INTERMITTENT CARTRIDGE. The Cartridges are compatible with the XXXX SL Blood Analysis System & a subset are also compatible with the Portal Product. Cartridge Specifications (XXXX & Portal): Category Specification -------------------------------------------------------------------------------- Operating Temperature: 12-30C (54-86F) Cartridge Storage Temperature: 15-30C (59-86F) Measurement Temperature: 37C ---------- /2/ Carmeda, Bioactive Surface - Heparin Operating Relative Humidity: 0-80% Operating Barometric Pressure: 350-900 mmHg (measured by on-board barometer) Sample Size: 0.125-5.0 mL Analysis Time: Less than 90 seconds after sample injection (depends on parameter) Size (LxWxH) and Weight: Cartridge Temp Card: 2.6" x 1.3" x 0.6; 1oz. 66 x 33 x 15.24mm; 28g. Cartridge/Analyte Configurations: Cartridges are available in the following configurations: -------------------------------------------------------------------------------- Cartridge Measured Calculated ================================================================================ 11. BG pH, pCO//2//, pO//2// HCO//3///-/, TCO//2//, Beb, BEecf, O//2//Sat -------------------------------------------------------------------------------- CC pH, pCO//2//, pO//2//, HCT, HCO//3///-/, TCO//2//, Beb, Na/+/, K/+/, iCa BEecf, O//2//Sat, tHb, iCa(N) -------------------------------------------------------------------------------- H3 HCT, Na/+/, K/+/, iCa tHb, iCa(N) -------------------------------------------------------------------------------- H4 HCT, Na/+/, K/+/, Cl/-/, tHb BUN/Urea -------------------------------------------------------------------------------- GL/3/ Glu, Na/+/, K/+/, Cl/-/ -------------------------------------------------------------------------------- Cartridge Equilibration Times: Following removal from their shiping container, XXXX cartridges must equilibrate to room temperature prior to use. Equilibration time depends on the product type as follows: --------------------------------------- Cartridge Equilibration Time (hours) ======================================= BG 72 --------------------------------------- CC 72 --------------------------------------- H3 1 --------------------------------------- H4 1 --------------------------------------- GL/1/ 1 --------------------------------------- ---------- /3/ Available only on XXXX Reportable Ranges : The default reportable ranges for each parameter are as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- pH 6.000 - 8.000 pH units ------------------------------------------------------------------- pCO//2// 4.0 - 200.0 mmHg (0.53 - 26.6 kPa) ------------------------------------------------------------------- pO//2// 20.0 - 700.0 mmHg (2.67 - 93.33 kPa) ------------------------------------------------------------------- Hct 10.0 - 80.0 % (.100 -.800 SI) ------------------------------------------------------------------- Na/+/ 80.0 - 200.0 (mM, mEq/L) ------------------------------------------------------------------- K/+/ 1.00 - 20.0 (mM, mEq/L) ------------------------------------------------------------------- iCa 0.20 - 5.00 mM (0.80 - 20.4 mg/dL; 0.40 - 10.00 mEq/L) ------------------------------------------------------------------- Cl/-/ 30.0 - 150.0 (mM, mEq/L) ------------------------------------------------------------------- BUN/urea (H4 P/N 055700) ------------------------------------------------------------------- BUN 3 - 100 mg/dL (1.1 - 3.57 mM) ------------------------------------------------------------------- Urea 6 - 321 mg/dL (1.1 - 35.6 mM) ------------------------------------------------------------------- BUN/urea (H4 P/N 055703) ------------------------------------------------------------------- BUN 3 - 150 mg/dL (1.1 - 53.5 mM) ------------------------------------------------------------------- Urea 6 - 321 mg/dL (1.1 - 53.4 mM) ------------------------------------------------------------------- Glu/1/ 20 - 500 mg/dL (1.1 - 27.8) ------------------------------------------------------------------- Calculated ------------------------------------------------------------------- HCO//3///-/ 0 - 99.9 mM ------------------------------------------------------------------- TCO//2// 0 - 99.9 mM ------------------------------------------------------------------- Beb +/- 99.9 mM ------------------------------------------------------------------- Beecf +/- 99.9 mM ------------------------------------------------------------------- O//2//Sat 0 - 100% ------------------------------------------------------------------- tHb 3.4 - 27.2 g/dL (2.1 - 16.9 mM) ------------------------------------------------------------------- iCa(N) 0.20 - 5.00 mM (0.80 - 20.04 mg/dL; 0.40 - 10.00 mEq/L ------------------------------------------------------------------- Display Resolution: The display resolution for each parameter is as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- pH 