Page 1
Jaundice Meter Konica Minolta/Dräger Medical WARNING: Model JM-103 For a full understanding of the Operating Instructions performance characteristics of this equipment, the user should carefully read this manual before operating.
Taking Measurements ......5 - 1 Jaundice Meter (Model JM-103) User Manual (usr070)
Page 4
Conclusion ........B - 8 Appendix C: Medical and Scientific References on Transcutaneous Bilirubinometry (1979 - 1997) Page ii Jaundice Meter (Model JM-103) User Manual (usr070)
1.1 times the highest-rated mains voltage is applied between the applied part and ground. Jaundice Meter (Model JM-103) User Manual (usr070) Page 1 - 1...
Page 6
• The symbol below indicates that the product uses a RECHARGEABLE BATTERY: Rechargeable Battery Symbol • The symbol below indicates RESET: RESET Button Symbol • The symbol below, when applied to the device, indicates: ATTENTION: Consult Accompanying Documents Page 1 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
The Jaundice Meter (JM-103) is not intended for home use. Limitations (Doctors’ Office Use) Use only on infants up to 14 days of age.
Page 8
Intended Use of the User Manual This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the Jaundice Meter (JM-103). Konica Minolta/Dräger Medical cannot be responsible for the performance of the Jaundice Meter if the user does not operate the unit in accordance with the instructions, fails to follow maintenance recommendations, or makes any repairs with unauthorized components.
Introduction To prevent kernicterus in newborn infants, it is very important to detect jaundice in its early stages. The Jaundice Meter (JM-103) 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.
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. Page 2 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
Page 11
Where L and S are the long and short optical path measurements. Use of the Device Patient Population The Jaundice Meter (JM-103) is indicated for use in neonatal patients born >35 weeks gestation who have not undergone transfusion or phototherapy treatment.
Page 12
Processing of Measured Values The Jaundice Meter (JM-103) 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.
Illuminates to indicate that the Jaundice Meter is ready for the next measurement. C Display Displays the measured value. D Measuring probe Takes the measurement when pressed against the measuring point. Jaundice Meter (Model JM-103) User Manual (usr070) Page 2 - 5...
Page 14
Check Mode. M Standard checker For reference. values N DC plug Connect the charger’s DC jack to this. O DC Plug (interna- Connect the charger’s DC jack to this. tional) Page 2 - 6 Jaundice Meter (Model JM-103) User Manual (usr070)
Go to “Charging the Battery” on page 4-1. If the power is on and the display is blank, the battery is completely exhausted. Go to “Charging the Battery” on page 4-1. Jaundice Meter (Model JM-103) User Manual (usr070) Page 2 - 7...
DRAFT 20 June 2005 Standard Features • Jaundice Meter (JM-103) • Charger unit (Model JM-A30) with a checker • AC adapter (Model JM-A31) • Carrying case and wrist strap Page 2 - 8 Jaundice Meter (Model JM-103) User Manual (usr070)
AC adapter input for 100V-240V, 50/60 Hz, 0.14-0.07A international use (new) AC adapter output 9V, 500 mA, 4.5W *The standard deviation shown above is based on the average of the Jaundice Meter (Model JM-103) User Manual (usr070) Page 2 - 9...
The SEE shown above are based on the clinical data 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.
Manufacturer’s Declarations Guidance and Manufacturer’s Declaration—Electromagnetic Emissions The Jaundice Meter (JM-103) is intended for use in the electromag- netic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment.
Page 20
DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter (JM-103) is intended for use in the electromag- netic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment.
Page 21
DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter (JM-103) is intended for use in the electromag- netic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment.
Page 22
DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter (JM-103) is intended for use in the electromag- netic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment.
Page 23
DRAFT 20 June 2005 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Jaundice Meter (JM-103) is intended for use in the electromag- netic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment.
