Konica Minolta JM-103 User manual

Jaundice Meter
JM-103
Instruction Manual
Incorrect use of the instrument may result in accidents, so follow the
instruction manual to ensure correct and safe operation.
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Safety Symbols
The following symbols are used in this manual and on the instru-
ment to prevent accidents that may occur as a result of incorrect
use of the instrument.
Denotes a sentence regarding a safety warning or note.
Read the sentence carefully to ensure safe and correct use.
Denotes a prohibited operation.
The operation must never be performed.
Denotes an instruction.
The instruction must be strictly adhered to.
Denotes a prohibited operation.
Never disassemble the instrument.
Denotes an instruction.
Disconnect the AC power cord from the AC outlet.
This symbol indicates type BF Applied Part. The instrument
provides a particular degree of protection against electric
shock, particularly the leakage current and reliability of the
protective earth connection with an F-TYPE APPLIED PART.
F-TYPE APPLIED PART indicates applied part isolated from
all other parts of the instrument to such a degree that the pa-
tient leakage current allowable in 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 earth.
This symbol indicates alternating current (AC).
This symbol indicates direct current (DC).
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1
Notes on this Manual
• Copying or reproduction of all or any part of the contents of this
manual without KONICA MINOLTA SENSING's permission is strictly
prohibited.
• The contents of this manual are subject to change without prior
notice.
• Every effort has been made in the preparation of this manual to ensure
the accuracy of its contents. However, should you have any questions
or find any errors, please contact a KONICA MINOLTA SENSING
authorized service facility.
• KONICA MINOLTA SENSING will not accept any responsibility for
consequences arising from the use of the instrument.
Authorized Standards
For North America
UL, cUL:
WITH RESPECT TO ELECTRICAL SHOCK,FIRE
AND MECHANICAL HAZARDS ONLYIN AC-
CORDANCE WITH UL 60601-1AND CAN/CSA
C22.2 No. 601.1
For Europe
CE (Medical Device Directive):
This instrument complies with EN60601-1,
EN60601-1-2, and EN ISO13485, and EN
ISO14971.
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2
WARNING
Do not use the instrument in areas where flammable or
combustible gases (anesthetic gas, gasoline fumes etc.) are
present. Doing so may result in a fire.
Always use the charger unit (JM-A30) and the AC adapter
(JM-A31, including the power cord) that are supplied with the
instrument, and connect the adapter to an AC outlet (100V,
50/60Hz). Using a charger unit and AC adapter other than
those mentioned above or connecting to a voltage other than
the one specified may result in damage to the instrument,
charger or AC adapter, fire or electric shock.
Do not insert or disconnect the AC power cord’s plug with
wet hands. Doing so may cause electric shock.
Do not disassemble or modify the instrument, Charger unit or
AC adapter. Doing so may cause a fire or electric shock.
SAFETY PRECAUTIONS
To ensure correct use of this instrument, read the following
points carefully and adhere to them. After reading this manual,
keep it in a safe place where it can be referred to anytime a
question arises.
Failure to adhere to the following points
may result in death or serious injury.
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3
Take special care not to allow liquid or metal objects to en-
ter the instrument or charger unit. This may cause a fire or
electric shock. Should liquid or metal objects enter the instru-
ment, turn the power OFF immediately, disconnect the AC
adapter from the AC outlet, and contact the nearest KONICA
MINOLTA SENSING authorized service facility.
The instrument, Charger unit and AC adapter should not be
operated if they are damaged, or if smoke or odd smells oc-
cur. Doing so may result in a fire. In such situations, turn
the power OFF immediately, disconnect the AC adapter from
the AC outlet, and contact the nearest KONICA MINOLTA
SENSING authorized service facility.
Failure to adhere to the following points
may result in injury or damage to the in-
strument or other property.
CAUTION
Never press the measuring probe when it is directed to the
eyes. Doing so may cause eye damage.
Do not place the instrument on an unstable or sloping sur-
face. Doing so may result in the instrument or Charger unit
dropping or overturning, causing injury. When you carry the
instrument, take care not to let it drop.
Make sure that the instrument is placed near the AC outlet
and that the AC power cord’s plug can be easily connected
and disconnected.
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4
CONTENTS
SAFETY PRECAUTIONS …………………………………………… 2
Foreword ……………………………………………………………… 5
Contents of the package …………………………………………………… 7
Notes on Use ………………………………………………………………… 7
Notes on Storage …………………………………………………………… 9
Disposal Method …………………………………………………………… 9
Names of Parts …………………………………………………… 10
1) JM-103 main body ………………………………………………………10
2) Charger unit JM-A30 ……………………………………………………11
3) AC adapter JM-A31 ………………………………………………………11
Reading the Display …………………………………………………………12
Preparation ………………………………………………………… 13
1) Charging ……………………………………………………………………13
2) Inspecting …………………………………………………………………15
3) Attaching the Strap ………………………………………………………18
4) Selecting the Unit of Measurement ……………………………………19
Measurement ……………………………………………………… 21
Setting the Number of Average Measurements ………………………21
Measuring Procedure ………………………………………………………23
Removing from Charger ……………………………………………………23
Single Measurement ………………………………………………………24
Average Measurement (example using five times as the average) ……25
Storing the Instrument ………………………………………………………28
Trouble Shootings ………………………………………………… 29
Error Messages ………………………………………………………………29
Check Points before Repairing ……………………………………………31
Maintenance and Inspections ……………………………………………32
Cleaning ………………………………………………………………………32
Specifications ……………………………………………………… 33
Appendix …………………………………………………………… 35
EMC Guidance (electromagnetic emissions) …………………………………… 35
EMC Guidance (electromagnetic immunity) …………………………………… 36
Measuring Principle …………………………………………………………38
Clinical Test Result Report …………………………………………………40
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5
Foreword
Safety Notes
Foreword
This instrument is designed for estimating total serum bilirubin
concentration, that is necessary for the screening of jaundice in
newborn infants. It must be used for newborn infants only.
