratory wish to perform a calibration verification for measurement values outside the broad range Roche suggests tonometry of whole blood for PO2 and correlation against flame photometry for electrolytes correlation against cyanmethemoglobin method for tHb and blood pH correlation with conventional blood gas analyzers 6 5 5 5 QC Recommendations Policies regarding the measurement of QC samples are established by the individual hospital Roche recommends that QC solutions be run as a minimum with each new cassette and once every shift or every 24 hours thereafter You should use only Roche recommended controls such as OPTI check which do NOT contain dye or other colored material Whenever a new lot of controls is opened be sure to enter the lot number information into the analyzer as described in Chapter 3 Customization of the OPTI R Operator s Manual These materials should provide target values for pH and all other measured parameters over a range of measurement values typically seen in each testing site laboratory The results obtained should fall within limits defined by the day to day variability as measured in the user s laboratory facility Roc
102. nd Electrolyte Testing 2001 2001 2002 2003 2004 2005 2006 SSCS 2000 5 3 2 Point of Care Testing US Hospital Survey Many surveys and evaluations have been conducted in the context to POCT A US hospital survey identified the most important advantages provided by POCT as seen by clinicians and lab personnel Advantages 96 Turnaround Time 91 Patient Satisfaction 34 Length of Stay 21 Visibility 17 Cost Reduction 15 Backup 14 Personnel Requirements 9 Bickford 1994 Clinics Lab Med 14 623 5 4 Why Point of Care testing Clinicians are less and less willing to accept turn around times clinical TAT time from order to treatment of more than 5 min for critical care analytes STAT labs have been created to reduce TAT but on the other hand they have been labeled to be very expensive to maintain This is mainly caused due to additional personnel and equipment cost Clinicians feel that reduced TAT leads to more effective patient care and or better patient out come which in turn saves cost total time from diagnosis to treatment to disposition Lab people tend to not agree to clinicians perception of long TAT Labs tend to define TAT as time between collection to reporting which in many cases is less than 5 min Nevertheless it is important that Laboratory Testing and Point of Care Testing are complementary The clinicians should define the needs and preferences and the laboratory should propose the dx infra
103. nd plasma new born 3 7 5 9 infant 4 1 5 3 child 3 4 4 7 thereafter 3 5 5 cerebrospinal fluid 0 70 plasma level fraction 2 5 3 2 rises with plasma hyperosmolality 3 2 6 lonized Calcium Calcium in blood is distributed as free calcium ions 5096 bound to protein mostly albumin 4096 and 1096 bound to anions such as bicarbonate citrate phosphate and lactate However only ionized calcium can be used by the body in such vital processes as muscular contraction cardiac function transmission of nerve impulses and blood clotting The OPTI R Analyzer measures the ionized portion of the total calcium In certain disorders such as pancreatitis and hyperparathyroidism ionized calcium is a better indicator for diagnosis than total calcium Elevated calcium hypercalcemia may be present in various types of malignancy and calcium measurements may serve as biochemical markers In general while ionized calcium may be slightly more sensitive either ionized or total calcium measurements have about equal utility in the detection of occult malignancy Hypercalcemia occurs commonly in critically ill patients with abnormalities in acid base regulation and losses of protein and albumin which gives a clear advantage to monitoring calcium status by ionized calcium measurements Patients with renal disease caused by glomerular failure often have altered concentrations of calcium phosphate albumin magnesium and pH Since these conditions tend t
104. ng of extra battery pack for the OPTI R Analyzer Each chardger contains a power supply with circuitry Input voltage 110 VAC 47 63 Hz The following battery charger which has to be ordered separately can be used Roche Diagnostic Corporation 235 Hembree Park Drive Roswell Georgia 30076 Roche Reference Number 03104320001 6 6 4 2 Battery Charger 220volts For fast charging of extra battery pack for the OPTI R Analyzer Each charger contains a power supply with circuitry Input voltage 220 VAC 47 63 Hz Rhe OPTR The following battery charger which has to be ordered separately can be used Roche Diagnostics Corporation 235 Hembree Park Drive Roswell Georgia 30076 Roche Reference Number 03104303001 6 6 4 3 External Barcode Wand The following External Barcode Wand which has to be ordered separately can be used Roche Diagnostics Corporation 235 Hembree Park Drive Roswell Georgia 30076 Roche Reference Number 03133516001 If connecting a bar code reader to the OPTI R Analyzer other than the type described above data transmission problems may occur 6 6 4 4 Cable Interface OPTI R Analyzer to PC The following Cable Interface OPTI R Analyzer to PC which has to be ordered separately can be used Roche Diagnostics Corporation 235 Hembree Park Drive Roswell Georgia 30076 Roche Reference Number 03133524001 6 6 5 Data Manager PC Connection It is possible to connect a Host P