Page 24
DRAFT 20 June 2005 NOTES: Page 2 - 16 Jaundice Meter (Model JM-103) User Manual (usr070)
AC adapter. Fire, personal injury, or equipment damage could occur. CAUTION: Do not place the instrument on an unstable or sloping surface. The instrument or charger unit could drop or overturn. Equipment damage could occur. Jaundice Meter (Model JM-103) User Manual (usr070) Page 3 - 1...
Page 26
The instrument has a built-in, non-user-replaceable battery. Do not disassemble the instrument to replace the battery. To replace the battery, contact your dealer or authorized service center. Failure to do so could result in equipment damage. Page 3 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the technical documentation available from Dräger Service upon request. Jaundice Meter (Model JM-103) User Manual (usr070) Page 3 - 3...
WARNING: The charger unit (JM-A30) and the AC adapter (JM-A31) 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.
Do not use harsh cleansers/detergents, such as scouring pads and heavy duty grease removers, or solvents, such as toluene, xylene, and acetone. Equipment damage could occur. Warning and Caution Labels Jaundice Meter (Model JM-103) User Manual (usr070) Page 3 - 5...
Page 30
DRAFT 18 May 2005 NOTES: Page 3 - 6 Jaundice Meter (Model JM-103) User Manual (usr070)
Use only the charger unit and AC adapter supplied with the Jaundice Meter. NOTE: The shape of the AC adapter varies according to region. NOTE: 120V model shown. Jaundice Meter (Model JM-103) User Manual (usr070) Page 4 - 1...
Page 32
Failure to do so could result in equipment damage. To replace the battery, contact your dealer or an authorized service facility. Page 4 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
The Ready lamp lights up, indicating that the instrument is ready to take a measurement. To change the unit of measurement once more, turn off the Power switch, and repeat step 1. Jaundice Meter (Model JM-103) User Manual (usr070) Page 4 - 3...
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 damamged 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 35
± 1.0 of the reference values indicated on the checker cover, the unit is acceptable for use. If the measured value exceeds ± 1.0 of the reference value, perform the following: Jaundice Meter (Model JM-103) User Manual (usr070) Page 4 - 5...
Page 36
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. Close the cover of the checker. 10. Set the Power switch to the Off position. Page 4 - 6 Jaundice Meter (Model JM-103) User Manual (usr070)
Before use, clean the measuring probe by wiping it with medicinal alcohol. Failure to do so could result in the spread of infection or infant injury. Using medicinal alcohol, clean the measuring probe. Jaundice Meter (Model JM-103) User Manual (usr070) Page 5 - 1...
Page 38
Bilirubin in the tissues and should never be used as a stand-alone measurement. Always contact the physician whenever the JM-103 measurements present a concern. The physician will make the determination regarding the laboratory blood serum TSB, as well as other clinical considerations, as these are appropriate measurement for Bilirubin concentration as stated in the indications for use.
Page 39
DRAFT 20 June 2005 NOTE: Only use the sternum location for JM-103 measurements when the device is used in a doctor’s office. Push the measuring probe gently until a click sounds. The instrument’s xenon lamp flashes momentarily, and the measured value appears on the display.
Page 40
JM 103 for Bilirubin concentration, the physician should be notified immediately for a determination as to whether supportive laboratory blood serum analysis is required or infant retest is appropriate. Page 5 - 4 Jaundice Meter (Model JM-103) User Manual (usr070)
• If n-2 through n-5 is selected, AVG appears in the upper left corner of the display. • The selected number of average measurements will be recorded. Jaundice Meter (Model JM-103) User Manual (usr070) Page 5 - 5...
Place the measuring probe vertically on the measuring point, and then apply gentle pressure until the probe clicks. • The measurement will be taken, and the number of remaining measurements will be displayed. Page 5 - 6 Jaundice Meter (Model JM-103) User Manual (usr070)
Page 43
Reset button and reset the number of average measurements needed. • To change the number of average measurements, refer to “Setting the Number of Average Measurements” on page 5-5. Jaundice Meter (Model JM-103) User Manual (usr070) Page 5 - 7...
