For veterinary use only Use after reading this “Instructions for Use” FUJI DRI-CHEM SLIDE Comprehensive S-Panel (TP,ALB,ALP,GLU,TBIL,IP,TCHO,GGT,GPT/ALT,Ca,CRE,BUN) Date of issue: 1/Sep/2013 [Warnings and precautions] 1. Only the required number of S-Panel packages should be taken out of the refrigerator and warmed up to room temperature before opening the individual packages. 2. Do not damage a package of dry silica gel and the binding tape, when you open the S-Panel package especially with scissors. 3. A new package must be used for each measurement. Do not reuse. 4. Use immediately after opening the S-panel package. 5. Do not use slides that fell on the fl oor as it could be contaminated. 6. Do not touch either the center part of the surface or the back of the slide. 7. Do not use the slide if the individual package is damaged. 8. Keep QC card away from magnetic materials. 9. Handle all patient specimens, control serum and used tips carefully as biohazardous samples. Wear proper gloves, glasses and other pro- tective gear for your safety. 10 . Used slides are categorized as infectious waste. Make sure to dispose them in accordance with the Waste Disposal Law and other related regulations, which prescribe the proper method of disposal, such as incineration, melting, sterilization or disinfection. 11 . Make sure to dispose dry silica gel in accordance with the Waste Disposal Law and other related regulations. 0 [Additional special equipment] 1 Analyzer: FUJI DRI-CHEM ANALYZER 3 Other implements: FUJI DRI-CHEM QC CARD (attached) 0 : FUJI AUTO TIPS 1 : FUJI HEPARIN/PLAIN TUBE or Blood collection tube speci fi ed in the “INSTRUCTION MANUAL” for FUJI DRI-CHEM ANALYZER 9 1 [Procedure] 1. Unwrap the package. Be sure to open gently from “V shaped” notch as Comprehensive shown in the fi gure. Do not rip the included pack of dry silica gel. S-Panel 2. Take out slides from package. Do not touch either the center part of ��������� ��������������� the surface or the back of the slide. 3. Place slides to be tested, barcode surface down, in the slide cartridge. Be sure to place an edge of the binding tape on the outside of the slide cartridge as shown in the fi gure. 4. Be sure to put the slide weight on top of the stacked slides. 5. Hold an edge of the binding tape. Pull out and remove the binding tape from the slide cartridge. 6. Make sure the binding tape is removed completely from the slide cartridge. 7. Place the slide cartridge on the analyzer. 8. Read in the new QC-card when you switch to a new box of slides. 9. Set a sample tube in the speci fi ed sample rack. 10. Input a sequence No. and a sample ID if appropriate. 11. Press the “START” key to initiate testing. For further details of operation procedure, consult “INSTRUCTION MANUAL” for FUJI DRI- CHEM ANALYZER. [Storage and shelf life] 1. Storage: This product must be stored between 2-8 ℃ (35.6-46.4 ℉ )before use. 2. Expiry date is printed on the carton and the individual packages. [Contents] Slide: 6 Panels/12 slides per Panel QC card: 1 Desiccant: 1 silical gel pack per Panel
For veterinary use only Use after reading this “Instructions for Use” FUJI DRI-CHEM SLIDE Comprehensive S-Panel (TP, ALB, ALP, GLU, TBIL, IP, TCHO, GGT, GPT/ALT, Ca, CRE, BUN) Date of issue: 1/Sep/2013 n TP [Composition of the slide] [Performance characteristics] 1. Multi-layered structure 1. Dynamic range 2.0–11.0 g/dL (20–110 g/L) Specimen 2. Accuracy Concentration range Accuracy 2.0–5.0 g/dL Within ±0.75 g/dL Spreading layer (20–50 g/L) (Within ±7.5 g/L) Reagent layer Transparent support 5.0–11.0 g/dL Within ±15 % (50–110 g/L) Barcode side 3. Precision Concentration range Precision 2. Ingredients per slide 2.0–5.0 g/dL SD 0.25 g/dL • Cupric sulfate pentahydrate 1.7 mg (6.9 μ mol) (20–50 g/L) (SD 2.5 g/L) 5.0–11.0 g/dL CV 5 % [Intended use] (50–110 g/L) Quantitative measurement of total protein concentration in plasma or serum. 4. Known interfering substances For veterinary use only. The effects on the measured value were examined by adding substances as shown below to a serum sample obtained from a healthy volunteer or a control 0 [Principle of the measurement] serum. No signi fi cant effect was observed to the following concentration for each 1 10 μ L of plasma or serum is deposited on a FUJI DRI-CHEM SLIDE TP-P Ⅲ . substance. 3 After depositing, the specimen spreads uniformly on the special spreading layer Ascorbic acid 10 mg/dL (0.57 mmol/L) 0 20 mg/dL (340 μ mol/L) and reacts with the reactive reagent that was released from the reagent layer to Bilirubin 1 form color. The slide is incubated at 37 ℃ for a fi xed time in the FUJI DRI-CHEM Hemoglobin 1000 mg/L 9 These results are representative; ANALYZER and the optical re fl ection density is measured at 540 nm. The optical 1 • Test condition may have some in fl uence on your results. re fl ection density is then converted into the total protein concentration using a • Interferences from other substances are not predictable. calibration curve preinstalled in the analyzer. Alkaline Comprehensive [Internal quality control] Protein + Cu 2+ Red purple color The accuracy and precision of this product can be evaluated with FUJI DRICHEM S-Panel CONTROL QP-L and/or QP-H. [Specimen requirements] 1. Select control level in accordance with your purpose. 1. After collecting the blood sample, immediate measurement is recommended. 2. Measure FUJI DRI-CHEM CONTROL QP-L and/or QP-H in the same way as 2. For plasma, heparin can be used as the anticoagulant. When using heparin, patient specimens. less than 50 units of heparin should be used per 1 mL of whole blood. Do not 3. When the results obtained are outside the expected range shown in the sheet use EDTA salt, sodium fl uoride, citric acid, oxalic acid and monoiodoacetic attached to FUJI DRI-CHEM CONTROL QP-L or QP-H, investigate the cause. acid. For additional information, consult “Instructions for Use” for FUJI DRI-CHEM 3. Avoid using plasma or serum with precipitate such as fi brin. CONTROL QP-L or QP-H. 4. Do not use hemolytic plasma or serum. 5. When the measured value exceeds the upper limit of the dynamic range, dilute [Traceability of calibrators and control materials] the sample 2 times with distilled water or saline. Since the data obtained by Total protein…NIST (SRM927) dilution may deviate more widely than usual, the data should be treated as Note: This reference material is applied to the reference method of FUJIFILM estimation. Corporation and is not directly applicable to FUJI DRI-CHEM SLIDE. NIST: National Institute of Standards & Technology
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