105. nly on O2 Therapy Screen e Bar Code Scanner Capability Number one source of error with i Stat is incorrect patient id entry e Direct Measurement of tHb HCT via conductivity is a major source of problems in the OR i Stat Position Roche Response POSITION Other instruments are too large to be considered true Point of Care Roche RESPONSE The OPTI R Critical Care Analyzer has the flexibility of being utilized in the battery mode for portable use as well as the AC mode for more stationary use No need to purchase additional lithium batteries No risk of loss due to small size POSITION It only takes a few drops of blood to perform a patient test Roche RESPONSE This is true for electrolyte analysis however for blood gas testing you must have a minimum of 130 1 of blood Also after implementation i STAT recommends obtaining extra blood for pre analytical drop onto a gauze pad for optimum results POSITION The i STAT System has no maintenance requirements Roche RESPONSE The OPTI R s maintenance requirements are minimal Demonstrate that our maintenance can easily be performed by both nursing and OR personnel POSITION The i STAT System interfaces to any HIS LIS via an off the shelf product Roche OPTR Roche RESPONSE The i STAT Central Data Station can be interfaced to all HIS LIS however all interfacing requires the presence of i STAT hardware Interfacing to other Point of Care instruments ca
106. nnot be easily performed and in many instances is impossible Emphasize the flexibility and capabilities of the OPTI R Critical Care Analyzer 7 2 5 Diametrics Agilent HP http Diametrics com Corporate information collected via the internet and or other Diametrics Corporation sources and is subject to change POINT OF CARE SYSTEM IRMA SL Blood Analysis System Mission It is the mission of Diametrics Medical Inc to transform the process of critical care Diametrics is accomplishing this through the dynamic integration of two world class technologies with the need of health care professionals to provide high quality care to critically ill adult pediatric and neonatal patients Diametrics continually strives to raise the standard of care by Expanding product applications of both the continuous monitoring and point of care testing technologies forging strategic manufacturing and distributor partnerships enhancing company performance It is through this mission of dynamic integration that Diametrics Medical will achieve its strategic intent to be The World Leader in Critical Care Blood and Tissue Analysis Systems Electrochemical Technology Point of Care Testing Products The cornerstone of our electrochemical technology is the IRMA SL Blood Analysis System This point of care testing system is a small portable integrated workstation that allows clinicians to test at the bedside and immediately receive results for
107. nticoagulant to prevent the sample from clotting DO NOT use anticoagulants such as EDTA citrate oxalate etc Use only heparin salts as anticoagulants NOTE Sedimentation of red cells may occur rapidly in whole heparinized blood This may effect your tHb results Make sure your sample is free of trapped gas bubbles and completely mixed by rolling the syringe between the palms of your hands and inverting end over end for at least one 1 minute just prior to sample introduction NOTE Always follow proper safety procedures when handling biological samples 3 6 Marketing of the Roche OPTI R Critical Care Analyzer The OPTI R Analyzer and cassette will be available from March 1 2001 on and will fill an existing gap in the Roche critical care product portfolio The OPTI R Analyzer is designed mainly for decentralized use in hospitals The Operating Room will be the first choice customer because in the OR a rapid result and ease of use is mandatory to effectively manage the critical condition of these patients The OPTI R Analyzer will also be used in other Point of Care environments with low to medium sample throughput ca 3 12 day where portability e g battery operation is required It will also fit into small laboratories where the offered parameter panel is sufficient and no maintenance easy operation and reasonable operating costs are important Specifically the following departments within the
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109. o change ionized calcium independently of total calcium ionized calcium is the preferred method of accurately monitoring calcium status in renal disease Ionized calcium is important for diagnosis or monitoring of hypertension management parathyroidism renal diseases malnutrition kidney stones multiple myeloma and diabetes mellitus Roche OPTR Reference Interval Ionized Calcium sample type range mmol L whole blood Hep adult 1 12 1 32 plasma Hep adult 1 03 1 23 serum adult gt 18 yr 1 16 1 32 1 18 yr 1 20 1 38 3 2 7 Total Haemoglobin concentration tHb The haemoglobin is the main component of erythrocytes It serves as the vehicle for transportation of oxygen within the bloodstream and each gram of haemoglobin can carry 1 39 mL of oxygen The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells RBC because some red cells contain more hemoglobin than others Although oxygen transport is the main function of hemoglobin it also serves as an important buffer in the extracellular fluid Decreases in the amount of hemoglobin can come about as a result of a decreased concentration of hemoglobin in the erythrocytes or a decreased number of erythrocytes that contain a normal concentration of hemoglobin Decreased levels are found in anemia states hyperthyroidism severe hemorrhage and hemolytic reactions due to transfusi
