Dräger JM-103 Instructions Manual
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Dräger JM-103 Instructions Manual

Jaundice meter
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Instructions for Use
Dräger Jaundice Meter
WARNING
To properly use this medical
device, the user must obtain a
full understanding of the per-
formance characteristics of
this medical device prior to
use by carefully reading these
Instructions for Use.
Model JM-103

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Summary of Contents for Dräger JM-103

  • Page 1 Instructions for Use Dräger Jaundice Meter WARNING Model JM-103 To properly use this medical device, the user must obtain a full understanding of the per- formance characteristics of this medical device prior to use by carefully reading these Instructions for Use.

  • Page 3: Table Of Contents

    PROPRIETARY AND CONFIDENTIAL DRAFT 9 Nov 04 Table of Contents Section 1: Symbol Definition and Intended Use Symbol Definition ........1 - 1 Intended Use .
  • Page 4 Setting the Number of Average Measurements ..5 - 5 Taking Average Measurements ..... 5 - 6 Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning .

  • Page 5: Section 1: Symbol Definition And Intended Use

    DRAFT 18 May 2005 Section 1 Symbol Definition and Intended Use Symbol Definition This manual contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • Standard text—used for regular information. •...
  • Page 6 DRAFT 18 May 2005 • The symbol below highlights a type BF applied part: Type BF Applied Part – The instrument provides a specified degree of protection against electric shock, particularly the leakage current and reliability of the protective ground connection with an F-type applied part.
  • Page 7 DRAFT 18 May 2005 • The symbol below, when applied to the device, indicates: ATTENTION: Consult Accompanying Documents • The symbol below, when applied to the device, indicates: ATTENTION: Consult Instructions for Use • The symbol below, when applied to the device, indicates: Do Not Throw Away Jaundice Meter Instructions for Use (MU01380) Page 1 - 3...

  • Page 8: Intended Use

    DRAFT 18 May 2005 Intended Use WARNING: Magnetic Resonance Imaging (MRI) procedures interfere with Jaundice Meter operation. Inaccurate readings could occur. WARNING: Do not use a mobile telephone when using the Jaundice Meter. A measurement error could occur. Intended Use of the Jaundice Meter The Jaundice Meter is a non-invasive transcutaneous bilirubinometer.
  • Page 9 DRAFT 18 May 2005 Precocious Jaundice Do not use this device on infants with precocious jaundice. If there is a possibility that the infant is suffering from precocious jaundice, as a result of an incompatible blood type or hemolytic jaundice, it is recommended that the total serum bilirubin be measured.
  • Page 10 DRAFT 18 May 2005 Page intentionally left blank. Page 1 - 6 Jaundice Meter Instructions for Use (MU01380)

  • Page 11: Section 2: Introduction, Features, And Specifications

    DRAFT 20 June 2005 Section 2 Introduction, Features, and Specifications Introduction To prevent kernicterus in newborn infants, it is very important to detect jaundice in its early stages. The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. This hand-held device allows a quick, non-invasive estimate of bilirubin concentration, to be used as an aid for the management of jaundice in newborn infants.

  • Page 12: Explanation Of The Test

    DRAFT 20 June 2005 Phototherapy WARNING: Do not use the Jaundice Meter after initiation of phototherapy or after an exchange transfusion. Results may be inaccurate under these conditions. Explanation of the Test Measuring Principle The Jaundice Meter determines the yellowness of an infant’s subcutaneous tissue by measuring the difference in the optical densities for light in the blue (450 nm) and green (550 nm) wavelength regions.
  • Page 13 DRAFT 20 June 2005 subcutaneous tissue passes through the inner core, or short-optical path, of the fiber. The part scattered from the deep areas of the subcutaneous tissue passes through the outer core, or long-optical path, and then reaches its corresponding photodiode. By calculating the difference in the optical densities, the parts that are common to the epidermis and dermis are deducted, and as a result, the difference in the optical densities between the two wavelength regions...
  • Page 14 Calibration The JM-103 does not require user calibration. The system includes a checker that measures the intensity of light from the device to ensure the light output is acceptable for proper use. Light intensity must be checked daily.
  • Page 15 DRAFT 20 June 2005 Processing of Measured Values The Jaundice Meter determines the yellowness of the subcutaneous tissue by measuring the difference in the optical densities for light in the blue and green wavelength regions. The optical density difference has been shown to have a linear correlation with serum bilirubin concentration.

