Konica Minolta JM-103 User Manual
  1. Manuals
  2. Brands
  3. Konica Minolta Manuals
  4. Measuring Instruments
  5. JM-103
  6. User manual

Konica Minolta JM-103 User Manual

Jaundice meter
Hide thumbs Also See for JM-103:
Table of Contents

Advertisement

Quick Links

USER MANUAL
Jaundice Meter
(JM-103)
From Konica Minolta and
Hill-Rom Air-Shields

Advertisement

Table of Contents
loading

Related Manuals for Konica Minolta JM-103

Summary of Contents for Konica Minolta JM-103

  • Page 1 USER MANUAL Jaundice Meter (JM-103) From Konica Minolta and Hill-Rom Air-Shields...
  • Page 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 3: Table Of Contents

    Setting the Number of Average Measurements ..5 - 4 Taking Average Measurements..... .5 - 5 Jaundice Meter (Model JM-103) User Manual (usr070rb) Page i...
  • Page 4 Conclusion ........A - 16 Appendix B: Medical and Scientific References on Transcutaneous Bilirubinometry (1979 - 1997) Page ii Jaundice Meter (Model JM-103) User Manual (usr070rb)

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

    1.1 times the highest-rated mains voltage is applied between the applied part and ground. Jaundice Meter (Model JM-103) User Manual (usr070rb) 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 (usr070rb)

  • Page 7: Intended Use

    Intended Use Indications for the Use of the Jaundice Meter (JM-103) The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia.
  • Page 8 NOTES: Page 1 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 9: 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 (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.
  • Page 10 Phototherapy WARNING: Do not use the Jaundice Meter after initiation of phototherapy or after an exchange transfusion. Patient injury could occur. Page 2 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 11: Explanation Of The Test

    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. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 3...
  • Page 12 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 13 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.

  • Page 14: Features

    Illuminates to indicate that the Jaundice Meter is ready for the next measurement. Display Displays the measured value. D Measuring probe Takes the measurement when pressed against the measuring point. Page 2 - 6 Jaundice Meter (Model JM-103) User Manual (usr070rb)
  • Page 15 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) Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 7...

  • Page 16: Display

    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. Page 2 - 8 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 17: Standard Features

    Standard Features • Jaundice Meter (JM-103) • Charger unit (Model JM-A30) with a checker • AC adapter (Model JM-A31) Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 9...

  • Page 18: Specifications

    * This accuracy is based on the aggregate results from both clinical study groups (n=613). Refer to Appendix A for a detailed description of results by clinical site, measurement location, and patient demographics. Page 2 - 10 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 19: Regulations, Standards, And Codes

    With respect to electrical shock, fire, and mechanical hazards only, this instrument complies with UL 2601-1 and CAN/CSA C22.2 No. 601.1. In Europe, this instrument complies with EN60601-1, EN60601-1-2, and EN ISO13485, and EN ISO14971. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 11...
  • Page 20 NOTES: Page 2 - 12 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 21: Section 3: Precautions And Safety Tips

    Do not use a mobile telephone when using the Jaundice Meter. A measurement error could occur. CAUTION: The Jaundice Meter interferes with Magnetic Resonance Imaging (MRI) procedures. Inaccurate readings could occur. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 3 - 1...
  • Page 22 The instrument has a built-in, non-replaceable battery. Do not disassemble the instrument to replace the battery. To replace the battery, contact your dealer or authorized Hill-Rom service center. Failure to do so could result in equipment damage. Page 3 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 23: Safety Tips

    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.

  • Page 24: Warning And Caution Labels

    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 Page 3 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 25: Section 4: Installation And Assembly

    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 (usr070rb) Page 4 - 1...
  • Page 26 Hill-Rom service center. 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 (usr070rb)

  • Page 27: Selecting The Unit Of 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 (usr070rb) Page 4 - 3...

  • Page 28: Operational Checkout Of The Jaundice Meter

    Visually confirm that CHE appears in the display and that the Ready lamp illuminates. Open the cover of the checker. Use only the checker supplied with the Jaundice Meter (JM-103). Page 4 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)
  • Page 29 If the measured value still exceeds ± 1.0 of the reference value, contact the nearest authorized service facility. Close the cover of the checker. 10. Set the Power switch to the Off position. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 4 - 5...
  • Page 30 NOTES: Page 4 - 6 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 31: Section 5: Instructions For Use

    The measured value for a single measurement, n-1, appears on the display. Visually check that the Ready lamp illuminates. If the battery indicator blinks, charge the battery (see “Charging the Battery” on page 4-1). Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 5 - 1...
  • Page 32 If the instrument is not operated for more than 60 seconds, the backlight on the display goes out. To take another measurement, press the Reset button, and continue from step 4. Page 5 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)
  • Page 33 Using medicinal alcohol, clean the measuring probe. Place the Jaundice Meter on the charger unit. When the Jaundice Meter is not in use, keep it on the charger unit. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 5 - 3...

  • Page 34: Setting The Number Of Average Measurements

    • 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. Page 5 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 35: Taking Average Measurements

    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. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 5 - 5...
  • Page 36 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 5-4. Page 5 - 6 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 37: Section 6: Cleaning, Maintenance, And Replacement Parts

    To remove difficult spots or stains, we recommend that you use standard household cleansers and a soft bristle brush. To loosen heavy, dried-on soil, you may first need to saturate the spot. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 6 - 1...

  • Page 38: Disinfecting

    Hill-Rom service center. 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 (usr070rb)

  • Page 39: Section 7: Troubleshooting

    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 (usr070rb) Page 7 - 1...

  • Page 40: Troubleshooting

    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 (usr070rb)

  • Page 41: Section 8: Storage And Handling

    • To ensure no problems will exist the next time the main body and charger are used, thoroughly clean the main body and charger, and then store them together. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 8 - 1...
  • Page 42 NOTES: Page 8 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 43: Section 9: Warranty

    Hill-Rom will offer parts for new and remanufactured products for ten (10) years from date of sale; for communications products for five (5) years from date of sale. Note: Some original component parts and assemblies may not be available; functional equivalents may be substituted. Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 9 - 1...
  • Page 44 Revised October 1, 2003 Hill-Rom Company, Inc., 1069 State Route 46 E, Batesville, IN 47006-9167 Page 9 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

  • Page 45: Appendix A: Clinical Performance Summary

    Clinical Performance Summary Introduction The Jaundice Meter (JM-103) has been the subject of three clinical studies. One study in Japan, the other two studies in the United States. The following information is a summary of results from the two US studies.

  • Page 46: Performance Data

    The serum bilirubin measurements were taken using direct spectrophotometry in Clinical Study A and specifically with the Beakman-Colter Synchron LX-20by in Clinical Study B. Page A - 2 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 47 Graph 1 – Clinical Study Site A All Patients, Forehead Graph 2 – Clinical Study Site A All Patients, Sternum Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 3...
  • Page 48 Graph 3 – Clinical Study Site A African-American Patients, Forehead Graph 4 – Clinical Study Site A African-American Patients, Sternum Page A - 4 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 49 Graph 5 – Clinical Study Site A Caucasian Patients, Forehead Graph 6 – Clinical Study Site A Causasian Patients, Sternum Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 5...
  • Page 50 Graph 7 – Clinical Study Site A Other Patients, Forehead Graph 8 – Clinical Study Site A Other Patients, Sternum Page A - 6 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 51 Graph 9 – Clinical Study Site B All Patients, Forehead Graph 10 – Clinical Study Site B All Patients, Sternum Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 7...
  • Page 52 Graph 11– Clinical Study Site B African-American Patients, Forehead Graph 12 – Clinical Study Site B African-American Patients, Sternum Page A - 8 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 53 Graph 13 – Clinical Study Site B Caucasian Patients, Forehead Graph 14 – Clinical Study Site B Causasian Patients, Sternum Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 9...
  • Page 54 Graph 15 – Clinical Study Site B Other Patients, Forehead Graph 16 – Clinical Study Site B Other Patients, Sternum Page A - 10 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 55 1.72 Caucasian (n=35) SITE B Sternum 1.22 -1.69 0.88 1.81 Caucasian (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) Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 11...

  • Page 56: Error Plots

    Graph 18 – Clinical Study Site A Error Plot, Forehead Graph 19 – Clinical Study Site A Error Plot, Sternum Page A - 12 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 57 Graph 20 – Clinical Study Site B Error Plot, Forehead Graph 21 – Clinical Study Site B Error Plot, Sternum Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 13...
  • Page 58 Up to 999 1000 - 1499 1500 - 1999 2000 - 2499 2500 - 2999 3000 - and up Unknown Total Graph 23 – Clinical Study Site A Birthweight Error Plot, Forehead Page A - 14 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 59 467 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. Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 15...

  • Page 60: Conclusion

    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 A - 16 Jaundice Meter (JM-103) User Manual (usr070rb)

  • Page 61: Appendix B: Medical And Scientific References On Transcutaneous Bilirubinometry (1979 - 1997)

    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 (usr070rb) Page B - 1...
  • Page 62 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 B - 2 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 63 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 (usr070rb) Page B - 3...
  • Page 64 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 B - 4 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 65 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 (usr070rb) Page B - 5...
  • Page 66 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 B - 6 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 67 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 (usr070rb) Page B - 7...
  • Page 68 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 B - 8 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 69 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 (usr070rb) Page B - 9...
  • Page 70 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 B - 10 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 71 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 (usr070rb) Page B - 11...
  • Page 72 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 B - 12 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 73 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 (usr070rb) Page B - 13...
  • Page 74 NOTES: Page B - 14 Jaundice Meter (JM-103) User Manual (usr070rb)
  • Page 75 Jaundice Meter (Model JM-103) User Manual (usr070)
  • Page 76 Manufactured by: Konica Minolta Sensing, Inc. 3-91, Daisennishimachi Sakai, Osaka 590-8551 Japan Authorized Representative: Hill-Rom Europe Director Quality and Regulatory Affairs Les Rabelais - Paris Nord II 22 Avenue des Nations BP 50436 -VILLE PINTE 95 944 - Roissy CDG CEDEX France tel.

Table of Contents