110. of expected values and the comparisons of the results from the analyzer with these values This program allows the analytic performance of a laboratory to be evaluated and documented An effective Quality Control program should include e Evaluation of precision over the entire analytical range e Anassessment of failure modes and their effects and means of management throughout the process e Simple statistical calculations which provide a means of assessing precision Control charts or graphs which contain warning limits to assist the technical staff in the evaluation of results A clear set of guidelines to assist the staff in determining if patient results are acceptable A clear set of corrective actions to be taken in out of control situations 6 5 5 3 Quality Control On initial use of a new cassette validation should be performed by analysis of Roche Roche blood gas electrolyte tHb and SO controls Roche OPTI check or other equivalent material which has been recommended by Roche This material should provide target values for pH PCO PO Na tHb and SO over a range of measurement values typically seen in each laboratory The results obtained should fall within limits defined by the day to day variability as measured in the user s laboratory Additionally it is recommended to run two levels of OPTI check controls every shift or at a minimum every 24 hours It is recommended to
111. ons of incompatible blood reaction to chemical infectious and physical agents as well as various systemic diseases Increased levels are found in hemoconcentration of the blood chronic obstructive pulmonary disease and congestive heart failure tHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data tHb is used to screen for disease associated with anemia to determine the severity of anemia to follow the response to treatment for anemia and to evaluate polycythemia Reference Interval Total hemoglobin sample type range g dL whole blood female 11 5 16 1 male 12 0 17 4 new born 13 4 19 8 T 3 2 8 Hemoglobin Oxygen Saturation SO2 When each heme group of the hemoglobin molecule is associated with one molecule of oxygen the hemoglobin is referred to as oxyhemoglobin O2Hb The amount of oxyhemoglobin expressed as a fraction of the total functional hemoglobin able to bind oxygen is termed hemoglobin oxygen saturation 5 96 The largest portion about 98 of blood oxygen content is the oxygen bound to hemoglobin The reference interval for arterial blood from healthy adults is typically 94 to 98 Decrease in SO below the critical level necessary for tissue oxygen saturation is a grave clinical situation Low oxygen saturation may be caused by many of the same factors responsible for arterial hyp
112. oxemia Low fractional oxyhemoglobin FO Hb defined as a fraction of total available hemoglobin may also be caused by unusually large amounts of non functional hemoglobins high concentrations of deoxyhemoglobin chemically altered hemoglobin or factors affecting the affinity of hemoglobin for oxygen including temperature PCO 2 3 DPG concentration and type of hemoglobin Reference Interval Oxygen Saturation sample type range 96 whole blood arterial new born 40 90 thereafter 95 100 3 3 Limitations The performance characteristics are affected by the following sample considerations The preferred test liquid is whole human blood for all parameters It is necessary to tonometer blood to obtain values to evaluate accuracy of PO and because patient samples must be considered to be unknown Tonometry of blood introduces potential errors unrelated to the blood gas system being evaluated Accuracy of the gas values used temperature control and thermostatting of the tonometer humidification of the tonometry gases duration of tonometry and transfer of the sample from the tonometer to the instrument for analysis are examples of potential pre analytical error pH of blood cannot be predicted in tonometry All tonometered samples analyzed in these studies were analyzed in duplicate on an Roche AVL 995 to establish correlation Precision of PCO and PO measurement as well as pH was evaluated over a 20 day per
113. p technology is excellent 7 2 3 Bayer Diagnostics Chiron http www Bayerdiag com Corporate information collected via the internet and or other Bayer Diagnostic Corporation sources and is subject to change Vision Bayer is committed to changing the world with great care Our vision is to be a leader in the markets we serve and to be a major contributor to our worldwide parent company We will achieve our Vision through a diversified highly motivated work force by satisfying and retaining loyalties of our external and internal customers with an organization that fosters teamwork and is unencumbered by bureaucracy by being environmentally responsible and by being good corporate citizens in the communities in which we work and live Company Profile About Bayer Diagnostics Bayer Diagnostics is one of the largest and fastest growing medical diagnostics businesses in the world Eight thousand employees touch the lives of five million patients daily in more than 100 countries worldwide Bayer designs manufactures and markets clinical diagnostics systems for the major industry markets of Self Testing Near Patient Testing Hospital Point of Care and Critical Care Laboratory Testing and Nucleic Acid Diagnostics The company has more than 50 branch offices seven major manufacturing plants and an extensive global distribution network Bayer Diagnostics is a part of the worldwide Bayer Group a 29 billion international life sciences
