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DRAFT 20 June 2005

Page B - 6

Jaundice Meter (JM-103) User Manual (usr070)

Graph 4 – Regression Analysis, Doctors’ Office #2

JM-103 Regression Analysis

Doctor's Office No.2

-5

Serum Bilirubin TSB (mg/dl)

-103 R

eadi

TcB

Regression Line

Upper Limit

Low er Limit

Data Points

Regression Analysis Statistics

Sample Size = 68

Y = 0.646 +0.859 X

Root MSE = 1.475

R-Square = 0.769

95% CI for the Intercept = (-0.846, 2.138)

95% CI for the Slope = (0.743, 0.974)

Содержание JM-103

Страница 1: ...full understanding of the performance characteristics of this equipment the user should carefully read this manual before operating Model JM 103 Operating Instructions Jaundice Meter Konica Minolta D...

Страница 2: ......

Страница 3: ...Features 2 8 Specifications 2 9 Standard Features 2 9 Regulations Standards and Codes 2 10 Device Classification 2 10 Electromagnetic Compatibility EMC Guidance and Manufacturer s Declarations 2 11 S...

Страница 4: ...Access Areas 6 1 Disinfecting 6 2 Maintenance 6 2 Replacement Parts 6 2 Storage and Handling 6 3 Disposal 6 3 Section 7 Troubleshooting Service Calls 7 1 Error Messages 7 1 Troubleshooting 7 2 Append...

Страница 5: ...ct patient or user safety Disregarding a warning could result in patient or user injury A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage The...

Страница 6: ...lectrical Shock Hazard Warning The symbol below indicates INPUT RATING Input Rating Symbol The symbol below indicates that the product uses a RECHARGEABLE BATTERY Rechargeable Battery Symbol The symbo...

Страница 7: ...onjunction with other clinical signs and laboratory measurements Newborn infants whose Jaundice Meter JM 103 test results are indicative of hyperbilirubinemia should be evaluated by their physician s...

Страница 8: ...tenance and troubleshooting of the Jaundice Meter JM 103 Konica Minolta Dr ger Medical cannot be responsible for the performance of the Jaundice Meter if the user does not operate the unit in accordan...

Страница 9: ...hat the bilirubin in the subcutaneous tissue may measure low for areas with minimal blood flow or areas in which the subcutaneous tissue is subject to keratinization Although correlation with serum bi...

Страница 10: ...n pigment and the skin maturity When the measuring probe is pressed against the forehead or sternum of the infant the built in xenon lamp flashes The light from the xenon lamp passes through the glass...

Страница 11: ...d to the estimated bilirubin concentration and is indicated digitally The Jaundice Meter JM 103 device software uses a correlation coefficient to convert the measurement difference from the dual optic...

Страница 12: ...ors that could affect performance of the device or appropriate action levels include skin color age or measurement site The bias relative to serum bilirubin differs between hospital versus physicians...

Страница 13: ...Function A Power switch Turns the Jaundice Meter on and off When used with the Reset button the device switches to Check Mode and changes the unit of measurement B Ready lamp Illuminates to indicate t...

Страница 14: ...G Strap attachment area Is where the strap attaches H Checker cover Open this checker cover to check the Jaundice Meter I Charger lamp Illuminates to indicate that the Jaundice Meter is charging J DC...

Страница 15: ...r than 20 mg dl the display shows and the physician should be contacted D Unit of measurement Displays the unit of measurement in either milligrams per deciliter mg dL or micro moles of solute per lit...

Страница 16: ...20 June 2005 Page 2 8 Jaundice Meter Model JM 103 User Manual usr070 Standard Features Jaundice Meter JM 103 Charger unit Model JM A30 with a checker AC adapter Model JM A31 Carrying case and wrist s...

Страница 17: ...50000 measurements Sensors Silicon photodiodes Power source 2 4 V Special Ni MH battery Protection type and level Internally powered instrument BF type Minimum number of measurements when fully charge...

Страница 18: ...be confirmed by other methods such as laboratory blood serum analysis Regulations Standards and Codes In North America With respect to electrical shock fire and mechanical hazards only this instrumen...

Страница 19: ...st Compliance Electromagnetic Environment Guidance Radiofrequency RF emissions CISPR 11 Group 1 The Jaundice Meter JM 103 uses RF energy only for its inter nal function Therefore its RF emissions are...

Страница 20: ...netic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV con tact 8 kV air 6 kV con tact 8 kV air The floors should be wood concrete or ceramic tile If floors are covered with synthet...

Страница 21: ...tinued operation during power mains interrup tions it is recommended that the unit be powered from an uninterruptable power supply or battery Power fre quency 50 60 Hz magnetic field IEC 61000 4 8 3...

Страница 22: ...hould be used no closer to any part of the Jaundice Meter JM 103 including cables than the recommended separation distance cal culated from the equation applicable to the frequency of the transmitter...

