CRT 16 Quick Reference Guide

Transcription

1 CRT 16 Quick Reference Guide Service Version Rev 03/30/01 Main Tests/Analyzer Option & Modes: Tests: Measured: Calculated: Na, K, Cl, TCO 2, Gluc, BUN (Urea), Creat, Hct Osmolality, BUN/Creat Ratio, Anion Gap Options: Analyzer Configurations: Stand-Alone (w/ or w/out Printer) Auto-Sampler (Cups-Only, or Primary Tube) (non-urine) Dilutor Option (Auto-Sampler plus Urine Diluting Option) Modes: Sample Types: Whole Blood (WB), Serum/Plasma, Urine, CSF (no MicroSample Option) Slope Limits: Na: 8.8 to 11.6 (1,7) K: 8.7 to 11.7 (5,8) Cl: 8.5 to 13.0 (1,4,5) TCO 2 : 8.0 to 14.5 (1,2,3,5) Gluc: 5.0 to 65.0 (1,2,3,7) BUN: 8.8 to 13.1 (1,3,7) Creat: 30.0 to (1,2,3,7) Hct: 5.0 to 20.0 (1,6,7) Notes: 1 = Long Life Electrode 2 = Int'l Ref Electr ode 3 = Membrane Cap; Push-On 4 = Membrane Cap; Screw-On 5 = Uses Washer 6 = Impedence (Air Detector) 7 = No Washer 8 = Mid-Range Life Flow Limits: Calibration: (seconds) Analysis: (seconds) Offset Limits: Slope/Intercept Used. Analysis Time/Rate: Analysis Time: 90 sec {published specification; not including Probe flush at start} 95 sec {full analysis time w/ "normal" Gluc/Creat range samples} {Extra rinse "F" cycles added for high Gluc/Creat increasing times) Maximum Time: 125 sec (full "F" rinse cycles added) Analysis Rate: 40 samples/hour (WB/Serum/Plasma) {Best Case: normal range samples; based on 90 sec time} 15 samples/hour (Urine Mode)

2 Quick Reference (CRT 16): Continued Sample Volume: WB, Serum/Plasma, CSF: Urine (before dilution) 385 ul. 100 ul. Dilution Ratios: Urine Dilution (final concentrations): All Tests (except BUN, Creat): 1:6 (one cup needed) BUN/Creat: 1:36 (two cups needed) Software Version: 3.13 (English & German only) 03/2001 (Italian/Japanese/French: Pending) Septum Positions: (6 position septum) Electrode/Flowcell Positions: Top: Std C Top: TCO 2 {Flowcell & Electrode} Std B Mixer Std A Reference D-Solution Cl {Main Flowcell} L-Solution BUN {Main Flowcell} Bottom: Flush Gluc {Main Flowcell} (non-septum) Air (outside) Creat {Main Flowcell} (non-septum) Sample (Probe out) K {Main Flowcell} Na {Main Flowcell} Bottom: ADET/Hct Fluids Details: Std A and B: Used to calibrate all electrodes except TCO 2.. Varying analytes concentrations included. (Preservative added.) Std C: Used to calibrate TCO 2; ; also in flowpath during idling and also used for some wash-out. Required for good stability of Gluc & Creat. (Preservative added.) Flush: Used to rinse flowpath during/after analysis cycles; may use more than 1 flush sequence if Gluc and/or Creat sample concentrations are high. H-Solution: Connects to Mixer; is an acid solution for conversion of HCO3- in sample to CO2 gas for transport into TCO2 electrode. Reference Solution: Connects to reference electrode; 2 M KCl. D-Solution: In optional 'Dilutor Pack'; urine diluent solution. L-Solution: In optional 'Dilutor Pack'; urine one-point cal standard.

3 Quick Reference (CRT 16): Continued Linear Ranges: WB/Serum/Plasma: CSF: Urine: Na: 80 to 200 mmol/l n/a 10 to 300 mmol/l K: 1 to 10 mmol/l n/a 10 to 300 mmol/l Cl: 60 to 200 mmol/l 60 to 200 mmol/l 20 to 300 mmol/l TCO2: 5 to 50 mmol/l n/a n/a Gluc: 25 to 500 mg/dl 25 to 500 mg/dl n/a BUN: 3 to 100 mg/dl n/a 100 to 1500 mg/dl Creat: 0.2 to 20 mg/dl n/a 10 to 400 mg/dl Hct: * 15 to 65 % n/a n/a * (Whole Blood Only) Pump/Valve Requirements: Pumps: Always 2 Pumps Valves: Only Waste Valve; No Pinch Valve Assembly required (for any configuration). Dependency Rules & Information: { Hct Measurement: Requires calibrated (no errors) Na+ channel for Hct reporting. { BUN Measurement: Requires calibrated (no errors) Na+ and K+ channels for BUN reporting. No separate NH4+ slope shown/required (as with CRT 12/14). { TCO2 Measurement: Requires calibrated (no errors) Hct channel for TCO2 correction. Assume: 12 < Hct % < 70 (for whole blood samples) Hct < 12 (acceptable for serum/plasma samples) Proper "Sample Type" must be selected to match sample or "Mismatch Error". { Standby Mode: NOT available on CRT 16. { Passwords: Password options for analysis available (like STP/Ultra) (47 unique passwords). If enabled, password required after pressing ANALYZE. Special "supervisor" password; Only "supervisor" password accesses Setup Menu. "TEXT" key ENABLES/DISABLES password protection (from Password menu). { Dialysate "Sample Type" not available on "Sample Type Key"; use 'Serum/Plasma' for dialysate selection. Updates: Current policy: Updates to CRT 16 will only be allowed from CRT 12/14 units. Updates will require that units have current "ADC FAM Chip PEEL Device (U37; ver >2.1) and "ANP ROM Chip" (U50; ver > 3.0) on the Main Controller Board. Chips must be replaced on all units with older version chips to operate as a CRT 16.

4 Calibration Information: 2 Point Calibration: (Turned off in Standby ) Fixed: Done automatically each TWO (2) Hours. Manual: At any time by pressing Calibrate key. 1 Point Calibration: Done with EACH sample analysis. Standby Mode: Manual entry and exit (via sub-menu option). All calibrations turned off in Standby Mode. Idle pumping done only. Sample & QC Storage: Stat Mode: Tray (Autosampler) Mode: Serum: Urine: Holds last 80 samples (FIFO). Holds one tray (40 cups/samples). 12 Urines/Tray Max. QC Analysis: Recommended: One (1) Level Start of Each Shift/Every 8 Hours ('Ideal': "Nova Chemistry Control + Creat" 2 levels, plus Hct Controls 2 levels) Chemistry Controls Pus Creatinine: (Store FROZEN; Good for 14 days open-vial refrigerated) Multipack: Levels 1 & 2 only Level 3: Optional QC (sold separate; high range) QC Files/Libraries: Seven (7) QC Files Plus Proficiency on all CRT: Files 1-7: For QC data storage: ( Open QC files: Can program w/ any QC matl) File 0: Proficiency samples & Performance Check Solution only.

5 CRT 16 Creatinine Electrode Theory Relevent Chemical Reaction: Creatinine Amidohydrolase (Enzyme) Creatinine + H 2 O > Creatine Creatinine Amidohydrolase (Enzyme) Creatine + H 2 O > Sarcosine + Urea Sarcosine Oxidase (Enzyme) Sarcosine + O 2 + H 2 O > Formadehyde + Glycine + H = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = V H 2 O > 2 H+ + O e- [2 e-] = Proportional to amount of Creatinine. = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Creatrinine Creat Membrane > H2O2 Electrode Creatrinine Creatrinine > > H2O2 H2O2 2 e-

