JM-103 Instruction Manual

Safety Symbols

The following symbols are used in this manual and on the instrument 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 patient 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 ACCORDANCE 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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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. to adhere to the following points WARNING Failure may result in death or serious injury.

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.

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Take special care not to allow liquid or metal objects to enter the instrument or charger unit. This may cause a fire or electric shock. Should liquid or metal objects enter the instrument, 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 occur. 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.

CAUTION

Failure to adhere to the following points may result in injury or damage to the instrument or other property.

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 surface. 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

Foreword Safety Notes 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 subcutaneous tissue decreases before the total serum bilirubin concentration 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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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

Foreword

Contents of the package

Notes on Use

● This instrument should be used under the following operating conditions. • 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 measuring probe perpendicular to the measuring 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 breakdown. ● 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 vibration. 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 instrument 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 designed for use with the JM-103, so they must never be used with any other instrument. ● This instrument emits intense light to take measurements. Measurements should only be taken of the forehead or sternum, and the instrument 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 alcohol before use.

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● This instrument should be stored under the following storage conditions. • Temperature of -10 to 60°C (14 to 140°F), relative humidity of 10 to 95%, with no condensation. • Atmospheric pressure of 700 to 1060 hPa (altitude of -400 to 3000m). ● When storing the instrument: • Do not store the instrument in an area where it will be ex-posed to water. • Do not store the instrument in an area where direct sunlight, pressure, temperature, humidity, ventilation, sunlight, dust, strong magnetic fields, and/or saline or sulphurous atmospheres may affect the instrument. • Do not store the instrument on an inclined surface or on a surface which may be subject to vibrations or physical shock. (Also avoid vibrations or physical shock during transportation.) • Do not store the instrument in areas where chemicals are stored or where gas may be emitted. • The instrument and its accessories should be cleaned thoroughly and stored properly to make sure that there will be no problems when they are used again. (For the cleaning method, refer to “Cleaning” on page 32.)

Foreword

Notes on Storage

Disposal Method

● The instrument has a built-in Ni-MH battery. Do not disassemble the instrument or remove the battery. To dispose of or replace the battery, contact the nearest KONICA MINOLTA SENSING authorized service facility. ● When disposing of the instrument or its accessories, local laws and regulations must be observed.

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Foreword

Names of Parts 1) JM-103 main body POWER switch READY lamp

Lights up to indicate that the instrument is ready for the next measurement.

• Slide this switch to turn the power ON/ OFF. • Using this switch in combination with the RESET button allows you to switch to check mode and change the unit of measurement.

Strap attachment area

Display

Attach the strap.

Displays the measured value etc. ❋For the method of reading the display, refer t o “Reading the Display” on page 12

Charger contact Measuring probe

Takes measurement when pressed against the measuring point.

Used to connect the Charger unit.

RESET button

• Deletes the currently displayed measured value and prepares for the next measurement. • Using this switch in combination with the POWER switch allows you to switch to check mode and change the unit of measurement. • In addition, holding this button down allows you to set the number of average measurements to be performed.

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Foreword

2) Charger unit JM-A30 Standard checker values

Checker cover

The reference values for check mode are given.

To check the instrument, open this cover.

Charger jack

Used to connect the main body.

Checker

Checks whether the instrument is operating correctly by taking measurement in check mode.

Charger lamp

Lights up to indicate that the instrument is currently charged.

DC jack

Used to connect the AC adapter.

3) AC adapter JM-A31

AC Power cord’s plug DC plug

Used to connect the charger’s DC jack.

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Connect into an AC outlet.

AC Power cord 11

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Foreword

Reading the Display

The following items are displayed on the instrument display.

❋In the following drawing, all the items are lit for explanatory purposes.

In actual operation, there are no cases where all of them are lit at the same time.

Optical path

When performing inspections with the checker, this will be illuminated when the L value is displayed (long optical path) and extinguished when the S value is displayed (short optical path).

Value

The measured values, and other information will be displayed.

AVG

Lights up during averaging measurement.

Battery Indicate (Battery mark) Battery mark blinks when the battery power is low. ❋For details on battery display, refer to “Battery Indication” on page 30.

Unit

Displays the unit of measurement. (mg/dL or μ mol/L)

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Preparation

1) Charging

● Ensure that the batteries have been charged when using it for the first time. ● Ensure that JM-103 should be always placed in the charger unit to charge the battery when not using the instrument for measurement. ● The battery display will blink when the battery power is low.

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Preparation

Before starting measurements using this instrument, follow the procedure given below to ensure that measurements are stable.

The power cord and AC adapter are supplied separately. Before using the instrument, make sure that the power cord is connected to the AC adapter. Connect the AC adapter’s DC plug to the DC jack of the Charger unit.

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DC jack

DC plug 13

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3 Preparation

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Connect the AC Power cord’s plug into an AC outlet.

Set the POWER switch on the main body to OFF, and then place the instrument on the charger unit.

◆ Make sure that the display faces toward you. When the instrument is set on the Charger unit properly, the CHARGER lamp will light up. ◆ Charging will be completed in approximately 32 hours. Measurement can be performed approximately 400 times with fully charged battery. ◆ Measurement can be performed approximately 100 times with 6 hours battery charged. ◆ The power of the batteries will be diminished if the instrument is left uncharged for long periods of time, so ensure that it is recharged prior to use.

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2) Inspecting

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Preparation

● The instrument can be easily checked to ascertain that it is performing measurement correctly, by using the checker supplied with the Charger unit. ● It is recommended that the instrument be checked once or more each day it is used. ● Since the configuration of this instrument differs from that of old models, never use conventional checkers. ● Do not touch the checker’s surface with fingers. If the checker gets dirty, wipe it with a soft cloth dampened with water, then wipe it with a dry cloth.

Set the POWER switch to ON while holding down the RESET button.

Release the RESET button immediately after “CHE” is displayed on the display window.

◆ If the RESET button is held down for more than 15 seconds, the unit of measurement will be switched. If this occurs, switch the unit back to the previous one. (For the method of switching the unit of measurement, refer to “Selecting the Unit of Measurement” on page 19.)

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3 Preparation

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Check to confirm that “CHE” is displayed and that the READY lamp is illuminated.

Open the checker cover.

Reference values

Place the measuring probe perpendicular to the checker, and push it gently until a click is heard.

◆ If the measuring probe is contacted aslant with the checker, place it perpendicularly and take measurement again.

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Confirm the measured value.

◆ The display will interchange between the L value (measured value of the long optical path) and the S value (measured value of the short optical path). “●” appears in the upper left corner of the display while the L value is displayed.

L value (measured value of the long optical path)

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S value (measured value of the short optical path)

Preparation

◆ The values are acceptable if both the L value and S value are within ±1.0 of the reference values indicated on the checker cover. (The L and S values indicate the hardware characteristics.) If the measured value exceeds ±1.0 of the reference value, clean both the checker and probe, then take measurement again. If ±1.0 of the reference value is still exceeded, contact the nearest KONICA MINOLTA SENSING authorized service facility.

Close the check cover.

Set the POWER switch to OFF.

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3) Attaching the Strap Strap

Preparation

Strap string

1

Pass the strap string through the strap hook.

Strap hook

2

Pass the strap through the loop of the string and then pull it to secure as shown.

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