Страница 23: ...transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the unit is used exceeds the applicable RF compliance level observe the unit t...

Страница 24: ...DRAFT 20 June 2005 Page 2 16 Jaundice Meter Model JM 103 User Manual usr070 NOTES...

Страница 25: ...ce and contact the nearest authorized service facility Failure to do so could result in fire personal injury or equipment damage WARNING Do not use the Jaundice Meter after initiation of phototherapy...

Страница 26: ...mage could occur CAUTION Do not allow blood or other liquids to come in contact with the instrument Should blood or other liquids come in contact with the instrument immediately clean the instrument s...

Страница 27: ...res may include antistatic clothing and shoes the touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves All staff involved in the abov...

Страница 28: ...eter JM 103 Use them only when charging the instrument Using them to charge other equipment could result in personal injury or equipment damage WARNING Only facility authorized personnel should troubl...

Страница 29: ...unplug the charger unit from its power source Failure to do so could result in personal injury or equipment damage SHOCK HAZARD Do not expose the unit to excessive moisture that would allow for liquid...

Страница 30: ...DRAFT 18 May 2005 Page 3 6 Jaundice Meter Model JM 103 User Manual usr070 NOTES...

Страница 31: ...the Jaundice Meter is left uncharged for a long period of time the power of the battery diminishes ensure that it is charged prior to use To charge the Jaundice Meter perform the following WARNING Th...

Страница 32: ...the charger unit so that its display faces you When the Jaundice Meter is set on the charger unit properly the Charger lamp lights up NOTE With a fully charged battery approximately 400 measurements c...

Страница 33: ...e Reset button allow approximately 15 seconds for the unit of measurement to switch from mg dL to mol L or vice versa 3 Visually ensure that the unit s display has changed 4 Release the Reset button w...

Страница 34: ...the instrument maintains consistent performance over time and that the operators are using the instrument properly Using the checker supplied with the charger unit check the instrument to verify that...

Страница 35: ...t perpendicular and take the measurement again NOTE The display interchanges between the L value the measured value of the long optical path and the S value the measured value of the short optical pat...

Страница 36: ...b Place the measuring probe perpendicular to the checker and push down gently until a click sounds c If the measured value still exceeds 1 0 of the reference value contact the nearest authorized serv...

Страница 37: ...Jaundice Meter on page 4 4 Proper light output is one factor that affects meter performance Light output must be within the range shown on the inside cover of the checker to obtain reliable measuremen...

Страница 38: ...nt for Bilirubin concentration as stated in the indications for use 4 Visually check that the Ready lamp illuminates 5 If the battery indicator blinks charge the battery see Charging the Battery on pa...

Страница 39: ...lue is outside the measurement range of 20 mg dL or 340 mol L the display shows and user should contact the physician NOTE If the instrument is not operated for more than 60 seconds the backlight on t...

Страница 40: ...If the caregiver has any concerns regarding the values being presented by the JM 103 for Bilirubin concentration the physician should be notified immediately for a determination as to whether support...

Страница 41: ...nstrument for measurement n 1 n 2 and so on up to n 5 will appear 2 Press the Reset button for 5 s The number of average measurements will switch as follows 3 Release the Reset button when the require...

Страница 42: ...he total number of measurements selected in this example 5 measurements WARNING This instrument emits intense light to take its measurements Take measurements only at the forehead or sternum hospital...

Страница 43: ...completed the average of the measured values appears in the display If the instrument is left without the preset number of measurements taken the setting will be canceled without the measurement valu...

Страница 44: ...DRAFT 20 June 2005 Page 5 8 Jaundice Meter Model JM 103 User Manual usr070 NOTES...

Страница 45: ...harsh cleansers detergents such as scouring pads and heavy duty grease removers or solvents such as toluene xylene and acetone Equipment damage could occur If there is no visible soilage with possibl...

Страница 46: ...rotection Agency Dilute the disinfectant according to the manufacturer s instructions Maintenance There are no user serviceable parts and no maintenance or calibration required Service is only require...

Страница 47: ...do not store near operating rooms Do not subject the instrument to severe vibration or impact Do not store the instrument in locations where chemicals are stored or where solvent gases may be emitted...

Страница 48: ...DRAFT 18 May 2005 Page 6 4 Jaundice Meter Model JM 103 User Manual usr070 NOTES...

Страница 49: ...ssages Warning Cause Solution Er1 The measured value is abnormal In the case of an averaging measurement the measurement fluctuation is excessively large Place the measuring probe perpendicular to the...

Страница 50: ...ank when the Power switch is in the On position The batteries are exhausted Charge the battery see Charging the Battery on page 4 1 The display suddenly goes blank during a measurement The batteries a...