6 Quick Reference (CRT 16): Continued CRT 16 Electrode/Standards Information: Rev: 02/29/96 Electrode Standards Used in Approximate Delta mv Calibration/Slope (between standards) Na Stds A & B 14 K Stds A & B 21 Cl Stds A & B 13 TCO2 Stds A & C 20 Gluc Stds A & B 175 BUN Stds A & B 25 Creat Stds A & B > 400 Hct/ADET Stds A & B > 300

7 General Maintenance/QC: CRT 16 Maintenance Summary Page 1 of 6 Rev 03/30/01 1. Clean sample inlet port/base of Septum. (AS NEEDED) 2. Flowpath Conditioning. (AS NEEDED) (Use serum/plasma/whole blood: Automated Cycle) a.) Done daily for low-mid volume users. b.) Not required for higher volume users. 3. Control Analysis. (DAILY) "Nova Chemistry Controls + Creat : 2 levels (Multipack) liquid control; stored frozen, shipped with Ice Packs. (Open Vial Life: 2 weeks refrigerated) ** 3rd QC Level (high QC; sold separately) ** "Best" control: Stable TCO2 & Creat balance for CRT electrodes. Hct Controls: 2 levels (STP version; aqueous) 4. "Performance Check Solution" (Glucose/BUN/Creatinine): (DAILY) New material: Stored frozen/shipped w/ Ice Packs; in ampules for single use. a.) Notes: As membrane ages, very high end results may appear 'normal' due to lower activity (Gluc). BUN can show falsely higher OR normal results with high-end samples as membrane ages so BUN has "range value" to verify. Creatine added to solution to verify Creat Membrane can differentiate between Creatine and Creatinine. b.) Testing Results: (must check results on "Sensor Data" Screens) Gluc: > 700 mg/dl (> 38.9 mmol/l) for acceptable membrane (other CRT models: > 700 mg/dl) BUN: > 100 (> 71.4 mmol/l) for acceptable membrane (other CRT models: > 100 mg/dl) Creat: < 1.6 mg/dl (< 142 umol/l) for acceptable membrane 5. Linearity Standards: (AS NEEDED) "Linearity Stds 'SET F'": (4 levels including ALL parameters plus Creat) Used exclusively on CRT 16. Stored frozen; shipped w/ Ice Packs. Run to verify linearity &/or for troubleshooting. NOT ROUTINE. 6. Probe/Air Dectector Cleaning/Flushing. (WEEKLY) a.) Press FLOWPATH; Remove ADET from Flowpath b.) Clamp R & H tubings (going into electrodes) with hemostat/clamp. c.) Flush from ADET down through S-Line/Probe w/ Cleaning Soln (PN 11272). d.) Let sit 2 minutes. Then Flush with water (x2) and air (x1). (Continued)

8 CRT 16 Maintenance Summary General Maintenance/QC (Continued): Page 2 of 6 Probe/Air Dectector Cleaning/Flushing (continued): e.) Attach syringe/tubing to TCO2 Flowcell port, and flush downward with water through flowpath. f.) Flush the flowpath with air, then reconnect the W-line and unclasp R/H lines. Exit Flowpath and calibrate. Flowpath Cleaning. (AS NEEDED) a.) Non-automated cleaning of entire flowpath. b.) Build-up of protein/wastes common at Na, Mixer, Reference, TCO2 areas c.) Procedure (notes) 1) Go to 'Flowpath Maintenance' (Probe is slightly outside Septum). 2.) Clamp R & H tubings (going into electrodes) with hemostat/clamp. 3.) Disconnect W-line from top of TCO2 Flowcell. 4.) Place cup/beaker under Septum/Probe. 5.) Attach syringe/tubing to TCO2 Flowcell port, and flush downward with water through flowpath. 6.) Flush with air, then reconnect W-line and unclasp R/H lines. Exit Flowpath and calibrate. d.) Done AS NEEDED (officially) for routine. "Best" if done ONCE/WEEK routinely combined with Na+ Conditioning. e.) Done as first troubleshooting step for flow/clog problems. f.) Combine with Na Conditioning on monthly schedule. 7. Mixer Cleaning: (AS NEEDED) a.) Semi-automated cycle with instructions on use of fluids/tubing connections. b.) Frequency: Done AS NEEDED (officially). "Best" if done ONCE/MONTH for serum users; EVERY 2 WKS for Plasma/WB users. c.) Cleans Mixer and TCO2. (manual cleaning of Reference is recommended). 8. Sodium Conditioning: (TWICE/WEEK) a.) Condition (with Na/pH Cond Solution) TWICE/WEEK. b.) Manual removal, soak 2 minutes in Na/pH Conditioning Soln (PN 00018). Access "Flowpath" for fluid purge before electrode removal. Do in conjunction with Flowpath Cleaning c.) Condition NEW electrode before use.