Page 44
DRAFT 20 June 2005 NOTES: Page 5 - 8 Jaundice Meter (Model JM-103) User Manual (usr070)
Excessive moisture can damage mechanisms or electronics in this unit. Cleaning Difficult to Access Areas Do not attempt to disassemble the reader or base for cleaning. Wipe exterior surfaces only. To remove difficult spots or stains, we Jaundice Meter (Model JM-103) User Manual (usr070) Page 6 - 1...
Failure to do so could result in equipment damage. There are no user-replaceable parts. To replace the battery, contact your dealer or an authorized service facility. Page 6 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
Dräger Medical has authorized a firm to dispose of this device in the proper manner. For more detailed information, please contact your local Dräger Medical organization. (Alternatively: further information can be obtained from our national Dräger Medical organization.) Jaundice Meter (Model JM-103) User Manual (usr070) Page 6 - 3...
Page 48
DRAFT 18 May 2005 NOTES: Page 6 - 4 Jaundice Meter (Model JM-103) User Manual (usr070)
Off position, and then return aging measurement, or the it to the On position. If the hardware is not functioning warning still appears, contact properly. the nearest authorized service facility. Jaundice Meter (Model JM-103) User Manual (usr070) Page 7 - 1...
The Ready lamp is not Before taking a measurements. illuminated. measurement, ensure that the Ready lamp is illuminated. The batteries are Charge the battery (see exhausted. “Charging the Battery” on page 4-1). Page 7 - 2 Jaundice Meter (Model JM-103) User Manual (usr070)
Clinical Performance Summary Introduction The Jaundice Meter (JM-103) has been the subject of clinical studies in Japan and the United States. The following is a summary review of two clinical studies in the US and a later study in the doctor’s office setting.
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 A - 2 Jaundice Meter (JM-103) User Manual (usr070)
Page 53
Clinical Study A and specifically with the Beakman-Colter Synchron LX-20by in Hospital Study B. Both systems were used int he doctors’ office study as well. Graph 1 – Hospital Study Site A All Patients, Forehead Jaundice Meter (JM-103) User Manual (usr070) Page A - 3...
Page 54
DRAFT 20 June 2005 Graph 2 – ospital Study Site A All Patients, Sternum Graph 3 – Hospital Study Site A African-American Patients, Forehead Page A - 4 Jaundice Meter (JM-103) User Manual (usr070)
Page 55
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 (JM-103) User Manual (usr070) Page A - 5...
Page 56
DRAFT 20 June 2005 Graph 6 – Hospital Study Site A Causasian Patients, Sternum Graph 7 – Hospital Study Site A Other Patients, Forehead Page A - 6 Jaundice Meter (JM-103) User Manual (usr070)
Page 57
DRAFT 20 June 2005 Graph 8 – Hospital Study Site A Other Patients, Sternum Graph 9 – Hospital Study Site B All Patients, Forehead Jaundice Meter (JM-103) User Manual (usr070) Page A - 7...
Page 58
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 (JM-103) User Manual (usr070)
Page 59
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 (JM-103) User Manual (usr070) Page A - 9...
Page 60
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 (JM-103) User Manual (usr070)
Page 61
DRAFT 20 June 2005 Graph 16 – Hospital Study Site B Other Patients, Sternum Jaundice Meter (JM-103) User Manual (usr070) Page A - 11...
Page 62
(n=35) SITE B Sternum Cauca- 1.22 -1.69 0.88 1.81 sian (n=35) SITE B Forehead Other 1.03 -0.56 0.94 1.49 (17) SITE B Sternum Other 1.03 0.65 0.97 0.94 (17) Page A - 12 Jaundice Meter (JM-103) User Manual (usr070)
Page 63
DRAFT 20 June 2005 Graph 17 – Hospital Study Site A Error Plot, Forehead Graph 18 – Hospital Study Site A Error Plot, Sternum Jaundice Meter (JM-103) User Manual (usr070) Page A - 13...
