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Dräger Medical JM-103, Operating Instructions Manual

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WARNING:

For a 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/Dräger Medical

Summary of Contents for JM-103

Page 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...

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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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