114. panel configurations that include pH PCO2 PO2 activated clotting time ACT glucose lactate creatinine sodium potassium chloride ionized calcium urea nitrogen BUN hematocrit and various calculated parameters The testing process is contained in a single use disposable cartridge that self calibrates miniaturized sensors upon use The unique technology also eliminates maintenance and reduces the complexity of performing quality control Just 2 3 drops of fresh whole blood is all that is required and the portable battery powered analyzer displays quantitative test results in just over 2 minutes The i STAT System is currently in use in more than 2000 hospitals in the United States Strategy The Company s strategy is to become the standard of care for stat blood analysis at the patient s side Its current product offering directly addresses a 3 0 billion segment of the worldwide US 19 billion in vitro diagnostic market Continued technology product development and penetration of additional markets both international and domestic will create continued growth and expansion of i STAT In the US the i STAT System is currently used in over 2000 hospitals to perform critical blood analyses The Company s larger US customers have implemented the i STAT System throughout all of their critical care departments and are using it as their principal means of performing stat tests Distribution amp Strategic Alliances In September 1998 i
115. ple test analyzer When installing a new sensor cassette the analyzer is ready for testing in about 7 minutes Virtually Maintenance Free There are just two consumables a multiple test sensor cassette and a calibration pack which contains all solutions and a waste reservoir Both are easily and quickly installed Intuitive Touch Screen Operation The combination of the color touch screen and customizable menus makes the user interface intuitive and easy to use Everyone can use the ABL70 with minimal instruction No special user skills or training are needed Portable with Battery Operation Weighing less than 15 pounds 6 kg and smaller than any benchtop analyzer the ABL70 can easily be brought to any Near Patient Testing setting with true flexibility of use The automatic battery operation enables patient samples to be run on the analyzer even during power disruptions or extended transport Easy Data Transfer and Storage The ABL70 has an integrated bar code reader for easy and secure transfer of patient ID user ID and accession numbers Patient data can be saved in the system s memory on a 3 5 diskette or sent via the serial port connector to the hospital s information system OPTR Enhanced Manager Control The ABL70 can be set up to lock out patient testing if QC fails or is not completed and password protection is also an option to prevent unauthorized use Strengths e Fast Blood Analysis Time is 60 S
116. provide a complete portfolio of products to meet the needs of our Hospital Point of Care customers The portability and simplicity of Roche OPTI R analyzers make them ideal for Hospital Point of Care solutions such as those arising in operating theatres intensive care units and emergency The reusable cassettes which can be used up to 25 times further simplify the measurement process as they do not need to be changed during critical situations e g operation Through the introduction of the Roche OPTI R system Roche is now able to fill the gap of the mid range sample throughput of 3 12 patient samples per day with a competitive parameter panel simple maintenance design and reasonable cost per test Upon reviewing the Launchbook if you have any additional questions regarding this product or information please contact us at your convenience For product related items please contact Global Systems Support in Atlanta headed by Ms Gerri Priest Tel 001 770 576 5000 616 Fax 001 770 576 5010 For marketing related items please contact Ms Ruth Draisbach Senior Marketing Manager Global Marketing Hospital Point of Care Tel 49 621 759 4581 Fax 49 621 759 9168 Mobile 49 175 723 4892 With best regards Your Roche OPTI R Team 2 2 1 The Time Saving Solution for Multiple Situations Roche OPTI R Critical Care Analyzer Offers time saving flexibility e g in the
117. put up to 10 samples per day The Roche OMNI products are targeted for Hospital Point of Care users with a high sample throughput of greater than 20 patient samples per day Currently Roche does not offer any HosPoC instruments for the mid range sample throughput With OPTI R Roche is now able to fill the gap of the mid range sample throughput of 3 12 patient samples per day with a competitive parameter panel simple maintenance design and reasonable cost per sample 5 3 Marketing the OPTI Analyzer Market Analysis 5 3 1 Market Potential A study conducted by the Wilkerson group estimates that POCT will account for 5196 of all critical care testing in 2005 see graph 3 below 10096 9096 8096 7096 60 so Jede 4096 3096 20 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 Adoption Graph 3 Market Development source Wilkerson group 1996 1998 The worldwide annual growth for the Hospital Point of Care systems is estimated as follows see graph 4 below Systems Annual 5 S Single 19 96 1000 800 600 400 200 use hendheld OPTI CCA Small decentral 17 96 benchtops OPTI R Omni Big decentral 4 96 benchtops Lab blood gas 3 96 Electrolytes only 96 Total 2 3 96 Graph 4 Market development Mio CHE source Business Plan Hospital Point of Care Blood Gas a