  • Page 16: Features

    DRAFT 20 June 2005 Features Controls, Indicators, and Connections Controls, Indicators, and Connections Name 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.
  • Page 17 DRAFT 20 June 2005 Name Function Ready lamp Illuminates to indicate that the Jaundice Meter is ready for the next measurement. Strap attachment area Is where the strap attaches. G Reset button Deletes the currently displayed measured value and prepares for the next measurement. When used with the Power switch, the device switches to Check Mode and changes the unit of measurement.

  • Page 18: Display

    DRAFT 20 June 2005 Display Name Function A AVG Illuminates during averaging measurement. B Optical path indicator When verifying light output with the checker, (•) (•)illuminates when the L-value appears and extinguishes when the S-value appears. C Value Displays the measured value. NOTE: When the measured value is greater than 20 mg/dl or 340 μmol/L, the display shows “---”...

  • Page 19: Standard Features

    DRAFT 20 June 2005 Standard Features • Jaundice Meter (JM-103) • Charger unit (Model JM-A30) with a checker • AC adapter (Model JM-A32) • Carrying case and wrist strap • Power cable adapter set Jaundice Meter Instructions for Use (MU01380)

  • Page 20: Specifications

    DRAFT 20 June 2005 Specifications Standard Features Feature Dimension Model name JM-103 Measuring method Determines the yellowness of the subcutaneous tissue by using two optical paths to measure the optical density difference at two wave- lengths 0.0 mg/dL to 20 mg/dL or 0 μmol/L Measurement range to 340 μmol/L...

  • Page 21: Regulations, Standards, And Codes

    DRAFT 20 June 2005 available and can be affected by variables such as infant developmental age, ethnicity, etc. Therefore, we recommend that the JM-103 be used in conjunction with other clinical signs and laboratory measurements. "Specific Bilirubin Measurement" should be confirmed by other methods such as laboratory blood serum analysis.

  • Page 22: Electromagnetic Compatibility (Emc) Guidance And Manufacturer's Declarations

    DRAFT 20 June 2005 Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declarations Guidance and Manufacturer’s Declaration—Electromagnetic Emissions The Jaundice Meter is intended for use in the electromagnetic envi- ronments specified below. The customer or user of the unit should ensure that the unit is used in such environments. Electromagnetic Emissions Test Compliance...
  • Page 23 DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter is intended for use in the electromagnetic envi- ronments specified below. The customer or user of the unit should ensure that the unit is used in such environments. Electromagnetic Immunity IEC 60601...
  • Page 24 DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter is intended for use in the electromagnetic envi- ronments specified below. The customer or user of the unit should ensure that the unit is used in such environments. Electromagnetic Immunity IEC 60601...
  • Page 25 DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter is intended for use in the electromagnetic environ- ments specified below. The customer or user of the unit should ensure that the unit is used in such environments. Compli Electromagnetic Environment—...
  • Page 26 DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter is intended for use in the electromagnetic environ- ments specified below. The customer or user of the unit should ensure that the unit is used in such environments. Compli Electromagnetic Environment—...

  • Page 27: Section 3: Precautions And Safety Tips

    DRAFT 18 May 2005 Section 3 Precautions and Safety Tips Precautions WARNING: Do not use the instrument in areas where flammable or combustible gases, such as anesthetic gases, are present. Doing so could result in a fire. Personal injury or equipment damage could occur.
  • Page 28 DRAFT 18 May 2005 CAUTION: Do not use the instrument in direct sunlight. Equipment damage could occur. CAUTION: The Jaundice Meter is a precision instrument. When using it, do not drop it, expose it to shocks or strong vibrations, or place heavy objects on it.

  • Page 29: Electromagnetic Compatibility Precautions

    DRAFT 18 May 2005 Electromagnetic Compatibility Precautions General information on electromagnetic compatibility (EMC) according to the international EMC standard IEC 60601-1- 2: 2001 Pins of connectors identified with the ESD warning symbol shall not be touched and not be connected unless ESD precautionary procedures are used.

  • Page 30: Safety Tips

    WARNING: The charger unit (JM-A30) and the AC adapter (JM-A32) are solely designed for use with the Jaundice Meter (JM-103). Use them only when charging the instrument. Using them to charge other equipment could result in personal injury or equipment damage.

  • Page 31: Warning And Caution Labels

    DRAFT 18 May 2005 SHOCK HAZARD: Do not plug or unplug the AC power cord’s plug with wet hands. Personal injury or equipment damage could occur. SHOCK HAZARD: Before cleaning, maintenance, or parts replacement, unplug the charger unit from its power source. Failure to do so could result in personal injury or equipment damage.
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  • Page 33: Section 4: Installation And Assembly

    DRAFT 20 June 2005 Section 4 Installation and Assembly Installation Before using the instrument, charge and inspect the instrument. Charging the Battery When using the instrument for the first time, ensure that it is fully charged. To maintain a full charge at all times, place the instrument on the charger unit when it is not being used for measurements.
  • Page 34 DRAFT 20 June 2005 CAUTION: Unit must be placed in charger as shown, or damage to charging contacts could occur. Place the Jaundice Meter on 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.

  • Page 35: Selecting The Unit Of Measurement

    DRAFT 20 June 2005 Selecting the Unit of Measurement Hold down the Reset button, and turn on the Power switch. Do not release the Reset button. While continuing to press the Reset button, allow approximately 15 seconds for the unit of measurement to switch from mg/dL to μmol/L, or vice versa.

  • Page 36: Operational Checkout Of The Jaundice Meter

    If the checker gets dirty, wipe it with a soft cloth dampened with alcohol, and then wipe it with a dry cloth. Although the JM-103 device can be damaged as stated on pages 3-1 and 3-4, we recommend the unit always be verified to be operating properly by following the steps as stated in sections 4 and 5.
  • Page 37 DRAFT 20 June 2005 Open the cover of the checker. Use only the checker supplied with the Jaundice Meter. Place the measuring probe perpendicular to the checker, and push down gently until the unit clicks. If the measuring probe contacts the checker at an angle, place it perpendicular, and take the measurement again.
  • Page 38 DRAFT 20 June 2005 Clean both the checker and the measuring probe. Place the measuring probe perpendicular to the checker, and push down gently until a click sounds. If the measured value still exceeds ± 1.0 of the reference value, contact the nearest authorized service facility, and take the unit out of service.

  • Page 39: Section 5: Instructions For Use

    Instructions for Use Instructions for Use WARNING: The JM-103 is a screening device for bilirubin in the tissues and is not intended to be used as a stand-alone measurement. When Jaundice Meter results meet or exceed action levels established by the unit, department, or facility, or are excessive for the newborn's age in hours, the user should follow the procedures established by the user's facility.
  • Page 40 DRAFT 20 June 2005 WARNING: Before use, clean the measuring probe by wiping it with an alcohol swab. Failure to do so could result in the spread of infection or infant injury. Using medicinal alcohol and a soft cloth, clean the measuring probe. Set the Power switch to the On position.
  • Page 41 DRAFT 20 June 2005 WARNING: Do not press the measuring probe when it is directed toward the infant’s or caregiver’s eyes. Damage to the eyes could occur. WARNING: Take measurements only on the infant’s sternum (at hospital sites or physicians’ offices) or forehead (at hospital sites only). Inaccurate readings could occur.
  • Page 42 DRAFT 20 June 2005 If the measured value is outside the measurement range of 20 mg/dL or 340 μmol/L, the display shows “---” and the user should contact the physician. NOTE: If the instrument is inactive for more than 60 seconds, the backlight on the display goes out.