Page 64
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 (JM-103) User Manual (usr070)
Page 65
Up to 999 1000 - 1499 1500 - 1999 2000 - 2499 2500 - 2999 3000 - and up Unknown Total Graph 22 – Hospital Study Site A Birthweight Error Plot, Forehead Jaundice Meter (JM-103) User Manual (usr070) Page A - 15...
Page 66
467 babies. Three independent measurements were taken at each site, forehead and sternum. Each measurement was recorded, the mean and standard deviation computed and recorded. The average standard deviation for forehead and sternum measurements was 0.3 for both. Page A - 16 Jaundice Meter (JM-103) User Manual (usr070)
Page 67
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. Jaundice Meter (JM-103) User Manual (usr070) Page A - 17...
Page 68
DRAFT 20 June 2005 NOTES: Page A - 18 Jaundice Meter (JM-103) User Manual (usr070)
DRAFT 20 June 2005 Appendix B Doctors’ Office Data Study Design Studies were performed at 2 doctors’ office sites comparing JM-103 Total Calculated Bilirubin (TcB) versus 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 70
All infants were measured at the sternum location ONLY . Number of Doctors’ Office Sites For the doctor’s office study, two sites were chosen for application of the device. Sample size was 201 patients. Page B - 2 Jaundice Meter (JM-103) User Manual (usr070)
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 72
DRAFT 20 June 2005 Graph 1 – Infant Age, Doctors’ Office #1 Graph 2 – Infant Age, Doctors’ Office #2 Page B - 4 Jaundice Meter (JM-103) User Manual (usr070)
Page 73
Y = -0.636 + 0.977 X Root Mean Square Error (MSE) = 1.572 R-Square = 0.804 95% Confidence Interval (CI) for the Intercept = (-1.526, 0.254) 95% CI for the Slope = (0.894, 1.061) Jaundice Meter (JM-103) User Manual (usr070) Page B - 5...
Page 74
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) Page B - 6 Jaundice Meter (JM-103) User Manual (usr070)
Page 75
Sample Size = 201 Y = 0.233 +0.934 X Root MSE = 1.54 R-Square = 0.899 95% CI for the Intercept = (-0.233, 0.37) 95% CI for the Slope = (0.934, 0.032) Jaundice Meter (JM-103) User Manual (usr070) Page B - 7...
This data supports the use of this non-invasive device along with other clinical indicators as a aid in the management of jaundice in the neonatal patient population. Page B - 8 Jaundice Meter (JM-103) User Manual (usr070)
Indian neonates. Indian J Med Res, 1987 Jul. Bhutta ZA, et al; Transcutaneous bilirubinometry in Pakistani newborns: a prelimi- nary report. JPMA J Pak Med Assoc, 1991 Jul. Jaundice Meter (JM-103) User Manual (usr070) Page C - 1...
Page 78
J Pediatr, 1983 Dec. Chen ZL, et al; Clinical use of transcutaneous bilirubinometry. Chung Hua I Hsueh Tsa Chih, 1986 Jan. Christo GG, et al; Transcutaneous bilirubinometry in newborns. Indian Pediatr, 1988 Nov. Page C - 2 Jaundice Meter (JM-103) User Manual (usr070)
Page 79
Early Hum Dev, 1990 Apr, 22:1, 23-8 Foged N, et al; Transcutaneous bilirubinometry. A non-invasive method of measur- ing physiological jaundice. Ugeskr Laeger, 1983 Sep. 19. Jaundice Meter (JM-103) User Manual (usr070) Page C - 3...
Page 80
Hegyi T Transcutaneous bilirubinometry: a new light on an old subject. Pediatrics, 1982 Jan. Hegyi T, et al; Transcutaneous bilirubinometry II. Dermal bilirubin kinetics during phototherapy. Pediatr Res, 1983 Nov. Page C - 4 Jaundice Meter (JM-103) User Manual (usr070)
Page 81
The methodical recommendations. Russia ministry of public health. 1992 Feb. Keshishjan E.S., et al; Transcutaneous bilirubinometry method at newborn jaundice diag- nostics and control. The Russian bulletin perinatology and pediatrics, V38, 5, 1993 Jaundice Meter (JM-103) User Manual (usr070) Page C - 5...