Страница 51: ...lirubin The JM 103 reports values over a range of 0 20 mg dL estimated bilirubin Appendix A pages A2 A18 illustrate results of hospital site studies Appendix B pages B3 B8 illustrate results of physic...

Страница 52: ...ts were averaged The second study took one measurement only Estimated bilirubin measurements taken during the studies ranged from 1 1 to 20 8 mg dL In the doctor s office setting no measurement averag...

Страница 53: ...ce setting a study of 201 infants was performed Results showed similar performance at doctors offices as shown in Appendix B The data for the doctor s office setting contained no forehead measurements...

Страница 54: ...DRAFT 20 June 2005 Page A 4 Jaundice Meter JM 103 User Manual usr070 Graph 2 ospital Study Site A All Patients Sternum Graph 3 Hospital Study Site A African American Patients Forehead...

Страница 55: ...DRAFT 20 June 2005 Jaundice Meter JM 103 User Manual usr070 Page A 5 Graph 4 Hospital Study Site A African American Patients Sternum Graph 5 Hospital Study Site A Caucasian Patients Forehead...

Страница 56: ...DRAFT 20 June 2005 Page A 6 Jaundice Meter JM 103 User Manual usr070 Graph 6 Hospital Study Site A Causasian Patients Sternum Graph 7 Hospital Study Site A Other Patients Forehead...

Страница 57: ...DRAFT 20 June 2005 Jaundice Meter JM 103 User Manual usr070 Page A 7 Graph 8 Hospital Study Site A Other Patients Sternum Graph 9 Hospital Study Site B All Patients Forehead...

Страница 58: ...DRAFT 20 June 2005 Page A 8 Jaundice Meter JM 103 User Manual usr070 Graph 10 Hospital Study Site B All Patients Sternum Graph 11 Hospital Study Site B African American Patients Forehead...

Страница 59: ...DRAFT 20 June 2005 Jaundice Meter JM 103 User Manual usr070 Page A 9 Graph 12 Hospital Study Site B African American Patients Sternum Graph 13 Hospital Study Site B Caucasian Patients Forehead...

Страница 60: ...DRAFT 20 June 2005 Page A 10 Jaundice Meter JM 103 User Manual usr070 Graph 14 Hospital Study Site B Causasian Patients Sternum Graph 15 Hospital Study Site B Other Patients Forehead...

Страница 61: ...DRAFT 20 June 2005 Jaundice Meter JM 103 User Manual usr070 Page A 11 Graph 16 Hospital Study Site B Other Patients Sternum...

Страница 62: ...African American n 65 1 11 0 4 0 908 1 55 SITE A Forehead Cau casian n 399 1 01 0 1 0 916 1 2 SITE A Sternum Cauca sian n 399 1 04 0 6 0 956 0 88 SITE A Forehead Other n 49 1 06 0 5 0 941 1 04 SITE A...

Страница 63: ...DRAFT 20 June 2005 Jaundice Meter JM 103 User Manual usr070 Page A 13 Graph 17 Hospital Study Site A Error Plot Forehead Graph 18 Hospital Study Site A Error Plot Sternum...

Страница 64: ...DRAFT 20 June 2005 Page A 14 Jaundice Meter JM 103 User Manual usr070 Graph 19 Hospital Study Site B Error Plot Forehead Graph 20 Hospital Study Site B Error Plot Sternum...

Страница 65: ...ph 21 Infant Weight Distribution Graph 22 Hospital Study Site A Birthweight Error Plot Forehead Infant Weight grams Hospital Study A Hospital Study B Up to 999 6 2 1000 1499 15 0 1500 1999 23 13 2000...

Страница 66: ...asure the returning light The results of the device testing using the checker show that the device produced output within the required range over the course of both hospital studies Reproducibility te...

Страница 67: ...um bilirubin measurements This data supports the use of this non invasive device along with other clinical indicators as an aid in the management of jaundice in the neonatal patient population Table 2...

Страница 68: ...DRAFT 20 June 2005 Page A 18 Jaundice Meter JM 103 User Manual usr070 NOTES...

Страница 69: ...ed from approximately 24 hours to 7 10 days with a mean of 3 days at site 1 and 5 days at site 2 The test was performed on infants who were determined by their physician to require a serum bilirubin t...

Страница 70: ...ed 201 patients Measurement Selection Estimated bilirubin measurements taken during the studies ranged from 2 3 to 19 5 mg dL No Averaging of Readings was used with the JM 103 Body Sites Tested All in...

Страница 71: ...fice study and the difference in individual development Therefore please be aware that results at Doctors offices may differ from results at hospitals and may have more variability The reported data s...

Страница 72: ...DRAFT 20 June 2005 Page B 4 Jaundice Meter JM 103 User Manual usr070 Graph 1 Infant Age Doctors Office 1 Graph 2 Infant Age Doctors Office 2...

Страница 73: ...ice No 1 5 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Serum Bilirubin TSB mg dl JM 103 Reading TcB Mg dl Regression Line Upper Limit Lower Limit Data Points Regression Analysis Statistics Sample Size n 133...

Страница 74: ...Analysis Doctor s Office No 2 5 0 5 10 15 20 25 0 5 10 15 20 25 30 Serum Bilirubin TSB mg dl JM 103 Reading TcB Mg dl Regression Line Upper Limit Lower Limit Data Points Regression Analysis Statistic...

Страница 75: ...n Analysis Doctor s office setting 2 locations 5 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Serum Bilirubin TSB mg dl JM 103 Measurement Mg dl Regression Line Upper Limit Lower Limit Data Points Regression...

Страница 76: ...presented shows is that the JM 103 estimated bilirubin concentration measurement correlates to the serum bilirubin measurements This data supports the use of this non invasive device along with other...

Страница 77: ...Nov 3 Amato M Transcutaneous capillary and arterial bilirubin levels J Pediatr 125 2 332 1994 4 Amit Y et al Effect of skinfold thickness on transcutaneous bilirubin measure ments Biol Neonate 1993 5...

Страница 78: ...meter reliability J Perinatol 1990 Jun 13 Brown LP et al Transcutaneous bilirubinometer an instrument for clinical research Nurs Res 1990 Jul Aug 14 Brown LP et al Incidence and pattern of jaundice in...

Страница 79: ...r Kindergeneeskd 1984 Oct 23 Dominguez Ortega F et al Transcutaneous bilirubinometry correlation of the reading site obtained with spectrophotometry and diazoreaction technique An Esp Pediatr 1993 Nov...

Страница 80: ...nts Hum Biol 1994 Jun 32 Hanneman R et al Determination of serum bilirubin by skin reflectance effect of pig mentation Pediatr Res 13 12 1326 1329 Dec 1979 33 Hanneman R et al Evaluation of the Minolt...

Страница 81: ...ov 42 Hung WT et al Diagnosis of atretic prolonged obstructive jaundice technetium 99m hepatolite excretion study J Pediatr Surg 1990 Jul 43 Karrar Z et al Transcutaneous bilirubin measurements in Sau...

Страница 82: ...in mature newborns Acta Obstet Gynecol Scand 1989 68 719 24 52 Knudsen A The cephalocaudal progression of jaundice in newborns in relation to the transfer of bilirubin from plasma to skin Early Human...

Страница 83: ...try in neonatal intensive care units Arch Dis Child Fetal Neonatal Ed 1996 Jul 61 Kumar A Micro invasive management of neonatal bilirubinemia Indian Pediatr 1992 Sep 62 Kumar A et al Transcutaneous bi...

Страница 84: ...Pediatrics 99 4 599 601 Apr 1997 71 Moscicka A et al Usefulness of transcutaneous measurements of bilirubin in infants with jaundice Ginekol Pol 1994 Jun 72 Myara A et al Early changes in cutaneous bi...

Страница 85: ...m Dig 1991 Jan 81 Schubiger G et al Transcutaneous determination of bilirubin in the neonatal depart ment an analysis of its uses Helv Paediatr Acta 1986 Aug 82 Schumacher RE et al Transcutaneous bili...

Страница 86: ...91 Tan KL Transcutaneous bilirubinometry in Chinese and Malay neonates Ann Acad Med Singapore 1985 Oct 92 Tan KL et al Transcutaneous bilirubinometry in preterm very low birthweight infants Acta Paed...

Страница 87: ...w 1995 Oct 30 Nov 2 100 Vaisman S et al Clinical trial of a transcutaneous bilirubinometer Rev Chil Pediatr 1983 Mar Apr 101 Veleminsky M The significance of transcutaneous measurement of bilirubin in...

Страница 88: ...hototherapy Biol Neonate 1989 110 Yamauchi Y et al Transcutaneous bilirubinometry serum bilirubin measurement using transcutaneous bilirubinometer TcB A preliminary study Biol Neonate 1989 111 Yamauch...

Страница 89: ...3 User Manual usr070 Page C 13 116 Yamauchi Y et al Factors affecting transcutaneous bilirubin measurement effect of daylight Acta Paediatr Jpn 1991 Oct 117 Yip WC et al Transcutaneous bilirubinometry...

Страница 90: ...DRAFT 9 Nov 2004 Page C 14 Jaundice Meter JM 103 User Manual usr070 NOTES...

Страница 91: ...PROPRIETARY AND CONFIDENTIAL DRAFT 5 14 04...

Страница 92: ...hird parties without the prior written consent of Draeger Medical Systems Inc 2006 by Draeger Medical Systems Inc ALL RIGHTS RESERVED Manufactured by Distributed by EC Representative Konica Minolta Se...

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