  • Page 43: Setting The Number Of Average Measurements

    DRAFT 20 June 2005 Setting the Number of Average Measurements Set the Power switch to On or press the Reset button to prepare the instrument for measurement. • n-1, n-2, and so on (up to n-5) will appear. Press the Reset button for 5 seconds. The number of average measurements will switch as follows: Release the Reset button when the required number of average measurements is displayed.

  • Page 44: Taking Average Measurements

    DRAFT 20 June 2005 Taking Average Measurements Set the number of average measurements needed. Ensure that the Ready lamp is illuminated once n-5 appears. NOTE: n-5 is used in the steps below as an example. The number of measurements you require and set is the number that should appear in the display.
  • Page 45 DRAFT 20 June 2005 While ensuring that the Ready lamp is illuminated, repeat the measuring until the number of remaining measurements is 0. • When the remaining number of measurements is completed, the average of the measured values appears in the display. •...
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  • Page 47: Section 6: Cleaning, Maintenance, Replacement Parts, And Storage And Handling

    DRAFT 18 May 2005 Section 6 Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning SHOCK HAZARD: Before cleaning, maintenance, or parts replacement, 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 pooling.

  • Page 48: Disinfecting

    DRAFT 18 May 2005 Disinfecting When there is visible soilage, and between patients, disinfect the unit with alcohol. Maintenance WARNING: Only qualified service personnel should perform preventive maintenance on the Jaundice Meter. Preventive maintenance performed by unauthorized personnel could result in personal injury or equipment damage.

  • Page 49: Replacement Parts

    Jaundice Meter, refer to Table 1 on page 6-3. Parts other than those shown should be replaced only by qualified service personnel. Table 1: Replacement Parts Part Number Description MU20506 Dräger Jaundice Meter, model JM-103 MU00831 Battery MU01704 Soft case MU01705 Carrying strap...

  • Page 50: Storage And Handling

    DRAFT 18 May 2005 Part Number Description 1851691 Cable, CH, 3 m, SN SEV 1011 1851705 Cable, AU, 3 m, AS 3112 1851713 Cable, GB, 3 m, BS 1363 1868160 Cable, 3 m, N 5-15P 250 V 1868950 Cable, DK, 3 m Storage and Handling When storing the instrument, pay attention to the following conditions: •...

  • Page 51: Disposal

    DRAFT 18 May 2005 Disposal This device is subject to EU Directive 2002/96/EC (WEEE). It is not registered for use in private households, and may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger Medical has authorized a firm to dispose of this device in the proper manner.
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  • Page 53: Section 7: Troubleshooting

    DRAFT 18 May 2005 Section 7 Troubleshooting Service Calls When calling technical support about your unit, be prepared to give the serial number from the product identification label. When giving the serial number, the technical support representative can identify your unit and provide the information you need more quickly.

  • Page 54: Troubleshooting

    DRAFT 18 May 2005 Troubleshooting WARNING: Only properly trained personnel should troubleshoot the Jaundice Meter. Troubleshooting by unauthorized personnel could result in personal injury or equipment damage. If an abnormality occurs with the Jaundice Meter, perform the following: Refer to the table below, and take the necessary action given. If the abnormality still appears, set the Power switch to the Off position, and then return it to the On position.
  • Page 55 DRAFT 18 May 2005 Troubleshooting Symptom Possible Cause Action The display is blank The batteries are Charge the battery (see when the Power switch exhausted. “Charging the Battery” is in the On position. on page 4-1). The display suddenly The batteries are Charge the battery (see goes blank during a exhausted.
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  • Page 57: Appendix A: Clinical Performance Summary

    The data in the following sections is provided to demonstrate results of the JM-103 clinical studies, in comparison to total serum bilirubin. The JM-103 reports values over a range of 0-20 mg/dL estimated bilirubin.
  • Page 58 All patients meeting the above criteria were included in the study. There was significant effort to ensure sufficient representation of all skin pigmentation to verify that the JM-103 could be used across all populations with consistent results. The demographics of the patient population included Caucasian, African-American, East-Asian, Indian- Pakistani, and Hispanic infants.