0.001 pH units ------------------------------------------------------------------- pCO//2// 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- pO//2// 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- Hct 0.1% (.001 SI) ------------------------------------------------------------------- Na/+/ 0.1 (mM, mEq/L) ------------------------------------------------------------------- K/+/ 0.01 (mM, mEq/L) ------------------------------------------------------------------- iCa 0.01 (mM, mEq/L, mg/dL) ------------------------------------------------------------------- Cl/-/ 0.1 (mM, mEq/L) ------------------------------------------------------------------- BUN/Urea 1 mg/dL (0.1 mM) ------------------------------------------------------------------- Glu 1 mg/dL (0.1 mM) ------------------------------------------------------------------- ---------- /1/ Available only on XXXX
Appears in 2 contracts
Samples: Manufacturing and Distribution Agreement (Diametrics Medical Inc), Manufacturing and Distribution Agreement (Diametrics Medical Inc)
INTERMITTENT CARTRIDGE. The Cartridges are compatible with the XXXX IRMA SL Blood Analysis Axxxxsis System & a subset are also compatible with the Portal Product. Cartridge Specifications CARTRIDGE SPECIFICATIONS (XXXX IRMA & PortalPORTAL): Category Specification XXTEGORY SPECIFICATION -------------------------------------------------------------------------------- Operating TemperatureOPERATING TEMPERATURE: 12-30C (54-86F) Cartridge Storage TemperatureCARTRIDGE STORAGE TEMPERATURE: 15-30C (59-86F) Measurement TemperatureMEASUREMENT TEMPERATURE: 37C ---------- /2/ -------------------- [2] Carmeda, Bioactive Surface - Heparin Operating Relative HumidityOPERATING RELATIVE HUMIDITY: 0-80% Operating Barometric PressureOPERATING BAROMETRIC PRESSURE: 350-900 mmHg (measured by on-board barometer) Sample SizeSAMPLE SIZE: 0.125-5.0 mL Analysis TimeANALYSIS TIME: Less than 90 seconds after sample injection (depends on parameter) Size SIZE (LxWxHLXWXH) and WeightAND WEIGHT: Cartridge Temp Card: 2.6" x 1.3" x 0.6; 1oz. 66 x 33 x 15.24mm; 28g. CartridgeCARTRIDGE/Analyte ConfigurationsANALYTE CONFIGURATIONS: Cartridges are available in the following configurations: -------------------------------------------------------------------------------- Cartridge Measured Calculated -------------------- ------------------------------------------- ----------------------------------- CARTRIDGE MEASURED CALCULATED ====================================== =========================================== 11. =================================== BG pH, pCO//2//pCO2, pO//2// HCO//3///-/pO2 XXX0-, TCO//2//XXX0, Xxx, BEecf, O2Sat -------------------- ------------------------------------------- ----------------------------------- CC xX, xXX0, xX0, XXX, Xx+, X+, xXx XXX0-, TCO2, Beb, BEecf, O//2//Sat -------------------------------------------------------------------------------- CC pH, pCO//2//, pO//2//, HCT, HCO//3///-/, TCO//2//, Beb, Na/+/, K/+/, iCa BEecf, O//2//SatO2Sat, tHb, iCa(N) -------------------------------------------------------------------------------- -------------------- ------------------------------------------- ----------------------------------- H3 HCT, Na/+/Na+, K/+/K+, iCa tHb, iCa(N) -------------------------------------------------------------------------------- -------------------- ------------------------------------------- ----------------------------------- H4 HCTXXX, Na/+/Xx+, K/+/X+, Cl/-/Xx-, XXX/Xxxx tHb BUN/Urea -------------------------------------------------------------------------------- GL/3/ -------------------- ------------------------------------------- ----------------------------------- GL[3] Glu, Na/+/Na+, K/+/K+ , Cl/-/ -------------------------------------------------------------------------------- Cartridge Equilibration TimesCl- -------------------- ------------------------------------------- ----------------------------------- CARTRIDGE EQUILIBRATION TIMES: Following removal from their shiping container, XXXX IRMA cartridges must xxxt equilibrate to room temperature prior to use. Equilibration time depends on the product type as follows: --------------------------------------- Cartridge Equilibration Time --------------------- ------------------------------------- CARTRIDGE EQUILIBRATION TIME (hoursHOURS) ===================== ===================================== BG 72 --------------------------------------- --------------------- ------------------------------------- CC 72 --------------------------------------- --------------------- ------------------------------------- H3 1 --------------------------------------- --------------------- ------------------------------------- H4 1 --------------------------------------- GL/1/ --------------------- ------------------------------------- GL1 1 --------------------------------------- ---------- /3/ --------------------- ------------------------------------- --------------------- [3] Available only on XXXX Reportable Ranges IRMA REPORTABXX XANGES : The default reportable ranges for each parameter are as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- -------------------------------------------------------------------------------- MEASURED -------------------------------------------------------------------------------- pH 6.000 - 8.000 pH units ------------------------------------------------------------------- pCO//2// ------------------- ------------------------------------------------------------ pCO2 4.0 - 200.0 mmHg (0.53 - 26.6 kPa) ------------------------------------------------------------------- pO//2// ------------------- ------------------------------------------------------------ pO2 20.0 - 700.0 mmHg (2.67 - 93.33 kPa) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Hct 10.0 - 80.0 % (.100 -.800 SI) ------------------------------------------------------------------- Na/+/ ------------------- ------------------------------------------------------------ Na+ 80.0 - 200.0 (mM, mEq/L) ------------------------------------------------------------------- K/+/ ------------------- ------------------------------------------------------------ K+ 1.00 - 20.0 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa 0.20 - 5.00 mM (0.80 - 20.4 mg/dL; 0.40 - 10.00 mEq/L) ------------------------------------------------------------------- Cl/-/ ------------------- ------------------------------------------------------------ Cl- 30.0 - 150.0 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/urea (H4 P/N 055700) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN 3 - 100 mg/dL (1.1 - 3.57 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Urea 6 - 321 mg/dL (1.1 - 35.6 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/urea (H4 P/N 055703) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN 3 - 150 mg/dL (1.1 - 53.5 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Urea 6 - 321 mg/dL (1.1 - 53.4 mM) ------------------------------------------------------------------- Glu/1/ ------------------- ------------------------------------------------------------ Glu[1] 20 - 500 mg/dL (1.1 - 27.8) ------------------------------------------------------------------- Calculated ------------------------------------------------------------------- HCO//3///-/ -------------------------------------------------------------------------------- CALCULATED -------------------------------------------------------------------------------- HCO3- 0 - 99.9 mM ------------------------------------------------------------------- TCO//2// ------------------- ------------------------------------------------------------ TCO2 0 - 99.9 mM ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Beb +/- 99.9 mM ------------------------------------------------------------------- Beecf ------------------- ------------------------------------------------------------ BEecf +/- 99.9 mM ------------------------------------------------------------------- O//2//Sat ------------------- ------------------------------------------------------------ O2Sat 0 - 100% ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ tHb 3.4 - 27.2 g/dL (2.1 - 16.9 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa(N) 0.20 - 5.00 mM (0.80 - 20.04 mg/dL; 0.40 - 10.00 mEq/L ------------------------------------------------------------------- Display Resolution------------------- ------------------------------------------------------------ DISPLAY RESOLUTION: The display resolution for each parameter is as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- -------------------------------------------------------------------------------- MEASURED -------------------------------------------------------------------------------- pH 0.001 pH units ------------------------------------------------------------------- pCO//2// ------------------- ------------------------------------------------------------ pCO2 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- pO//2// ------------------- ------------------------------------------------------------ pO2 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Hct 0.1% (.001 SI) ------------------------------------------------------------------- Na/+/ ------------------- ------------------------------------------------------------ Na+ 0.1 (mM, mEq/L) ------------------------------------------------------------------- K/+/ ------------------- ------------------------------------------------------------ K+ 0.01 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa 0.01 (mM, mEq/L, mg/dL) ------------------------------------------------------------------- Cl/-/ ------------------- ------------------------------------------------------------ Cl- 0.1 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/Urea 1 mg/dL (0.1 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Glu 1 mg/dL (0.1 mM) ------------------------------------------------------------------- ---------- /1/ ------------------- ------------------------------------------------------------ --------------------- [1] Available only on XXXXIRMA EXHIBIT 2.1 PRODUCT PRICES
Appears in 1 contract
Samples: Manufacturing and Distribution Agreement (Koninklijke Philips Electronics Nv)
INTERMITTENT CARTRIDGE. The Cartridges are compatible with the XXXX SL Blood Analysis System & a subset are also compatible with the Portal Product. Cartridge Specifications CARTRIDGE SPECIFICATIONS (XXXX & PortalPORTAL): Category Specification CATEGORY SPECIFICATION -------------------------------------------------------------------------------- Operating TemperatureOPERATING TEMPERATURE: 12-30C (54-86F) Cartridge Storage TemperatureCARTRIDGE STORAGE TEMPERATURE: 15-30C (59-86F) Measurement TemperatureMEASUREMENT TEMPERATURE: 37C ---------- /2/ -------------------- [2] Carmeda, Bioactive Surface - Heparin Operating Relative HumidityOPERATING RELATIVE HUMIDITY: 0-80% Operating Barometric PressureOPERATING BAROMETRIC PRESSURE: 350-900 mmHg (measured by on-board barometer) Sample SizeSAMPLE SIZE: 0.125-5.0 mL Analysis TimeANALYSIS TIME: Less than 90 seconds after sample injection (depends on parameter) Size SIZE (LxWxHLXWXH) and WeightAND WEIGHT: Cartridge Temp Card: 2.6" x 1.3" x 0.6; 1oz. 66 x 33 x 15.24mm; 28g. CartridgeCARTRIDGE/Analyte ConfigurationsANALYTE CONFIGURATIONS: Cartridges are available in the following configurations: -------------------------------------------------------------------------------- Cartridge Measured Calculated -------------------- ------------------------------------------- ----------------------------------- CARTRIDGE MEASURED CALCULATED ====================================== =========================================== 11. =================================== BG pHxX, pCO//2//xXX0, pO//2// HCO//3///-/xX0 XXX0-, TCO//2//TCO2, Beb, BEecf, O//2//Sat -------------------------------------------------------------------------------- CC pHO2Sat -------------------- ------------------------------------------- ----------------------------------- XX xX, pCO//2//xXX0, pO//2//xX0, HCTXXX, HCO//3///-/Xx+, TCO//2//X+, xXx HCO3-, TCO2, Beb, Na/+/, K/+/, iCa BEecf, O//2//SatO2Sat, tHb, iCa(N) -------------------------------------------------------------------------------- -------------------- ------------------------------------------- ----------------------------------- H3 HCT, Na/+/Na+, K/+/K+, iCa tHb, iCa(N) -------------------------------------------------------------------------------- H4 HCT-------------------- ------------------------------------------- ----------------------------------- X0 XXX, Na/+/Xx+, K/+/X+, Cl/-/Xx-, tHb BUN/Urea -------------------------------------------------------------------------------- GL/3/ tHb -------------------- ------------------------------------------- ----------------------------------- GL[3] Glu, Na/+/Na+, K/+/K+ , Cl/-/ -------------------------------------------------------------------------------- Cartridge Equilibration TimesCl- -------------------- ------------------------------------------- ----------------------------------- CARTRIDGE EQUILIBRATION TIMES: Following removal from their shiping container, XXXX cartridges must equilibrate to room temperature prior to use. Equilibration time depends on the product type as follows: --------------------------------------- Cartridge Equilibration Time --------------------- ------------------------------------- CARTRIDGE EQUILIBRATION TIME (hoursHOURS) ===================== ===================================== BG 72 --------------------------------------- --------------------- ------------------------------------- CC 72 --------------------------------------- --------------------- ------------------------------------- H3 1 --------------------------------------- --------------------- ------------------------------------- H4 1 --------------------------------------- GL/1/ --------------------- ------------------------------------- GL1 1 --------------------------------------- ---------- /3/ --------------------- ------------------------------------- --------------------- [3] Available only on XXXX Reportable Ranges REPORTABLE RANGES : The default reportable ranges for each parameter are as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- -------------------------------------------------------------------------------- MEASURED -------------------------------------------------------------------------------- pH 6.000 - 8.000 pH units ------------------------------------------------------------------- pCO//2// ------------------- ------------------------------------------------------------ pCO2 4.0 - 200.0 mmHg (0.53 - 26.6 