118. r label Shelf Life The stability of the cassette within the sealed pouch is six months from date of manufacture NOTE Please take into account the minimum shelf life when placing your orders 6 6 7 4 Syringe Adapters 125 pcs Roche Reference Number 03133559180 Use For use with Roche OPTI R cassettes when sampling from syringes Contents Each package contains an insert sheet and one hundred twenty five 125 adapters in a plastic bag 6 6 7 5 Syringe Adapters 30 pcs Roche Reference Number 03144267001 Use For use with Roche OPTI R cassettes when sampling from syringes Contents Each package contains an insert sheet and thirty 30 adapters in a convenient application tray 6 6 7 6 Roche OPTI check Quality Control Material Roche Reference Number 03113027180 Use For quality control measurement of pH PCO PO and SO with the OPTI R Critical Care Analyzer Contents Each tri level package contains 30 vials 10 1 7mL each of level 1 2 and 3 Package contains insert sheet with bar coded assay ranges for easy entry into the OPTI R Analyzer Composition Level 1 Respiratory acidosis as represented by pH and PCO values with low PO Low values of and SO High values of Ca and Vials identified by a red label Level 2 Normal values with moderately decreased SO Vials identified by a yellow label Level 3 Respiratory alk
119. raction failure safe sample measurement e Simple user interface e Low maintenance requirement Cassette storage esp since volume varies so much e Battery and mains operation portability e Easy data integration no user interaction Additional information No Additional Information Acquired Decision Drivers Ease of Use Low complexity Minimal Maintenance requirements Reliability Connectivity Additional OPTI R Features to Highlight Connectivity Options Makes downloading patient and QC samples simple so they remain in control no matter who performs the test Data Storage and Flexible Connectivity Automatic Aspiration of Sample Demonstrates overall ease of use and low training requirements especially important to POC coordinators who are responsible for training activities e Ease of Sampling Automatic aspiration of sample eliminates special techniques and back splatter potential from injection Minimizes training requirements Tas 5 10 6 Information Service IS Department Typical Audience Operators T specialist e Network Specialists e System Manager Interest Again the IT or IS department is a service unit for the hospital They have to ensure that data and information travels seamless through the hospital system and is made available where needed and in the format needed They have to integrate many diversified systems into one LIS HIS analyzers administration imaging
120. s likely to affect the optical signal measured by the OPTI R Analyzer or the optical properties of the sensor measured by the analyzer To cause interference to the optical sensors the substances must be highly mobile low molecular weight and highly colored in order to penetrate the optode membrane barriers quickly within the 90 sec measurement interval and then strongly absorb light or emit light of the proper color To cause 6 Wolfbeis OS Offenbacher Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and Actuators 9 p 85 1986 7 NCCLS Interference testing in clinical chemistry Proposed Guideline NCCLS Publication EP7 P Villanova PA NCCLS 1986 interference to the tHb and SO reflectance measurements the substances must strongly absorb or scatter red or infrared light relative to normal whole blood The following substances were tested in whole blood at the NCCLS recommended test level or higher and showed no interference to any measured analyte including blood gas electrolytes and tHb SO Bile Acids 30 umol dL Bilirubin 40 mg dL Beta Carotene 3 0 mg dL Hemolysis 10 During hemolysis is released from the blood cells thereby increasing the measured In the same manner protein released from the cells binds ionized Ca and decreases the concentration While an accurate value is reported it will reflect the actual changes caused by
121. spite of this an error cannot be corrected Roche Service has to be contacted 6 6 7 Consumables 6 6 7 1 Calibration Gas Roche Reference Number 031123731880 Use For calibration of pH in the Roche OPTI Critical Care analyzer Contents Each disposable low pressure cylinder contains approximately 2 liters of gas at less than 145 psi at 21 C Composition Oxygen 14 0 0 0296 Carbon Dioxide 6 0 0 02 Nitrogen balance Storage Refer to package labeling 6 6 7 2 OPTI R SnapPak Roche Reference Number 031123731880 Use For washing and calibrating cassette and waste containment for OPTI R Analyzer Contents 180mL of buffer solution Composition Aqueous HEPES bicarbonate buffer solution with biocides Storage Refer to package labeling 6 6 7 3 Cassette 25 Type Roche Reference Number 03133532180 Use For measurement of pH PCO tHb and SO with the OPTI Critical Care Analyzer Each cassette provides 25 patient samples or 5 day s of in use operation Contents Each package contains an insert sheet and four 4 cassettes Each plastic cassette contains buffer and optical sensors Composition Aqueous HEPES bicarbonate buffer solution 0 2mL with biocides Storage Refer to package labeling 4 C to 30 C 39 F to 86 F until expiry date Stability Expiration date and lot number are printed on each cassette containe