  • Page 59: Performance Data

    Jaundice Meter. This series of graphs shows the correlation of the estimated bilirubin concentration taken non-invasively with the JM-103 to the actual serum bilirubin concentration measured from a blood sample taken from the patient (TSB) as explained in Sections 4 and 5. The device operates over a range of 0.0 –...
  • Page 60 DRAFT 20 June 2005 Graph 2 – Hospital Study Site A All Patients, Sternum Graph 3 – Hospital Study Site A African-American Patients, Forehead Page A - 4 Jaundice Meter Instructions for Use (MU01380)
  • Page 61 DRAFT 20 June 2005 Graph 4 – Hospital Study Site A African-American Patients, Sternum Graph 5 – Hospital Study Site A Caucasian Patients, Forehead Jaundice Meter Instructions for Use (MU01380) Page A - 5...
  • Page 62 DRAFT 20 June 2005 Graph 6 – Hospital Study Site A Caucasian Patients, Sternum Graph 7 – Hospital Study Site A Other Patients, Forehead Page A - 6 Jaundice Meter Instructions for Use (MU01380)
  • Page 63 DRAFT 20 June 2005 Graph 8 – Hospital Study Site A Other Patients, Sternum Graph 9 – Hospital Study Site B All Patients, Forehead Jaundice Meter Instructions for Use (MU01380) Page A - 7...
  • Page 64 DRAFT 20 June 2005 Graph 10 – Hospital Study Site B All Patients, Sternum Graph 11– Hospital Study Site B African-American Patients, Forehead Page A - 8 Jaundice Meter Instructions for Use (MU01380)
  • Page 65 DRAFT 20 June 2005 Graph 12 – Hospital Study Site B African-American Patients, Sternum Graph 13 – Hospital Study Site B Caucasian Patients, Forehead Jaundice Meter Instructions for Use (MU01380) Page A - 9...
  • Page 66 DRAFT 20 June 2005 Graph 14 – Hospital Study Site B Causasian Patients, Sternum Graph 15 – Hospital Study Site B Other Patients, Forehead Page A - 10 Jaundice Meter Instructions for Use (MU01380)
  • Page 67 DRAFT 20 June 2005 Graph 16 – Hospital Study Site B Other Patients, Sternum Jaundice Meter Instructions for Use (MU01380) Page A - 11...
  • Page 68 DRAFT 20 June 2005 Table 1: Summary Table of Slope, Intercept, Standard Deviation, and Correlation Coefficients for Each Graph Correlation Standard Study Site / Patient Slope Intercept Coefficient Deviation Population (RMSE) SITE A Forehead All 1.05 -0.35 0.914 1.29 (n=513) SITE A Sternum All 1.07 -0.74...
  • Page 69 DRAFT 20 June 2005 Graph 17 – Hospital Study Site A Error Plot, Forehead Graph 18 – Hospital Study Site A Error Plot, Sternum Jaundice Meter Instructions for Use (MU01380) Page A - 13...
  • Page 70 DRAFT 20 June 2005 Graph 19 – Hospital Study Site B Error Plot, Forehead Graph 20 – Hospital Study Site B Error Plot, Sternum Page A - 14 Jaundice Meter Instructions for Use (MU01380)
  • Page 71 DRAFT 20 June 2005 Graph 21 – Infant Weight Distribution Infant Weight Hospital Study A Hospital Study B (grams) Up to 999 1000 - 1499 1500 - 1999 2000 - 2499 2500 - 2999 3000 - and up Unknown Total Graph 22 –...
  • Page 72 DRAFT 20 June 2005 Graph 23 – Hospital Study Site A Birthweight Error Plot, Sternum Reproducibility Reproducibility of the light output of the device was tested daily using the checker. The checker determines the intensity of the light output of the device.