kPa) ------------------------------------------------------------------- pO//2// ------------------- ------------------------------------------------------------ pO2 20.0 - 700.0 mmHg (2.67 - 93.33 kPa) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Hct 10.0 - 80.0 % (.100 -.800 SI) ------------------------------------------------------------------- Na/+/ ------------------- ------------------------------------------------------------ Na+ 80.0 - 200.0 (mM, mEq/L) ------------------------------------------------------------------- K/+/ ------------------- ------------------------------------------------------------ K+ 1.00 - 20.0 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa 0.20 - 5.00 mM (0.80 - 20.4 mg/dL; 0.40 - 10.00 mEq/L) ------------------------------------------------------------------- Cl/-/ ------------------- ------------------------------------------------------------ Cl- 30.0 - 150.0 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/urea (H4 P/N 055700) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN 3 - 100 mg/dL (1.1 - 3.57 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Urea 6 - 321 mg/dL (1.1 - 35.6 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/urea (H4 P/N 055703) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN 3 - 150 mg/dL (1.1 - 53.5 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Urea 6 - 321 mg/dL (1.1 - 53.4 mM) ------------------------------------------------------------------- Glu/1/ ------------------- ------------------------------------------------------------ Glu[1] 20 - 500 mg/dL (1.1 - 27.8) ------------------------------------------------------------------- Calculated ------------------------------------------------------------------- HCO//3///-/ -------------------------------------------------------------------------------- CALCULATED -------------------------------------------------------------------------------- HCO3- 0 - 99.9 mM ------------------------------------------------------------------- TCO//2// ------------------- ------------------------------------------------------------ TCO2 0 - 99.9 mM ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Beb +/- 99.9 mM ------------------------------------------------------------------- Beecf ------------------- ------------------------------------------------------------ BEecf +/- 99.9 mM ------------------------------------------------------------------- O//2//Sat ------------------- ------------------------------------------------------------ O2Sat 0 - 100% ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ tHb 3.4 - 27.2 g/dL (2.1 - 16.9 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa(N) 0.20 - 5.00 mM (0.80 - 20.04 mg/dL; 0.40 - 10.00 mEq/L ------------------------------------------------------------------- Display Resolution------------------- ------------------------------------------------------------ DISPLAY RESOLUTION: The display resolution for each parameter is as follows: ------------------------------------------------------------------- Measured ------------------------------------------------------------------- -------------------------------------------------------------------------------- MEASURED -------------------------------------------------------------------------------- pH 0.001 pH units ------------------------------------------------------------------- pCO//2// ------------------- ------------------------------------------------------------ pCO2 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- pO//2// ------------------- ------------------------------------------------------------ pO2 0.1 mmHg (0.01 kPa) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Hct 0.1% (.001 SI) ------------------------------------------------------------------- Na/+/ ------------------- ------------------------------------------------------------ Na+ 0.1 (mM, mEq/L) ------------------------------------------------------------------- K/+/ ------------------- ------------------------------------------------------------ K+ 0.01 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ iCa 0.01 (mM, mEq/L, mg/dL) ------------------------------------------------------------------- Cl/-/ ------------------- ------------------------------------------------------------ Cl- 0.1 (mM, mEq/L) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ BUN/Urea 1 mg/dL (0.1 mM) ------------------------------------------------------------------- ------------------- ------------------------------------------------------------ Glu 1 mg/dL (0.1 mM) ------------------------------------------------------------------- ---------- /1/ ------------------- ------------------------------------------------------------ --------------------- [1] Available only on XXXXXXXX EXHIBIT 2.1 PRODUCT PRICES
Appears in 1 contract
Samples: Support and Services Agreement (Koninklijke Philips Electronics Nv)