Never press the measuring probe when it is directed to the eyes.
Doing so may cause eye damage.
To prevent kernicterus in newborn infants, it is very important to
detect jaundice in its early stages.
This hand-held jaundice meter allows a quick, non-invasive
estimate of total serum bilirubin concentration, necessary for the
control of jaundice in newborn infants.
Measurements are taken automatically by simply placing the
instrument’s measuring probe against the forehead or sternum
of the infant and pressing it gently, and the measured value is
displayed.
This facilitates use of the instrument for infants who are still kept
in incubators and provides suitable screening for jaundice. This
will also help detect jaundice in its early stages.
This instrument considers the yellowness of the skin, which
consists of epidermis, dermis and subcutaneous tissue as the
optical density difference at two wavelengths, and it calculates
the difference only for the subcutaneous tissue by measuring
the difference between the two optical paths.
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6
Foreword
Hemolytic jaundice
Normally, in the case of hemolytic jaundice that appears before the
age of three days, measurement of total serum bilirubin concentration
must also be taken. (The correlation between the measured value
taken by the instrument and total serum bilirubin concentration drops
substantially due to physiologic factors.)
Precocious jaundice
If there is a possibility that the newborn infant is suffering from
precocious jaundice (incompatible blood type, hemolytic jaundice),
it is necessary to take frequent measurements or measure the total
serum bilirubin concentration as well. (There is a possibility that
bilirubin concentration in the subcutaneous tissue rises slower than
the total serum bilirubin concentration.)
When the newborn infant is undergoing photo-therapy
During photo-therapy, the bilirubin concentration in the subcutaneous
tissue under the area exposed to light decreases before the total
serum bilirubin concentration does, so it is necessary to limit the use
of this instrument only when photo-therapy equipment is used from
the back of the patient or affix a light-blocking patch to the measuring
point on the forehead or chest. (In areas exposed to light, there are
some cases in which only the bilirubin concentration in the subcuta-
neous tissue decreases before the total serum bilirubin concentra-
tion improves. In addition, if the total serum bilirubin concentration
increases again after therapy, there is a possibility that the bilirubin
concentration in the subcutaneous tissue will increase later.)
Measuring point
Measurements must be taken on the forehead or sternum, where a
sufficient amount of blood is circulated. (There is a chance that the
bilirubin concentration in the subcutaneous tissue is low for areas with
small amounts of blood and areas in which the subcutaneous tissue is
subject to keratinization.)
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Foreword
Contents of the package
Before using the instrument, check to ensure that the following
items are included in the package.
1) Jaundice Merer JM-103 × 1
2) Charger Unit JM-A30 × 1
3) AC Adapter JM-A31 × 1
4) Strap × 1
5) Instruction Manual × 1
Notes on Use
● This instrument should be used under the following operating condi-
tions.
• Temperature of 0 to 40°C (32 to 104°F), relative humidity of 30 to
85%, with no condensation.
• Atmospheric pressure of 700 to 1060 hPa (altitude of -400 to
3000m).
● When taking measurements, place the mea-
suring probe perpendicular to the measur-
ing point and then push it gently as shown
below. Placing the measuring probe at an
angle may result in fluctuation of measured
value.
● This instrument is a precision instrument, so it should not be dropped,
exposed to shocks and strong vibrations, nor should heavy objects
be placed on it. Failure to observe these cautions may cause break-
down.
● Do not use the instrument in areas where it may be exposed to rain or
water since it is not splash/water-proof. Also take special care not to
allow blood or other liquids to come in contact with the instrument.
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8
Foreword
● Do not use the instrument on a point where there is excessive vibra-
tion. In addition, to avoid excessive impact on the instrument, it should
be handled gently. Failure to observe this may cause breakdown.
● Accurate measurement data may not be obtained in the following
cases.
• When ambient light (e.g. panel light, fluorescent light, infrared heat
lamp, direct sunlight) is too strong
• When influenced electromagnetically by other electronic devices
(e.g. near electrical appliances like TV, medial device)
• When a mobile telephone is used during measurement
● This instrument has a built-in battery. Do not disassemble the instru-
ment to replace the battery.
● Use the Charger unit (JM-A30) and AC adapter (JM-A31) that are
supplied with the instrument.
● The Charger unit (JM-A30) and AC adapter (JM-A31) are solely de-
signed for use with the JM-103, so they must never be used with any
other instrument.
● This instrument emits intense light to take measurements. Measure-
ments should only be taken of the forehead or sternum, and the in-
strument should never be allowed to emit light directly into the eyes.
● If the instrument gets dirty, wipe it with a dry cloth or a cloth moistened
with mild, neutral detergent. (Never use a solvent such as thinner or
benzene to clean the instrument, since it may dissolve its casing.)
● The measuring probe should be cleaned by wiping with medicinal al-
cohol before use.
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