  • Page 73: Conclusion

    DRAFT 20 June 2005 Table 2: Reproducibility Data Mean Estimated Bilirubin Deviation Deviation Deviation Body Site Measure Range Mean Median ment Range (mg/dL) Sternum 0.0 - 2.2 0.8 - 18.5 Forehead 0.0 - 2.6 0.1 - 19.5 Conclusion The data shows that the estimated bilirubin concentration measurement from the Jaundice Meter correlates to the serum bilirubin measurements.
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  • Page 75: Appendix B Doctors' Office Data

    DRAFT 20 June 2005 Appendix B Doctors’ Office Data Study Design Studies were performed at two doctors’ office sites comparing JM-103 Total Calculated Bilirubin (TcB) to laboratory measured total serum bilirubin (TSB). Selection Criteria The ages of the infants in the study ranged from approximately 24 hours to 7-10 days, with a mean of 3 days (at site 1) and 5 days (at site 2).
  • Page 76 DRAFT 20 June 2005 The doctor's office study was composed of the following ethnic groups: TcB Range ≤ ≥ Caucasian 2.3-19.5 72 hrs & 70 72hrs ≤ ≥ African- 4.9-17.3 72 hrs & 7 72hrs American ≤ ≥ Mid-Eastern 8.8 - 16.0 72 hrs &...

  • Page 77: Performance Data

    JM-103 reports values over a range of 0-20 mg/dL estimated bilirubin. Although the doctor's office study showed correlation of JM-103 to the TSB laboratory values, the relationship (bias) of the JM-103 to the TSB values was somewhat different than previously reported for hospital sites (as previously shown in Appendix A).
  • Page 78 DRAFT 20 June 2005 Graph 1 – Infant Age, Doctor’s Office #1 Graph 2 – Infant Age, Doctor’s Office #2 Page B - 4 Jaundice Meter Instructions for Use (MU01380)
  • Page 79 DRAFT 20 June 2005 Graph 3 – Regression Analysis, Doctors’ Office #1 JM-103 Regression Analysis Doctor's office No.1 Serum Bilirubin TSB (mg/dl) Regression Line Upper Limit Low er Limit Data Points Regression Analysis Statistics Sample Size (n) = 133. Y = -0.636 + 0.977 X Root Mean Square Error (MSE) = 1.572...
  • Page 80 DRAFT 20 June 2005 Graph 4 – Regression Analysis, Doctors’ Office #2 JM-103 Regression Analysis Doctor's Office No.2 Serum Bilirubin TSB (mg/dl) 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...
  • Page 81 DRAFT 20 June 2005 Graph 5 – Regression Analysis, Doctors’ Office Setting, 2 Locations JM-103 Regression Analysis Doctor's office setting - 2 locations Serum Bilirubin TSB (mg/dl) Regression Line Upper Limit Low er Limit Data Points Regression Analysis Statistics Sample Size = 201 Y = 0.233 +0.934 X...

  • Page 82: Conclusion

    DRAFT 20 June 2005 Conclusion The data show that the Jaundice Meter estimated bilirubin concentration measurement correlates to the serum 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.