Page 82
Early Human Development 1991;25:37-41. Knudsen A. The influence of the basal yellow colour of the skin at birth on later jaundice meter readings in mature newborn infants. Acta Pediatr Scand 1992;81:494-97. Page C - 6 Jaundice Meter (JM-103) User Manual (usr070)
Page 83
The clinical application of transcutaneous bilirubinometry in full- term Chinese infants. Acta Paediatr Sin, 1993 Mar-Apr. Linder N, et al; Noninvasive determination of neonatal hyperbilirubinemia: stan- dardization for variation in skin color. Am J Perinatol, 1994 May. Jaundice Meter (JM-103) User Manual (usr070) Page C - 7...
Page 84
Palmer DC, et al; Transcutaneous bilirubinometry: use in Australia. Aust Paediatr J, 1982 Dec. Palmer DC; et al; Jaundice: A 10 year review of 41,000 live born infants. Australian Pediatrric Journal, 1983, 19(2),86-89 Page C - 8 Jaundice Meter (JM-103) User Manual (usr070)
Page 85
J Perinatol, 1989 Jun. Sharma JN, et al; Transcutaneous bilirubinometry in newborns. Indian Pediatr, 1988 Aug. Sheridan-Pereira M, et al; Transcutaneous bilirubinometry: an evaluation. Arch Dis Child, 1982 Sep. Jaundice Meter (JM-103) User Manual (usr070) Page C - 9...
Page 86
Clinical evaluation of transcutaneous jaundice meter in full-term newborns. Acta Paediatr Sin, 1988 Nov-Dec. Tudehope DI, et al; Non-invasive method of measuring bilirubin levels in newborn infants. Med J Aust, 1982 Feb 20. Page C - 10 Jaundice Meter (JM-103) User Manual (usr070)
Page 87
Transcutaneous bilirubinometry in neonates with hyperbilirubine- mia treated with phototherapy. Cesk Pediatr, 1988 Dec. 105. Weiss WJ A completely implanted left ventricular assist device. Chronic in vivo testing. ASAIO J 39(3), M427-M432, 1993 Jaundice Meter (JM-103) User Manual (usr070) Page C - 11...
Page 88
Transcutaneous bilirubinometry: effect of postnatal age. Acta Paediatr Jpn, 1991 Oct. 115. Yamauchi Y, et al; Transcutaneous bilirubinometry: variability of TcB measurements on the forehead with crying. Acta Paediatr Jpn, 1991 Oct. Page C - 12 Jaundice Meter (JM-103) User Manual (usr070)
Page 89
Yamauchi Y, et al; Factors affecting transcutaneous bilirubin measurement: effect of daylight. Acta Paediatr Jpn, 1991 Oct. 117. Yip WC, et al; Transcutaneous bilirubinometry [letter] Acta Paediatr Scand, 1983 Mar. Jaundice Meter (JM-103) User Manual (usr070) Page C - 13...
Page 90
DRAFT 9 Nov 2004 NOTES: Page C - 14 Jaundice Meter (JM-103) User Manual (usr070)
Page 91
PROPRIETARY AND CONFIDENTIAL DRAFT 5/14/04...
Page 92
Manufactured by: Distributed by: EC Representative: Konica Minolta Sensing, Draeger Medical Sys- Konica Minolta Sensing Inc. tems, Inc. Europe B.V. 3-91, Daisennishimachi 3135 Quarry Road Edisonbaan 14-E Sakai-ku, Sakai, Osaka Telford, PA 18969 USA 3439MN Nieuwegein, 590-8551 Japan the Netherlands USA and Canada Cus- tomer Support: Tel: +31 30 248 1166...
Need help?
Do you have a question about the JM-103 and is the answer not in the manual?
Questions and answers