122. structure in which these can be served best because the right solution depend on several factors e g distances between ERs ICUs ORs and lab s test order pattern menue day night department methods for sample and information transfer Therefore the Hospital Point of Care Testing does not threaten the lab organizations On the contrary the POC Testing can be used to promote defend and expand the hospital lab s role What are the Critical Care Parameters Below is a list showing the 18 tests which are important to the management of patients on a critical care basis The analytes are listed in the order of importance listed by 54 participants of a focus panel consisting of nurses and physicians Tsas Arterial blood gases e Calcium e White blood count WBC Hemoglobin Hct e BUN e Magnesium Electrolytes Na e Creatinine e Activated clotting time ACT PT Complete blood count CBC e Cardiac Marker Troponin I T PTT e Platelets e Creatine kinase CK Glucose e Alcohol e Lactate 5 5 Consequence for the Roche Product Portfolio There is a need for a fast reliable relatively low price blood gas electrolyte analyzer that is easy to use and can be used on the spot without waiting for the result from the laboratory The Roche OPTI R Analyzer 5 6 SWOT Analysis Roche OPTI R Critical Care Analyzer 5 6 1 Strengths Innovative product features and reliable technology that pro
123. suring and is virtually maintenance free There are no preparations of e g measuring cassettes before a blood gas measurement can be initiated This means that an ABL77 is always ready for measuring so that the hospital staff saves time and at the same time the risk of pre analytical errors is minimized Small portable analyzers like the ABL77 are particularly in demand in the Point of Care segment which is the fastest growing segment in the blood gas market The Point of Care segment consists primarily of the hospital s patient wards where it is desirable to measure blood gases and other parameters close to the patients Thus the doctors will have the information they need in the treatment of critically ill patient more quickly Exactly because prompt measuring results are so important the fast ABL77 analyzer will have a considerable competitive advantage in this segment An Important Milestone after the Acquisition of SenDx Medical Inc The ABL77 is a further development of the analyzer generation which Rhe OPTR Radiometer took over when acquiring SenDx in 1998 The introduction of the ABL77 is an important milestone for Radiometer and SenDx Medical Inc because the analyzer is a result of the cooperation between the two organizations says Johan Schroder President amp CEO of Radiometer A S The new product includes Sensors and substrates that are the result of a joint development effort between Copenhagen and SenDx In that wa
124. tc ICUs are not the primary target market for GEM Premier and Radiometer ABL70 because both analyzers are not easy to transport they offer no battery GEM Premier or no adequate battery operation Radiometer ABL70 T E E Decision Drivers e Fase of Use e Logistics Storage e Data Transmission into HIS LIS e Quick Turn Around Time Additional OPTI R Features to Highlight e Ease of Sampling Automatic aspiration of sample eliminates special techniques and back splatter potential from injection Minimizes training requirements e Automatic Calibration and Barcode Capability No need to manually enter cal data or patient data e Room Temperature Storage Eliminates having to manually record new out of refrigerator expiration date Waiting for cassettes to equilibrate etc Won t bea big issue unless they have been exposed to I Stat Data Storage and Flexible Connectivity Ensures regulatory compliance with easy transmission of data Infrared will be big issues because they are used to hard wiring 5 10 3 Cardiac Catheterization Lab Angioplasty Opening obstructed arteries Stents used to prop arteries open Cardiac Catheterization Diagnostic test dye is injected into coronary artery with Xrays Typical Audience Operators e Medical Director e Nurse Manager Clinical Interest No Additional Information Acquired Main Parameters Needed No Additional Information Acquired Critical issues for t
125. tilator and or infusions Main Parameters Needed PO2 tHb SO to determine tissue oxygenation oxygen transport function tHb indicator for blood loss internal bleeding after surgery pH 2 to determine the acid base balance e g respiration water balance kidney renal function nerve and muscle function Glucose monitoring of diabetes patients as well as in patients with liver or pancreas problems Critical issues for the user Turn around time ease of use reduced training requirement accuracy and precision of results to base decisions on calculated parameters RT low maintenance of the equipment clot removal QC issues perceived as additional paperwork portability size logistics cassette availability cost considerations compared to bench top analyzers as alternative Less Critical Sample volume Typical sample throughput 10 100 per day depending on number of ICU beds Important OPTI R features to highlight Uniform sample aspiration reduces user training requirements Aspiration from most types syringes Convenient cassette storage at Room Temperature for up to 6 months from date of manufacture e Minimum maintenance requirements Data management system integration Additional information Nurses like easy and fast access to the results required by the physician TAT to start there action asap They don t like to be involved in technical issues maintenance QC clot removal e