  • Page 83: Appendix C: Medical And Scientific References On Transcutaneous Bilirubinometry

    DRAFT 9 Nov 2004 Appendix C Medical and Scientific References on Transcutaneous Bilirubinometry Amato M, Pasquier S, de Muralt G. Transcutaneous bilirubin deter- mination: correlation in white premature infants weighing less than 1500 gm [in French]. Schweiz Med Wochenschr. 1985;115(27- 28):937-938.
  • Page 84 DRAFT 9 Nov 2004 Brown LP, Arnold L, Allison D, Jacobsen B, Klein ME, Charsha D. Transcutaneous bilirubinometer: intermeter reliability. J Perinatol. 1990;10(2):167-169. Brown L, Arnold L, Charsha D, Allison D, Klein ME. Transcutane- ous bilirubinometer: an instrument for clinical research. Nurs Res. 1990;39(4):241-243.
  • Page 85 DRAFT 9 Nov 2004 Douville P, Masson M, Forest JC. Diagnostic value of sequential readings with the Minolta transcutaneous bilirubinometer in normal and low-birthweight infants [letter]. Clin Chem. 1983;29(4):740- 741. Fabris C, Licata D, Roberi P, et al. Evaluation of transcutaneous bilirubinometry in newborn infants [in Italian].
  • Page 86 DRAFT 9 Nov 2004 Hegyi T. Transcutaneous bilirubinometry in the newborn infant: state of the art. J Clin Monit. 1986;2(1):53-59. Hegyi T, Graff M, Zapanta V, Hiatt IM, Sisson TR. Transcutaneous bilirubinometry. III. Dermal bilirubin kinetics under green and blue light phototherapy.
  • Page 87 DRAFT 9 Nov 2004 Knudsen A, Brodersen R. Skin colour and bilirubin in neonates. Arch Dis Child. 1989;64(4):605-609. Knudsen A, Lebech M. Maternal bilirubin, cord bilirubin, and pla- centa function at delivery and the development of jaundice in mature newborns. Acta Obstet Gynecol Scand. 1989;68(8):719-724. Knudsen A.
  • Page 88 DRAFT 9 Nov 2004 Lebrun F, Sender A, Goujard J, Francoual C, Amiel-Tison C. Clini- cal evaluation of transcutaneous bilirubinometry [in French]. Ann Pediatr (Paris). 1982;29(7):494-498. Lin YJ, Ju SH, Lin CH. The clinical application of transcutaneous bilirubinometry in full-term Chinese infants. Ahonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi.
  • Page 89 DRAFT 9 Nov 2004 Myara A, Sender A, Valette V, et al. Early changes in cutaneous bilirubin and serum bilirubin isomers during intensive phototherapy of jaundiced neonates with blue and green light. Biol Neonate. 1997;71(2):75-82. Onks D, Silverman L, Robertson A. Effect of melanin, oxyhemo- globin and bilirubin on transcutaneous bilirubinometry.
  • Page 90 DRAFT 9 Nov 2004 Serrao PA, Modanlou HD. Significance of anti-A and anti-B isohe- magglutinins in cord blood of ABO incompatible newborn infants: correlation with hyperbilirubinemia. J Perinatol. 1989;9(2):154- 158. Sharma JN, Singh RN, Lodha A, Singh J. Transcutaneous bilirubi- nometry in newborns.
  • Page 91 DRAFT 9 Nov 2004 102. Uchida K, Kaneoka T, Ichihara J, Shirakawa K. Fundamental stud- ies on transcutaneous bilirubinometry in newborn infants using an organ scanning spectrophotometer [in Japanese]. Nippon Sanka Fujinka Gakkai Zasshi. 1988;40(2):167-173. 103. Utchajkin VF, Baranova EB, Ovanesov EN, Setsko IV. Clinical importance of noninvasive bilirubinemia monitoring by children viral hepatitis.
  • Page 92 DRAFT 9 Nov 2004 114. Yamauchi Y, Yamanouchi I. Transcutaneous bilirubinometry: serum bilirubin measurement using transcutaneous bilirubinometer (TcB). A preliminary study. Biol Neonate. 1989;56(5):257-262. 115. Yamauchi Y, Yamanouchi I. Transcutaneous bilirubinometry in nor- mal Japanese infants. Acta Paediatr Jpn. 1989;31(1):65-72. 116.
  • Page 94 These Instructions for Use only apply to Jaundice Meter Model JM-103 International with the Serial No.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for gen- eral information only and are not intended for use with any specific machine or device.

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