noninvasive revolutionary Blood Cell Storage Inc. North Canal Office Park 146 North Canal Street Suite No. 330 Seattle, WA 98103, USA Tel.: 206-632-7314 Fax: 206-632-7349 info@bloodcellstorage.com www.bloodcellstorage.com noninvasive “...it’s in the bag” “...it’s in the bag”™ revolutionary Publications and Presentations Platelet Concentrates in pH Reading Containers M. Dijkstra-Tiekstra, J. de Wildt-Eggen, L. Scholten-Pijper, A. Setroikromo, C. van Delden Time Course of pH in Platelet Concentrates after Bacterial Contamination T. Montag, S.-B. Nicol, U. Schurig, J Brachert, A. Sauer, T, Müller, C.K. Schneider Paul-Ehrlich Institut, Mikrobielle Sicherheit, D Langen, German Red Cross-Blood Transfusion Service NSTOP, D Institute Springe Non-Invasive Measurement of Platelet Concentrate pH with Fiber Optic Fluorescence Detector: D. de Korte, R. Vlaar, Eric C.W.N Gouwerok, I. De Cuyper, E. Jan Klip, A. Verhoeven, Sanquin Research at CLB, Amsterdam, Netherlands; M. Reed, S. Geelhood, BCSI Seattle, WA USA Daily Non-Invasive Fluorescence Ratio Measurement of Platelet Concentrate pH Can Detect the Presence of Bacteria: L. Barker, O. Nanassy, M. Reed, S. Geelhood, R. Pfalzgraf, BCSI Seattle, WA; G. Cangelosi, Seattle Biomedical Research Institute, Seattle, WA. (AABB 2006 SP49) Non-Invasive Measurement of Platelet Concentrate pH with a Fiber Optic Fluorescence Detector: M.W. Reed, S.J. Geelhood, BCSI, Seattle, WA USA; A.J. Verhoeven, D. de Korte, Sanquin Research at CLB, Amsterdam, Netherlands Effect of Extracellular pH on Platelet Concentrate: D. de Korte, D.W.C. Dekkers, I.M. De Cuyper, R. Verhaar, P. van der Meer, and A.J. Verhoeven; Sanquin Research at CLB, Amsterdam, Netherlands The Efficacy and Platelet Biocompatibility of a Non-invasive Fluorescent pH Detector, S.J. Geelhood1, M.W. Reed1, T.A. Horbett2, 1 Blood Cell Storage, Inc. Seattle, WA, 2University of Washington, Seattle, WA BCSI pH1000 Specifications Dimensions LxWxH 36 cm x 39.7 cm x 11.4 cm (14.2 in x 15.6 in x 4.5 in) Weight 2.35 kg (5.2 lbs) External Connections • PS2 for Barcode Reader • RS-232 DB-9 (male), for serial communication • Ethernet Power Requirements (AC Power Adapter) Input power to power adapter: • 100 - 240 VAC, 50 to 60 Hz, 0.6 A max, 15 W max • Main supply voltage fluctuations must not exceed ± 10% of nominal value. • Transient over voltages typically present on the main supply is expected to be impulse withstand (over voltage) category II of IEC 60364-4-43. Adapter output power: 9VDC, 1.7A max. (Note: Input connectors are available for; Continental Europe, the United Kingdom, North America and Australia.) Operating Temperature Range 5 - 40°C (41 - 104°F) Operating Humidity Range 5 - 80% relative humidity, non-condensing Operating Altitude Maximum altitude 2000 m (6562 ft.) Pollution Degree Classification Pollution Degree 2 Operating Environment The instrument is intended for indoor use only. Transport and Storage Conditions Temperature: -10 - 50°C (14 - 122°F) Humidity: 5 - 98% relative humidity, non-condensing Atmospheric pressure: 50 kPa - 106 kPa (0.5 atm - 1 atm) Keypad 10 character alphanumeric keys 2 special function keys Display 2 line by 20 character Liquid Crystal Display (LCD) BCSI pH1000 ™ World’s first noninvasive Platelet Concentrate pH Detector. BCSI pH1000 Platelet Storage Bag Specifications NOT FOR SALE IN THE U.S. Volume: 1300 ml total for a nominal 300 ml of platelet concentrate Sample Ports: 2 twist off sample ports Fluid Path: Sealed, sterile, pyrogen free & excellent biocompatibility Material: PVC/citrate — Soft flexible film with high transparency pH Reading: Fast and accurate reading from pH 6.2 to 7.8 (reported at 22°C) Blood Cell Storage Inc. © BCSI 2007 10/07 CE MARK 0344 NOT FOR SALE IN THE U.S. CE MARK 0344 • pH is an indicator of platelet quality The BCSI pH1000: Platelet Concentrate pH Detector System • Low or rapidly declining pH may identify units with: BCSI developed a novel and proprietary system that provides a method for – Transportation damage noninvasively monitoring the health of platelets inside the bag. BCSI’s optical – Poor storage characteristics sensing technology is incorporated directly into a platelet storage bag, allowing – Bacterial contamination multiple measurements with no sampling. The BCSI pH1000 detection system • Most countries require pH measurement consists of a fluorometer that measures light emissions and a biochemical sensor Why Use a Non-Invasive System? located in an insert incorporated into one of the platelet bag’s ports (“...it’s in the • Eliminates the risk of contaminating platelet units during pH testing and intensity as proprietary biochemicals in the insert sense pH changes inside the • Eliminates loss of platelets due to quality control bag. The fluorometer measures the fluorescent light intensity of the biochemical • Rapid, easy-to-use, non-invasive system allows every bag to be measured sensor. The reading is not affected by different colors of plasma, including those • pH1000™ reduces the likelihood of user error from women on contraceptives, those containing excessive fat, and those with high Why Measure pH of Stored Platelets? bag”). When the sensor is illuminated, it emits a glow. This glow changes color red blood cell counts. The optical sensing technology allows noninvasive pH monitoring of the health of platelets, it allows for multiple readings over days of storage while maintaining the sterility within the bag. BCSI pH1000: pH Measured Over Time BCSI pH1000 tracks pH accurately over days 7 .5 BCSI pH 7 .4 Four sterile BCSI platelet storage bags with pH reading inserts were equipped with septum adaptors to allow daily (invasive) reading with a Bayer Rapidlab blood gas analyzer. Noninvasive BCSI pH readings were consistent with the blood gas readings. The mean difference from average pH determined by both methods was 0.045 (n=32, SD 0.058). Blood Gas pH 7 .3 BCSI pH Detector “...it’s in the bag” Fast – takes only seconds per measurement, including self-calibration User Friendly – easy to use NonInvasive – eliminates risk of contamination REVOLUTIONARY – take multiple readings up to time of transfusion ECONOMICAL – allows optimal use of scarce resources Space Efficient – only 36 cm x 39.7 cm (14.2 in x 15.6 in) pH AT 37°C 7 .2 7 .1 7 6 .9 6 .8 6 .7 6 .6 6 .5 0 1 2 3 4 5 6 7 STORAGE TIME, DAYS 8 9 10 11