126. tion Calcium in open heart is the main controlling ion for contraction of the myocardium heart muscle it also plays a role in blood coagulation Critical issues for the user Sampling ease of use aspiration vs injection Turn Around Time analysis time measurement analysis cassette logistics instrument and analysis reliability maintenance size battery operation Less Critical Sample volume Data management Typical sample throughput 1 30 per day depending on type of operating room OR and type of surgeries cardiac has more than general surgery Important OPTI R features to highlight Uniform sample aspiration reduces user training requirements tHb measurement SO measurement Ease of use Low complexity Battery mains operation Convenient cassette storage at room temperature RT for 6 months Minimum maintenance requirements Tas Additional information Anesthesiologists are technically oriented people they do not shy away from analyzer operation If Analyzer is used in the individual OR the Anesthesiologist looks for analyzers which do not need attention they want to keep their eyes on the control board If used outside the operation room it is most likely operated by an OR nurse Here ease of operation low maintenance is key Decision Drivers Speed to result Ease of Use Including QC Menu yData Connectivity Additional OPTI R Features to Highlight
127. to increased plasma bicarbonate or a feature of respiratory alkalosis due to an increased elimination of due to hyperventilation T ss decreased pH value acidemia in blood serum plasma may occur due to an increased formation of organic acids an increased excretion of H ions in certain renal disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or maybe be chronic as the result of obstructive or restrictive respiratory diseases Reference Interval pH Laboratory normal ranges for arterial carbon dioxide tension are well documented and widely accepted Parameter Mean 2SD pH 7 40 7 35 7 45 3 2 2 The value of arterial blood is used to assess how well the body eliminates carbon dioxide a by product of metabolism A PCO value below the normal range is termed respiratory alkalosis and indicates hypocapnia a condition caused by increased alveolar ventilation such as hyperventilation An arterial PCO above the normal range is termed respiratory acidosis and indicates hypercapnia a sign of ventilatory hypoventilation and failure resulting from cardiac arrest chronic obstructive lung disease drug overdose or chronic metabolic acid base disturbances Reference Interval PCO Labor
128. u uipg urqi Hd peyipour o uoosa1on 4 oujeuronuojoq PUNUA Od o uoosa1on 4 cOOd 598 x 000 S YId VINNI Supe LVLS VOO Trud TI W9 TI 21njeoq 4 99304 D 0002 SN Id PIU 0006 y 4 8 2 V N skeq c 35 BI A Ayoede OO SE 8 V N V N uned cc 95 01 4 osn u VIN skep IZ skep pI SYPOM p Wd 0 BIRIAL 006 10 OST 006 20 OST 041 06 FpD s N BuUIS 8 ISN 07 ooue12opoi QIW WLP V N VIN qpi2uspaeA npnj 8012 225 10811 VIN V N _ 10811 205 IN ISN QW PULAI D n A PWP VIN VIN Surge s 14871 VIN VIN 8 598 0006 51114 VINI Supe LVIS VOO WD TI uro T 21njeoq 082 0002 99304 7 2 2 Instrumentation Laboratories http www ilww com Corporate information collected via the internet and or other Instrumentation Laboratories sources and is subject to ch
129. unstable unstable 25 mg dL Rapidly sedimenting blood samples should be mixed thoroughly and immediately aspirated into the OPTI R cassette as described above in Handling and Storage of Samples to ensure accurate tHb measurements If allowed to sediment the blood sample s reported tHb may be falsely high or low Only clear uncolored quality control materials such as Roche OPTI check brand aqueous controls should be used with the OPTI R system Colored materials including proficiency testing materials may interfere with the pH or ion measurement or fail to be properly aspirated The OPTI R system was evaluated for the interference of sample temperature on measurement iced samples No measurable sensitivity to sample temperature was found 3 5 Sample Material 3 5 1 Sample Requirements Blood sampling for analysis must be performed under proper medical supervision with details of collection including sampling devices site selection sample handling documentation and specific procedures used approved by the personnel responsible 3 5 2 Anticoagulants and Sample Collection Devices Lithium heparin is the only acceptable anticoagulant for blood gas and electrolyte analysis Lithium heparin sodium heparin or balanced heparin salts are the only acceptable anticoagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and shou
130. ve tHb offset of up to 3 g dL typically within the range 7 12 g dL Measuring Range pH 6 6to 7 8 pH units 2 10to200 mmHg 2 10 10700 mmHg 100 10 180 mmol L K 0 8to 10 mmol L Ca 0203 0 mmol L tHb 5 to 25 g dL SO 60to 100 Any measurement outside the Displayable Ranges will be indicated on the display as LOW for values lower than the range and HIGH for values above the range However the printed report will show out of range values with reference to the end value of the measurement range for example the printed report will show a PCO value of 220 mmHg as gt 200 mmHg Meas Lim 4 Mahoney JJ Wong RJ Van Kessel AL Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 79 1993 5 J B Henry Clinical Diagnosis and Management by Laboratory Methods 19th Ed 1996 p 590 777 SSCS A 3 4 Interferences Optode pH measurements have a known sensitivity to the blood ionic strengthPj which is determined primarily by variation in serum levels of sodium The OPTI R Analyzer utilizes an internal sensor to actively compensate and correct for this sensitivity That is the OPTI R Analyzer s reported pH has no measurable interference from hyponatremic or hypernatremic samples nor for ionic strength variations within the physiologic limits of 100 to190 mmol L The OPTI sensor has no measurable interference from
