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The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order: pH, pO2, and pCO2 : pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium (cK'): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa"): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The following six parameters will be introduced with the ABL80 FLEX CO-OX: Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. sOx oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. FO₂Hb: oxyhemoglobin as a fraction of total hemoglobin. FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: methemoglobin as a fraction of total hemoglobin. FHHb: reduced hemoglobin as a fraction of total hemoglobin.

The ABL80 FLEX CO-OX syste:n consists òf a modular analy.cer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidis modules. The user interface module contains the analyzer CP1J and all of the required electronic interfaces for external communication and data stor:ge. Sensors that measure pH, pCO2, pO2, cCa2', cCI, cK* cNa* and cGlu are contained in a cassette that also contains the sample inlet. This cassette attaches to the front of the analyzer. The oximetry module measures ctHb, sO2, FO2Hb, F MetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the analyzer. The system also includes a reagent cartridge for the calibration and automatic quality control of the sensor and oximetry system. The calibration and quality control reagents are packaged in sealed foil pouches. The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration and quality control data.

The ABL 80 FLEX is a portable, automated system that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of- care setting. These tests are only performed under a physicians order: pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement. pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs. pCO2: pCO2is a direct reflection of the adequacy of alveclar ventilation in relation to the metabolic rate. Potassium (cK*): The potassium level is the predominant intracellular cation. It is fundamental for correct neuromuscular activity Sodium (cNa"): The sodium ion is the most abundant cation in plasma. It is the foremost agent involved in maintenance of osmolality and body fluid volumes. Calcium (cCa2): The calcium ion is the most abundant mineral element in the human body and is involved in numerous enzymatic processes, blood coagulation, cell growth, and membrane transport mechanisms as well as plays an important role in nervous impulse conduction, neuromuscular transmission, and muscular contraction and relaxation. Chloride (cCl): The chloride ion is the main extracellular anion and plays an important role in maintaining electrical neutrality. Hematocrit (Hct): The hematocrit measurement is the ratio of the volume of red blood cells in whole blood in comparison to the total volume. Glucose (cGlu): The glucose measurements are used to screen for, diagnose and monitor glycemic levels in potential pre-diabetic, diabetic, hypoglycemic patients.

The ABL80 FLEX System consists of a modular analyzer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage. The system also includes a reagent cartridge for the calibration and automatic quality control of the analyzer and sensor system. The calibration and quality control reagents are packaged in sealed foil pouches, similar to the existing ABL 77 cal pack. The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration data.

The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.

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The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.

The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and a calibration solution pack. A bar code label containing lot and sensor-specific identifying parameters accompanies each new sensor cassette and calibration solution pack. The SenDx 100™ line is available in two versions: Model SD 100 B with modem Model SD 100 IB without modem for international use The SD100B is sold in the United States and is UL certified. The unit is battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Jerome Industries power supply model WSZ118M which requires 100 to 250 VAC, 50 to 60 Hertz with these units. It also has a modem. The SD1001B is sold internationally and is certified by TUV Rheinland. This unit is also battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Advance Power Solutions power supply model AD-740U-1180 which requires 100 to 240 VAC, 50 to 60 Hertz with these units. This model is not equipped with a modem. The SenDx 100™ analyzer utilizes microprocessor controlled electronics. The microprocessor controls the touch screen display, the analog electronics for processing sensor output, and the integral thermal printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced into the analyzer via an aspiration stylus. The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (pO2), carbon dioxide (pCO2), pHx, sodium (Na+), potassium (K+), chloride (Cl-), ionized calcium (iCa++), and hematocrit (Hct) in a multi-use, disposable cassette assembly. The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for pO2 measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO2, Na+, K+, Cl- and iCa++ have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity. The sensors are contained in a low volume flow-through cell. The sensor cassette contains reference electrodes for the potentiometric sensors and an integral temperature sensor and heating element for precise temperature control. Calibration and analysis are carried out at 37.0°C. The SenDx 100™ analyzer allows for patient temperature correction over the range of 12-45°C. All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions. Calibration of the system is accomplished using a calibration solution pack which contains two levels of precision tonometered electrolyte solutions packaged in gas tight disposable cartridges. Precise pH, blood gas, and electrolyte calibration values for each pack are provided on an attached calibration bar code label. The SenDx 100TM performs two point calibrations at automatic intervals. Throughout the calibration and sample analysis phases, sensor signals are continuously monitored. If any abnormal conditions are detected, an error message is generated. Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na+, K+, Cl-, iCa++, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO3-, BEb, BEecf, TCO3, SBC, Hb, and %O2 Sat) are automatically printed. The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.