9 CRT 16 Maintenance Summary (continued) Electrode Maintenance Information: Page 3 of 6 Sodium (Na): { STP Electrode (same). { Condition (with Na/pH Cond Solution) TWICE/WEEK (combine with ADET cleaning). { Condition NEW electrode before use. { Use PN Na/pH Cond Soln (EL/CRT/NUC version). Potassium (K): { Mid-life electrode (Range: Life = 3-9 months typical). { STP Electrode (same). { Flowpath conditioning (blood) will improve life/slope; done as needed. { Has Flowcell Washer (STP type). Chloride (Cl): { Electrode and Cap; STP same. { Has Flowcell Washer (STP type). { Cap = Short Life (Range: Life = 2-8 weeks). Change only AS-NEEDED (slope/results). { Cap Replacement: Fill cap to very TOP of threads with Cl IFS. Total CO2 (TCO2): { Electrode and Cap: New Design.; Electrode = Long Life (Range = 1-4 years) { Cap = Short Life (Range: Life =2-12 weeks). Change only AS NEEDED (slope/results). { Cap Replacement: Push-On type (similar to pco2 STP); must degas/shake-down & Flowpath Condition before calibration. Fill cap with TCO2 IFS to slightly below line above Vent Hole. { Conditioning with pco2/tco2 Conditioning Solution upon install of NEW electrode and/or for troubleshooting ONLY. (Soak for 15 minutes outside unit as required) { TCO2 Flowcell: Separate part from TCO2 electrode/membrane. { Has Flowcell Washer (new design). BUN/Urea: { Electrode (new version; longer wire than STP); Membrane (new design). { Push-On Membrane Cap: Replace AS-NEEDED based on slope/results/overrange soln. { Electrode: Range: Life = 1-2 years; Membrane: Range: Life = 2-8 weeks. { Run Overrange Solution daily to verify membrane/results. { Polishing NEVER done. { Membranes stored in refrigerator; shipped non-refrigerated.

10 CRT 16 Maintenance Summary (continued) Electrode Maintenance Information (continued): Page 4 of 6 Glucose (Gluc): { Electrode (STP same); Membrane (CRT 12 same). { Push-On Membrane Cap: Replace AS-NEEDED based on slope/results/overrange soln. { Electrode: Range: Life = 1-3 years; Membrane: Range: Life = 2-8 weeks. { Run Overrange Solution daily to verify membrane/results. { Auto-Polishing done daily or on-demand on CRT 16; time selectable. { Manual Electrode Polishing: for Troubleshooting Only. a.) Polishing 'Conditions': ** Consistently cannot recover > 700 mg/dl on Overrange Solution. ** Chronic slope and/or results problems not resolved by membrane changing. b.) Polishing Procedure: ** Polish using only new YELLOW (1 u) Polishing Paper only. ** Polish for 10 seconds (use H20 and Polishing Paper) ** Condition for 2 minutes in CRT Cleaning Solution. ** Rinse with H20 and 'blot' dry. { Membranes stored in refrigerator; shipped non-refrigerated. Creatinine: { New electrode/membrane (can use STP glucose electrode to troubleshoot if required). { Push-On Membrane Cap: Replace AS-NEEDED based on slope/results/overrange soln. { Electrode: Range: Life = 9-24 months; Membrane: Range: Life = 5-14 days. { Run Performance Check Solution daily to verify membrane/results. (Perf Check Solution: Heat sensitive for Creat: Stored FROZEN; ship ICE) { Auto-Polishing done daily or on-demand on CRT 16; time selectable. { Manual Electrode Polishing: NEVER TO BE DONE ** Change electrode for Overrange Soln results problems and/or slope/qc problems not resolved through membrane change. { "Chloridizing" of Electrode: (Done with new electrode install and EACH time membrane is replaced.) a.) Immerse in "Electrode Cleaning Solution" (PN 11272) for 2 minutes min. b.) Rinse with water; blot dry only, do NOT wipe. c.) Metallic ring should be dull; not bright. { Membranes heat sensitive: Stored FROZEN; shipped w/ Ice Packs &/or Dry Ice. { Storage (Membranes): Refrigerate (2-4 C) { Shipment to Dealers: Dry-Ice/Ice-Packs; To Customers Should use only ice. { Can store large quantities of membranes frozen. { Membrane Warranty = 3 days or 200 samples. (CONTINUED)

11 Electrode Maintenance Information (continued): Page 5 of 6 Creatinine (Continued): { To replace Creat Membrane: * Replace membrane in "Flowpath Maintenance" cycle. After completion, exit Flowpath wait 10 minutes. * After 10 minute wait, perform 3 calibrations minimum. If after 4th cal calibration, slope is still unacceptable, replace membrane again (must Chloridize electrode also). HCT/Air Detector: { Same as CRT version (Hct Detector). { Has heater circuit; only used for Hct, non-electrode dependent. { CRT 16 does not have automated "Probe (ADET) Cleaning Cycle" (must do manual ADET cleaning; see "Cleaning Maintenance" notes). { Clean ADET (manually) AS NEEDED (officially). "Best" if done ONCE/MONTH. Reference Electrode: { New version (CRT type with connector wire). { In-line between 'Main Flowcell' and Mixer. { Clean (manually) in conjunction with 'Mixer Cleaning' maintenance (more for plasma/wb users). Mixer Assembly: { New design; non-stp or CRT. { Similar function of CRT: mixes H-solution (acid) with sample for CO2 gas liberation. { 'Mixer Cleaning' cycle same as CRT models { Frequency: Done AS NEEDED (officially). "Best" if done ONCE/MONTH for serum users; EVERY 2 WKS for Plasma/WB users.

12 Fluid Pack Information: CRT 16 Maintenance Summary (continued) Page 6 of 6 Activation: { Stds A,B,C are BAG fluids with 2 pouches: one liquid section, and one powdered section. Clip dividing pouches must be removed before use and contents combined and thoroughly mixed. Pack Life/Use: { Pack (RMS tracking) good for 21 days from RMS pod install (activation). { Date pack "activated" (RMS pod installed) denoted on RMS (Fluid Pack Change) screen. { 2-3 week used life "estimated" at full pack usage with volume of almost 0 samples/day. Pack may be used after "expired" date: unit simply denotes pack expired on both Base Screen AND Fluid Pack Change screen. Use beyond RMS expiration based on: * Creat results usage dependent on control and overrange solution results. * Other parameters unaffected by Use Life issue and can be used until pack end. Other Information: { Stds A/B/C: Used for calibration of all analytes. { Stds A/B/C: Have bacterial/fungal preservative added. { Other Fluids: No preservatives added. Other Maintenance Items: Tubings: { W/R/H Pump Tubings: Change every 3 months. { Tubing Harness: Change every months. { Septum: Change with every fluid pack (Not recommended to run more than one (1) month. Increased septum wear with CRT 16 since Probe must move all the way out for air aspiration vs. position # 3 on all other CRT models.) { Probe: Change yearly or as needed.

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