Dräger JM-103 Manual de usuario

WARNING

To properly use this medical

device, the user must obtain a

full understanding of the per-

formance characteristics of

this medical device prior to

use by carefully reading these

Instructions for Use.

Model JM-103

Instructions for Use

Dräger Jaundice Meter

PROPRIETARY AND CONFIDENTIAL DRAFT 9 Nov 04

Jaundice Meter Instructions for Use (MU01380) Page i

Table of Contents

Section 1: Symbol Definition and Intended Use

Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4

Section 2: Introduction, Features, and Specifications

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1

Measuring Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1

Explanation of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 2

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

Device Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 11

Electromagnetic Compatibility (EMC) Guidance and

Manufacturer’s Declarations . . . . . . . . . . . . . . . . . . . . . . .2 - 12

Section 3: Precautions and Safety Tips

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 1

Electromagnetic Compatibility Precautions . . . . . . . . . . . .3 - 3

Safety Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 4

Warning and Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 5

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

Page ii Jaundice Meter Instructions for Use (MU01380)

Setting the Number of Average Measurements . . . . . . . . . 5 - 5

Taking Average Measurements . . . . . . . . . . . . . . . . . . . . . 5 - 6

Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and

Handling

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1

Steam Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1

Cleaning Difficult to Access Areas . . . . . . . . . . . . . . . . . . 6 - 1

Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2

Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 - 2

Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 3

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 4

Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 5

Section 7: Troubleshooting

Service Calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2

Appendix A: Clinical Performance Summary

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1

Study Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1

Performance Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 3

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 17

Appendix B: Doctors’ Office Data

Study Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B - 1

Performance Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B - 3

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B - 8

Appendix C: Medical and Scientific References on Transcutaneous

Bilirubinometry

DRAFT 18 May 2005

Jaundice Meter Instructions for Use (MU01380) 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.

• GMDN—Global Medical Device Nomenclature

• UMDNS—Universal Medical Device Nomenclature System

•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.

DRAFT 18 May 2005

Page 1 - 2 Jaundice Meter Instructions for Use (MU01380)

• 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.

• 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

DRAFT 18 May 2005

Jaundice Meter Instructions for Use (MU01380) Page 1 - 3

• The symbol below, when applied to the device, indicates:

ATTENTION: Consult Accompanying Documents

• The symbol below, when applied to the device, indicates:

ATTENTION: Consult Instructions for Use

• The symbol below, when applied to the device, indicates:

Do Not Throw Away

DRAFT 18 May 2005

Page 1 - 4 Jaundice Meter Instructions for Use (MU01380)

Intended Use

WARNING:

Magnetic Resonance Imaging (MRI) procedures interfere with

Jaundice Meter operation. Inaccurate readings could occur.

WARNING:

Do not use a mobile telephone when using the Jaundice Meter. A

measurement error could occur.

Intended Use of the Jaundice Meter

The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It

measures yellowness of subcutaneous tissue in newborn infants. The

unit provides a visual digital measurement that has been shown to

correlate with serum bilirubin in newborn infants.

The device is intended for use in hospitals or doctors’ offices under a

physician’s supervision or at their direction to assist clinicians in

monitoring of newborn infants. The device is not intended as a stand-

alone screening device for diagnosis of hyperbilirubinemia. It is to be

used as a screening device in conjunction with other clinical signs and

laboratory measurements.

Newborn infants whose Jaundice Meter test results are indicative of

hyperbilirubinemia should be evaluated by their physician(s) for

appropriate patient management. Specific neonatal patient bilirubin

levels should be confirmed by other methods, such as serum bilirubin,

prior to treatment determinations.

The Jaundice Meter is not intended for home use.

Limitations (Doctors’ Office Use)

Use only on infants up to 14 days of age.

For doctors’ office application, use only the sternum location when

taking measurements.

Please be aware, performance in doctors’ offices may vary from

performance in hospitals.

DRAFT 18 May 2005

Jaundice Meter Instructions for Use (MU01380) Page 1 - 5

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.

Intended Use of the User Manual

This manual provides instructions for installation, use, operator

maintenance, and troubleshooting of the Jaundice Meter. Draeger

Medical 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.

DRAFT 18 May 2005

Page 1 - 6 Jaundice Meter Instructions for Use (MU01380)

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