Operator's Manual, reva, English

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1 MEDICAL INSTRUMENTS

2 October 1997 AVL Scientific Corporation AVL MEDICAL INSTRUMENTS AG AVL LIST GmbH 50 Mansell Court Stettemerstrasse 28 Kleiststrasse 48 P.O. Box 337 CH-8207 Schaffhausen A-8020 Graz Roswell, Georgia USA Switzerland Austria ii

3 ! Important Information! iii

4 iv

5 1 Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990) p.98-99, , , , Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1994) pp v

6 vi

7 3 Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders. Mayo Clinic Proc. 55:606, vii

8 viii

9 ix

10 x

11 Standard A Contents: 350 ml Active Ingredients: Na mmol/l K mmol/l Cl mmol/l Ca mmol/l Li mmol/l Storage: Temperature: 5-30 C (41-86 F) Standard B Contents: 85 ml Active Ingredients: Na mmol/l K mmol/l Cl - 72 mmol/l Ca mmol/l Li mmol/l Storage: Temperature: 5-30 C (41-86 F) xi

12 Standard C Contents: 85 ml Active Ingredients: Na mmol/l K mmol/l Cl mmol/l Ca mmol/l Li mmol/l Storage: Temperature: 5-30 C (41-86 F) Reference Solution Contents: 85 ml Active Ingredients: Potassium chloride 1.2 mol/l Storage: Temperature: 5-30 C (41-86 F) Separately Packaged Reagents: Cleaning Solution A (BP1025) Contents: Each dispensing bottle contains 100 ml of solution Active Ingredients: Neodisher MA (detergent) 3.5 g/l Storage: Temperature: 5-30 C (41-86 F) xii

13 Contents: Each dispensing bottle contains 100 ml of solution (U.S. market) Active Ingredients: Ammonium bifluoride 100 mmol/l Storage: Temperature: 5-30 C (41-86 F) Contents: Each bottle contains 500 ml of solution Active Ingredients: Sodium chloride 120 mmol/l Storage: Temperature: 5-30 C (41-86 F) FOR IN-VITRO DIAGNOSTIC USE. Procedure xiii

14 xiv

15 Na + K + Ca++ Cl - (mmol/l) (mmol/l) (mmol/l) (mmol/l) (mmol/l) (mmol/24hrs) N/A N/A 4 Henry, R.J., Clinical Chemistry - Principles and Technics, (New York: Harper and Row, 1974) xv

16 5 Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p xvi

17 Material: ISE-trol Protein Based Aqueous Control Material - Level 1 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % Material: ISE-trol Protein Based Aqueous Control Material - Level 2 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % xvii

18 Material: ISE-trol Protein Based Aqueous Control Material - Level 3 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % Material: RNA EQUIL Reduced Bovine Hemoglobin Solution - Level 2 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium N/A Material: Aqueous Standard Solution - Level 1 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % Material: Aqueous Standard Solution - Level 2 Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % xviii

19 Material: Pooled Human Serum Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium % % % Material: Acetate Dialysate Solution Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium N/A Material: Bicarbonate Dialysate Solution Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium % % % Lithium N/A Material: Urine Parameter mean Swr (CV%) Sdd (CV%) ST (CV%) Sodium % % % Potassium % % % Chloride % % % ionized Calcium N/A Lithium N/A xix

20 Correlation Parameter Slope Intercept Coefficient Sy*x Range n Sodium Potassium Chloride ionized Calcium Lithium xx

21 IL 943 Flame Photometer Correlation Parameter Slope Intercept Coefficient Sy*x Range n Sodium normalized to Na = Potassium normalized to K = Lithium AVL 98X Electrolyte Analyzers Correlation Parameter Slope Intercept Coefficient Sy*x Range n Sodium normalized to Na = Potassium normalized to K = Chloride normalized to Cl = ionized Calcium normalized to ica = Lithium xxi

22 AVL 91XX Electrolyte Analyzers Correlation Parameter Slope Intercept Coefficient Sy*x Range n Sodium normalized to Na = Potassium normalized to K = Chloride normalized to Cl = ionized Calcium normalized to ica = Labconco Digital Chloridometer Correlation Parameter Slope Intercept Coefficient Sy*x Range n Chloride normalized to Cl = xxii