131. vice concept For further detailed information please contact the responsible Global System Support in Graz or Roswell 9 1 1 General The customer should be able to solve the following problems with assistance by phone Recognize operator errors Eliminate contamination cleaning of the instrument Check of the instrument performance by using controls Report cause of error to service team by phone or letter 9 1 2 Instrument Repair Prior to returning the OPTI R Analyzer for repair the instrument functionality should be assessed utilizing the onboard diagnostic routines Additionally when possible three levels of OPTI check liquid quality control material should be run For further information an error log may also be printed to provide assistance in troubleshooting the analyzer prior to shipment back to the site of manufacturing Just in case that OPTI R Analyzer can t be repaired locally please send the defective OPTI R instruments to the respective repair centre in Graz or Roswell by using the RA procedure Please answer all the questions on the RA form with the greatest care and sign the form Country code Problem date Type of instrument Serial number of instrument Installation date of instrument Defective instrument or spare part Part number and material number of the spare part Old new serial number Fault description etc All returned instruments parts should be individually labeled w
132. vide accuracy ease of use minimum maintenance and cost efficiency Small and portable instrument for decentralized use Rapid time to result Approximately one 1 minute Easy handling does not require high skill or special training Flexibility with modular or cassette systems to accommodate both centralized or decentralized BG testing requirements Seamless integration of patient and quality control results directly into the facilities LIS HIS with DataCare OMNILink e Roche broad Hospital Point of Care portfolio e Strong Roche market presence in the blood gas electrolyte testing market 5 6 2 Weaknesses Lack of proof sources that support the BG analyzers and document the positive experience in prominent accounts OPTI R Menu limitation for the ER ICU and CCU missing creatinine lactate and coag Sample volume too large for neonatal samples NICU 5 6 3 Opportunities Use the power of the combination of the total Roche Hospital Point of Care product portfolio Gain access to key decision makers through Laboratory Systems and Diabetes Care account relationships in large hospitals identify timing for replacement analyzers and potential for decentralized testing sites Leverage benefits of Data Management connectivity and data management for competitive replacements OPTI sales in the OR through targeting of profusionists with the value of measured hemoglobin versus conductive hematocrit USA only 5 6
133. y we have really managed to utilize the synergistic effects of bringing the two companies together The ABL77 is based on a thick film sensor technology and it measures pH blood gases three electrolytes and the hematocrit values on just 85 microliter blood This is less than half the amount of blood used by the previous generation and it makes the ABL77 well suited for neonatal and pediatric departments The sensor cassette can be stored at room temperature and is sold in several configurations with different parameters and test volumes The ABL77 is operated via a large color screen and the use of large icons makes the software very intuitive even for the less experienced user The operating system is Windows CE and the software can very easily be configured according to the customer s needs In addition the ABL77 can easily be connected to the hospital s information systems With the introduction of the ABL77 Radiometer has further strengthened its product line which thus continues to be the most up to date and competitive total solution in the blood gas measurement market OPTR 8 Evaluation Results 8 1 Field Test Results 8 1 1 Objective The objective of these studies was to validate the performance of the Roche OPTI R Analyzer during normal operation operated by minimally trained personnel 8 1 2 Field Test Sites These field test sites include both correlation to predicate devices and 20 day precision studies
134. ystem incorporates everything needed to perform blood analysis at the patient bedside Single use disposable test cartridges and a micro processor controlled handheld analyzer allow true mobility to all areas of the hospital where the immediacy of test results is clinically valuable Portable printers and infrared communication interfaces allow all patient information obtained at the bedside to be printed on demand and uploaded to the hospitals centralized information systems for record keeping and billing In late 1994 i STAT Corporation expanded its technology in portable blood analysis by developing a blood gas test panel pH PCO2 amp PO2 to complement its existing test menu of electrolytes and blood chemistries An enhanced version of i STAT s Portable Clinical Analyzer was introduced to provide thermal control for those tests that require measurement at 37 C Entry of demographic information was expanded beyond patient and user identification numbers to include patient temperature sample type arterial Rhe OPTR venous capillary FIO2 and three user definable fields for data such as ventilator settings The addition of blood gas testing to the i STAT System enables members of the medical staff to quickly assess metabolic conditions monitor mechanical ventilation oxygen therapy or medications and immediately react to complications without leaving the patient s side A broad range of laboratory tests are available in a variety of

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