Konica Minolta JM-103 Bedienungsanleitung

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.

Page 1 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)

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.

Page 2 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)

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.

Andere Handbücher für JM-103

Inhaltsverzeichnis

Andere Konica Minolta Messgerät Handbücher

Konica Minolta

Konica Minolta CHROMA METER Bedienungsanleitung

Konica Minolta

Konica Minolta CM-3630 Bedienungsanleitung

Konica Minolta

Konica Minolta CM-600d Bedienungsanleitung

Konica Minolta

Konica Minolta CS-150 Bedienungsanleitung

Konica Minolta

Konica Minolta CA-2000 Bedienungsanleitung

Konica Minolta

Konica Minolta CA-100PLUS Bedienungsanleitung

Konica Minolta

Konica Minolta CM-3700A-U Bedienungsanleitung

Konica Minolta

Konica Minolta CL-200A Bedienungsanleitung

Konica Minolta

Konica Minolta SPECTRAMAGIC NX - Bedienungsanleitung

Konica Minolta

Konica Minolta CM3610D Bedienungsanleitung

Konica Minolta

Konica Minolta CM-3700D Bedienungsanleitung

Konica Minolta

Konica Minolta CR-20 Bedienungsanleitung

Konica Minolta

Konica Minolta REGIUS 210 Bedienungsanleitung

Konica Minolta

Konica Minolta cm-5 Bedienungsanleitung

Konica Minolta

Konica Minolta SPAD-502 PLUS Bedienungsanleitung

Konica Minolta

Konica Minolta bizhub C3100i Bedienungsanleitung

Konica Minolta

Konica Minolta CL-70F Bedienungsanleitung

Konica Minolta

Konica Minolta CR-10 Bedienungsanleitung

Konica Minolta

Konica Minolta Vivid 910 Bedienungsanleitung

Konica Minolta

Konica Minolta MULTI GLOSS 268 Bedienungsanleitung

Konica Minolta

Konica Minolta REGIUS SIGMA2 Bedienungsanleitung

Konica Minolta

Konica Minolta SKR 4000 Bedienungsanleitung

Konica Minolta

Konica Minolta CM-3700A Bedienungsanleitung

Konica Minolta

Konica Minolta CA-100PLUS Bedienungsanleitung

Beliebte Messgerät Handbücher anderer Marken

Suaoki

Suaoki D40 Bedienungsanleitung

Elster

Elster BK-G1.6 Bedienungsanleitung

Endress+Hauser

Endress+Hauser Deltabar FMD71 Handbuch

Duratool

Duratool D03128 Bedienungsanleitung

Vega

Vega VEGAPULS 65 Bedienungsanleitung

Tonghui

Tonghui TH2618B Bedienungsanleitung

Tenmars

Tenmars TM-801 Bedienungsanleitung

MSR

MSR 145 Bedienungsanleitung

TPS

TPS WP-82 Bedienungsanleitung

PCB Piezotronics

PCB Piezotronics 003C30 Bedienungsanleitung

Tenma

Tenma 72-10465 Bedienungsanleitung

Endress+Hauser

Endress+Hauser Proline Promag 50 Technische Daten

Siemens

Siemens SITRANS F Coriolis FCT030 Stücklistenhandbuch

KLINGER

KLINGER CMF V Series Bedienungsanleitung

Keysight

Keysight M8290A Bedienungsanleitung

Acterna

Acterna MS1400 Bedienungsanleitung

R&S

R&S ZPH Bedienungsanleitung

Datacolor

Datacolor ColorReader DC10-2 Bedienungsanleitung