23 Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles Procedures Correlations, 2nd Ed., (Philadelphia: J.B.Lippincott Co.),1992,p.281. Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders. Mayo Clinic Proc. 55:606, Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1994) pp , Calbreath, Donald F., Clinical Chemistry A Fundamental Textbook, (Philadelphia: W.B. Saunders Co., 1992) pp.371, 376, Henry, R.J., Clinical Chemistry - Principles and Technics, (New York, Harper and Row, 1974) Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids and Tissue, Second Edition; Tentative Guideline. NCCLS Document M29-T2, (1992). National Committee for Clinical Laboratory Standards. Additives for Blood Collection Devices: Heparin; Tentative Standard; NCCLS Document H24-T, (1988). National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices, Second Edition; Tentative Guideline. NCCLS Document EP5-T2, (1992). Rose, Burton David, Clinical Physiology of Acid-Base and Electrolyte Disorders, 4th Ed., (New York: McGraw-Hill, Inc., 1993) pp , 432, Schoeff, Larry E & Williams, Robert H. (Eds.) Principles of Laboratory Instruments, (St. Louis: Mosby Year Book Inc., 1993) pp , Snyder John R., Senhauser Donald A, (Eds.), Administration and Supervision in Laboratory Medicine, 2nd Ed, (Philadelphia: J.B.Lippincott Co., 1989) pp Tietz, Norbert W.,Ed.,Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B. Saunders Co., 1990), pp.98-99, , , , Tietz, Norbert W.,Ed., Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1986), pp.1816, 1837, , Toffaletti J, Gitelman JH, Savory J: Separation and quantification of serum constituents associated with calcium by gel filtration. Clin Chem 22: , xxiii

24 Welcome xxiv

25 xxv

26 Chapter 1 1

27 2

28 Na + K + : Sodium : Potassium Cl Ca ++ Li + : Chloride : Calcium : Lithium Na K Cl READY 3

29 4

30 Ref : Reference Na + : Sodium K + : Potassium Cl : Chloride Ca ++ : Calcium Li + : Lithium 5

31 6

32 7

33 Chapter /8" 13 3/4" 13" 8

34 9

35 10

36 11

37 12

38 13

39 Date: 01-JAN -80 Time: 00:00 14

40 15

41 16

42 17

43 18

44 [ Na ] [ K ] [ ] ok? 19

45 Chapter 3 20

46 21

47 22

48 23

49 Na + : mmol/l 1 K + : mmol/l 1 Cl - : mmol/l 2 Ca ++ : mmol/l 1 Li + : mmol/l 1 1. Tietz, Norbert W., Ed. Clinical Guide to Laboratory Tests, 2nd edition (Philadelphia: W.B. Saunders Company, 1990), pp. 98, 456, 510, Henry, R.J., Clinical Chemistry - Principles and Technics, (New York: Harper and Row, 1974). 24

50 25

51 Ca low = 1.12 Ca high = 1.32 ok? Li low = 0.60 Li high = 1.20 ok? 26

52 Na(b) = Na(m) = ok? 27

53 28

54 29

55 30

56 31

57 Chapter 4 32

58 33

59 Na K fl Cl

60 35

61 Chapter 5 Na + K + Cl - Ca ++ Li + Sodium Potassium Chloride Calcium Lithium 36

62 37

63 38

64 * AVL 9180 * ELECTROLYTE ISE NA - K - LI 01MAR96 07:20 Name: Sample: SERUM Sample No. 4 Na = 190 mmol/l K = 5.2 mmol/l Li = *** mmol/l *** Li calculation not possible 39

65 40

66 * AVL 9180 * ELECTROLYTE ISE NA - K - CL 25MAR96 16:55 Name: Sample: URINE Sample No. 1 Na = 263 mmol/l K = 18.3 mmol/l Cl = 118 mmol/l * AVL 9180 * ELECTROLYTE ISE NA - K - CL 02MAR96 10:07 Name: Sample: URINE Sample No. 5 Na = 142 mmol/l K = mmol/l 41

67 Chapter 6 42

68 43

69 44

70 45

71 46

72 47

73 48

74 49

75 50

76 51

77 52

78 53

79 54

80 55

81 56

82 All Electrodes & Plug Removed? 57

83 58

84 59

85 Chapter 7 60

86 61

87 62

88 CHECK REFERENCE HOUSING PLEASE CLOSE SAMPLE DOOR NO SAMPLE 63

89 CLEANING FLUID NOT DETECTED 64

90 CONDITIONING FLUID NOT DETECTED INTERFACE ERROR 65

91 PAPER JAM OR PRINTER DEFECT CHECK ELECTRODES 66

92 NA NOT CAL D K NOT CAL D CL NOT CAL D CA NOT CAL D LI NOT CAL D CLOG CHECK FLUID PATH 67

93 68

94 ERR. PERFORM DAILY MAINTENANCE CHANGE FLUID PACK 69

95 *** LI CALCULATION NOT POSSIBLE CHECK TEMP (Ca ++ activated) 70

96 Testing the electrodes A-B A-C Na to to to to to +50 K to to to to to +40 Cl to to to to -860 not used Ca to to to to to +150 Li to to to to to

97 Testing the sample sensor Testing the sample door Testing SnapPak Sensor 72

98 Testing the language switch Testing the peristaltic pump Testing the valves 73

99 Testing the interface Testing the amplifier 74

100 Service Codes DEC ECO 75

101 FIF LEM NOB SLC 76

102 SFC SnapPak Counter: xxx% ok? QCC 77

103 Chapter 8 78

104 79

105 R T 1. E = E ± In a i n F R T 2. E = E ± In (f n F 3. E=E ± S log (f i c i ) E E a R T n F f c i S 80

106 4. E 5. E standard = E + S log (f i c i standard ) 6. E = E sample - E standard = S log c i sample c i standard E S c c i standard ( E / S) 7. c i sample = c i standard 10 81

107 8-1. Na + K + Cl - 82

108 83

109 84

110 85

111 86

112 87

113 88

114 89

115 Chapter 9 90

116 91

117 92

118 Appendix A Sodium mmol/l 1 or 0.1 mmol/l Potassium mmol/l 0.1 or 0.01 mmol/l ( mmol/l dialysate) Chloride mmol/l 1 or 0.1 mmol/l ionized Calcium mmol/l 0.01 or mmol/l Lithium mmol/l 0.01 or mmol/l Na + CV mmol/l K + CV 4-6 mmol/l Cl CV mmol/l Ca ++ SD mmol/L Li + SD mmol/L Sodium mmol/l 1 mmol/l Potassium mmol/l 0.1 mmol/l ( with additional dilution) Chloride mmol/l 1 mmol/l Na + CV mmol/l K + CV mmol/l Cl - CV mmol/l 93

119 335 x 315 x 295 mm Safety category I Device type B (according to ÖVE-MG/EN , IEC 601-1) Mode of operation continuous operation Protection classification IP 20 Approvals CSA, IEC 1010 (TÜV/GS), CE, FCC Class B 94

120 Appendix B Na K Cl READY No No No No No No No No Yes Yes Yes Yes Yes Yes Yes QC Level 1 AAA No No No No No No QC Level 2 No No No No No No No QC Level 3 No Yes No No No No Yes No No No No No No No No No No No No No Yes No No Yes No No No No No No No No No Yes No No Yes No. 95

121 Appendix C 1) 1) 2) 2) AVL 9181 ELECTROLYTE ANALYZER

122 Appendix D Parameter: Low Level / reference device Low Level / AVL Meas. No. 1 Meas. No. 1 Meas. No. 2 Meas. No. 2 Meas. No. 3 Meas. No. 3 sum 1, 2, 3 sum 1, 2, 3 sum 1, 2, 3 sum 1, 2, 3 High Level / reference device High Level / AVL Meas. No. 1 Meas. No. 1 Meas. No. 2 Meas. No. 2 Meas. No. 3 Meas. No. 3 sum 1, 2, 3 sum 1, 2, 3 sum 1, 2, 3 sum 1, 2, 3 m = d : c m = d : c 97

Operator's Manual, rev.a, English

Operator's Manual, rev.a, English MEDICAL INSTRUMENTS AVL 9181 October 1997 Copyright, 1997, AVL Scientific Corporation. AVL Scientific Corporation AVL MEDICAL INSTRUMENTS AG AVL LIST GmbH 50 Mansell Court Stettemerstrasse 28 Kleiststrasse