Konica Minolta JM-103 User manual

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

Jaundice Meter (Model JM-103) User Manual (usr070rb)

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page i
Table of Contents
Section 1: Symbol Definition and Intended Use
Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 3
Section 2: Introduction, Features, and Specifications
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1
Measuring Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1
Explanation of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 3
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 6
Controls, Indicators, and Connections . . . . . . . . . . . . . . . .2 - 6
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 8
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 9
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -10
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 10
Regulations, Standards, and Codes . . . . . . . . . . . . . . . . . .2 - 11
Section 3: Precautions and Safety Tips
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 1
Safety Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 3
Warning and Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 4
Section 4: Installation and Assembly
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 - 1
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 - 1
Selecting the Unit of Measurement. . . . . . . . . . . . . . . . . . .4 - 3
Operational Checkout of the Jaundice Meter . . . . . . . . . . .4 - 4
Section 5: Instructions for Use
Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 - 1
Taking Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 - 1
Setting the Number of Average Measurements . . . . . . . . .5 - 4
Taking Average Measurements. . . . . . . . . . . . . . . . . . . . . .5 - 5

Page ii Jaundice Meter (Model JM-103) User Manual (usr070rb)
Section 6: Cleaning, Maintenance, and Replacement Parts
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Steam Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Cleaning Hard to Clean Spots . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Replacement Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Section 7: Troubleshooting
Service Calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2
Section 8: Storage and Handling
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 - 1
Section 9: Warranty
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 - 1
Appendix A: Clinical Performance Summary
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
Performance Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 2
Error Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 12
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 16
Appendix B: Medical and Scientific References on Transcutaneous
Bilirubinometry (1979 - 1997)

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 1 - 1
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.
•Boldface text—emphasizes a word or phrase.
•NOTE:—sets apart special information or important instruction
clarification.
• The symbol below highlights a WARNING or CAUTION:
Warning and Caution
– A WARNING identifies situations or actions that may affect
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 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. An F-type applied part indicates an applied part
isolated from all other parts of the instrument to such a degree
that the patient leakage current allowable in a single-fault
condition is not exceeded when a voltage equal to 1.1 times the
highest-rated mains voltage is applied between the applied part
and ground.

Page 1 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)
• The symbol below highlights an ELECTRICAL SHOCK HAZARD
WARNING:
Electrical 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 symbol below indicates RESET:
RESET Button Symbol
• The symbol below, when applied to the device, indicates:
ATTENTION: Consult Accompanying Documents

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 1 - 3
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. The device is not intended as a
standalone for diagnosis of hyperbilirubinemia. It is to be used in
conjunction with other clinical signs and laboratory measurements.
Newborn infants whose Jaundice Meter (JM-103) test results are
indicative of hyperbilirubinemia are evaluated by their doctor(s) for
appropriate patient management. Bilirubin levels should be confirmed
by other methods, such as serum bilirubin, prior to treatment
determinations.
Intended Use of the User Manual
This manual provides instructions for installation, use, operator
maintenance, and troubleshooting of the Jaundice Meter (JM-103) from
Konica Minolta and Hill-Rom Air-Shields. Konica Minolta/Hill-Rom
Air-Shields 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. Only qualified service
personnel should perform repair. Service information is available
through your local distributor or Konica Minolta/Hill-Rom Air-Shields.

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NOTES:

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 1
SPECIFICATIONS
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. The
measurements are taken automatically when you place the instrument’s
measuring probe against the forehead or sternum of the infant and press
it gently; the measured value is then displayed.
The Jaundice Meter (JM-103) measures the yellowness of the
subcutaneous tissue in infants through the detection of the optical
density difference at two wavelengths. It displays a measured value that
has been shown to correlate with serum bilirubin. The device is intended
for use in the hospital to assist clinicians in monitoring the status of
infants for the development of hyperbilirubinemia. The device is not
intended as a standalone for diagnosis of hyperbilirubinemia. It is to be
used in conjunction with other clinical signs and laboratory
measurements. Infants whose Jaundice Meter (JM-103) test results are
indicative of hyperbilirubinemia are evaluated by their doctor(s) for
appropriate patient management. Bilirubin levels should be confirmed
by other methods (e.g. serum bilirubin) prior to treatment
determinations.
Measuring Point
Measurements must be taken only on the infant’s forehead or sternum
wherea sufficient amountof blood is circulated. A possibility exists that
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.
The measuring points for this device include the forehead and the
sternum of the infant. Although correlation with serum bilirubin was
observed for both forehead and sternum measurements, the clinical
studies performed with the Jaundice Meter (JM-103) show consistently
better results with measurements taken at the sternum versus the
forehead.

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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.
Phototherapy
WARNING:
Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion. Patient injury could occur.