Konica Minolta JM-103 Bedienungsanleitung

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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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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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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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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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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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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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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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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