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.

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• 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.

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 3
SPECIFICATIONS
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.
The measuring probe has two optical paths. This method allows for a
more precise measurement of yellowness in an infant’s subcutaneous
tissue by minimizing the influences of the melanin 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 fiber and illuminates the skin. The light
scatters and is absorbed in the skin and subcutaneous tissue repeatedly,
and then finally returns to the sensor side of the glass fiber. Of the light
that returns, the part scattered from the shallow areas of the
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.

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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
can be obtained for the subcutaneous tissue only. Since the optical
density difference shows a linear correlation with the total serum
bilirubin concentration, it is converted 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 optical
path to an estimated bilirubin concentration. The calculation formula
used includes the correlation coefficients αand γ. These coefficients
were determined in pre-clinical testing. The equation used is as follows:
Jsample = α(L-S) + γ
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.

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 5
SPECIFICATIONS
Averaging of Measurements
There was no significant difference between the averaged measurements
and the single measurement approaches in the largest study for sternum
measurements. The mean of three measurements showed the highest
degree of correlation (r=0.965), however, the difference was minimal
with a single measurement (r=0.963).
The advantages of using average measurements should be assessed at
each facility.
Action Levels
Each facility should determine their own action levels based on studies
of performance of the device on their population. Appropriate action
levels may vary depending on performance of the device, such as
precision or correlation with serum bilirubin, in the hands of the user.
Some factors that could affect performance of the device or appropriate
action levels include skin color, age, or measurement site. Careful
selection of action levels should be made so that false negatives do not
prevent appropriate follow up measures.
Calibration
There is no user calibration of this device. The system does include a
checker that measures the intensity of light from the device to ensure the
light output is within range.
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. The device computes an estimated bilirubin
concentration based on this linear correlation and provides the value on
the display. The correlation coefficient used in this computation was
derived from clinical data.

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Features
Controls, Indicators, and Connections
Controls, Indicators, and Connections
Name Function
APower 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.
BReady lamp 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 (usr070rb) Page 2 - 7
SPECIFICATIONS
E Charger section Connect the charger unit to the charger sec-
tion.
FReset button Deletes the currently displayed measured
value and prepares for the next measurement.
When used with the Power switch, the device
switchesto Check Mode and changes the unit
of measurement.
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 jack Connect the AC adapter to this jack.
K Charger jack Connect the main body to this jack.
L Checker Checks for the intensity of light output by tak-
ing measurements in Check Mode.
M Standard checker
values For reference.
N DC plug Connect the charger’s DC jack to this.
O DC Plug (interna-
tional) Connect the charger’s DC jack to this.
Name Function

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Display
Name Function
A AVG Illuminates during averaging measurement.
B Optical path indicator
(•) When performing inspections 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, 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 liter (µmol/L)
E Battery indicator When the battery power is low, the battery
indicator blinks. Charge the battery as soon as
possible (see “Charging the Battery” on page
4-1).
If only the battery indicator lights, the battery
has run out. 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 (usr070rb) Page 2 - 9
SPECIFICATIONS
Standard Features
• Jaundice Meter (JM-103)
• Charger unit (Model JM-A30) with a checker
• AC adapter (Model JM-A31)

Page 2 - 10 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Specifications
Standard Features
* 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.
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
Measurement range 0.0 mg/dL to 20 mg/dL or 0 µmol/L
to 340 µmol/L
RMSE ∗± 1.5 mg/dL or ± 25.5 µmol/L
Light source Pulse xenon arc lamp
Light source life 150000 measurements
Sensors Silicon photodiodes
Power source Special Ni-MH battery
Protection type and level Internally-powered instrument, BF-
type
Minimum number of
measurements when fully charged 400 single measurements
Operating temperature range 10°C (50°F) to 40°C (104°F)
Operating relative humidity range 30% to 95%
Storage temperature range -10°C (14°F) to 50°C (122°F)
Storage relative humidity range 30% to 95%
Dimensions 48 mm (1.9") wide x 15.5 cm (6.1")
high x 33 mm (1.3") deep
Weight, including battery 150 g (5.3 oz)
AC adapter input for North America 120V, 50/60 Hz, 10 W
AC adapter input for
International use 200V-240V, 50/60 Hz, 12.5VA
AC adapter output 9V, 500 mA

Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 11
SPECIFICATIONS
Regulations, Standards, and Codes
In North America
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.

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NOTES: