Dräger JM-103 Instructions Manual

Instructions for Use

Dräger Jaundice Meter

WARNING
To properly use this medical
device, the user must obtain a
full understanding of the per­formance characteristics of
this medical device prior to
use by carefully reading these
Instructions for Use.

Model JM-103

PROPRIETARY AND CONFIDENTIAL DRAFT 9 Nov 04

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

Jaundice Meter Instructions for Use (MU01380) Page i

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

Page ii Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005

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.

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

DRAFT 18 May 2005

• 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

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DRAFT 18 May 2005

• 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

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

DRAFT 18 May 2005

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 stand­alone 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.

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DRAFT 18 May 2005

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.

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

DRAFT 18 May 2005

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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 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 placing the instrument’s measuring probe
against the measuring site of the infant and pressing it gently; the
measured value is then displayed.

Measuring Point

Measurements must be taken only on the infant’s sternum (at hospital
sites or physicians’ offices) or forehead (at hospital sites only) where a
sufficient amount of 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.

Although correlation with serum bilirubin was observed for both
sternum and forehead measurements, the clinical studies performed with
the Jaundice Meter and referenced in Appendices A and B show
consistently better results with measurements taken at the sternum
versus the forehead. There is a possibility that this difference may be
more pronounced for infants that have been exposed to sunlight, such as
infants seen at doctors’ offices. Only sternum measurements were
evaluated during the studies conducted at doctors’ offices; correlation of
forehead measurements with serum bilirubin has not been evaluated,
and the device is not intended for forehead measurements at doctors’
offices.

NOTE:

Use the sternum location when taking measurements at doctors’ offices.

SPECIFICATIONS

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DRAFT 20 June 2005

Phototherapy

WARNING:

Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion. Results may be inaccurate under
these conditions.

Explanation of the Test

Measuring Principle

The Jaundice Meter determines the yellowness of an infant’s
subcutaneous tissue by measuring the difference in the optical densities
for light in the blue (450 nm) and green (550 nm) wavelength regions.
The measuring probe has two optical paths. This method allows for a
more precise measurement of yellowness in an infant’s subcutaneous
tissue by minimizing the influences of the melanin pigment and the skin
maturity.

When the measuring probe is pressed against the sternum or forehead of
the infant, the built-in xenon lamp flashes. The light from the xenon
lamp passes through the glass fiber and illuminates the skin. The light
scatters and is absorbed in the skin and subcutaneous tissue repeatedly,
and then finally returns to the sensor side of the glass fiber. Of the light
that returns, the part scattered from the shallow areas of the

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DRAFT 20 June 2005

subcutaneous tissue passes through the inner core, or short-optical path,
of the fiber. The part scattered from the deep areas of the subcutaneous
tissue passes through the outer core, or long-optical path, and then
reaches its corresponding photodiode.

SPECIFICATIONS

By calculating the difference in the optical densities, the parts that are
common to the epidermis and dermis are deducted, and as a result, the
difference in the optical densities between the two wavelength regions
can be obtained for the subcutaneous tissue only. Since the optical
density difference shows a linear correlation with the total serum
bilirubin concentration, it is converted to the estimated bilirubin
concentration and is indicated digitally.

The Jaundice Meter device software uses a correlation coefficient to
convert the measurement difference from the dual optical path to an
estimated bilirubin concentration. The calculation formula used includes
the correlation coefficients α and γ. These coefficients were determined
in pre-clinical testing. The equation used is as follows:

J

= α(L-S) + γ

sample

Where L and S are the long and short optical path measurements.

Jaundice Meter Instructions for Use (MU01380) Page 2 - 3

DRAFT 20 June 2005

Use of the Device

Patient Population

The Jaundice Meter is indicated for use in neonatal patients born >35
weeks gestation who have not undergone transfusion or phototherapy
treatment.

Averaging of Measurements

Averaging measurements may allow for more precise results. Averaging
three or more readings, computed automatically by the Jaundice Meter
when the desired number of measurements is set (see “Setting the
Number of Average Measurements” on page 5-5), provides more
precise transcutaneous bilirubin measurements than using a single
measurement. Assess the advantages of using average measurements at
your facility. The mean of three measurements showed the highest
degree of correlation (r=0.965); however, the difference compared to a
single measurement was minimal with a single measurement (r=0.963).
Each facility should consider the advantages of averaging multiple
measurements versus using single measurements.

Averaging was not evaluated in the doctors’ office study.

Action Levels

Action levels are Jaundice Meter readings when the nurse must take
some type of action, as determined by individual facility policy, for
example: reporting results immediately to the physician, or obtaining a
serum total serum bilirubin. A facility’s action level may be determined
by the performance of the device in their unique population, which
depends on factors such as skin color, skin thickness, infant age, and
measuring site. The bias relative to serum bilirubin differs between
hospital versus physicians’ office sites (see Appendices A and B).
Different action levels may be appropriate for hospital versus
physicians’ offices.

NOTE:

Using proper action levels avoids false negatives - where an infant is
believed not to have significant jaundice but does, in fact, have
significant jaundice that might require treatment.

Calibration

The JM-103 does not require user calibration. The system includes a
checker that measures the intensity of light from the device to ensure the
light output is acceptable for proper use. Light intensity must be
checked daily.

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DRAFT 20 June 2005

Processing of Measured Values

The Jaundice Meter determines the yellowness of the subcutaneous
tissue by measuring the difference in the optical densities for light in the
blue and green wavelength regions. The optical density difference has
been shown to have a linear correlation with serum bilirubin
concentration. The device computes an estimated bilirubin
concentration based on this linear correlation and provides the value on
the display.

SPECIFICATIONS

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DRAFT 20 June 2005

Features

Controls, Indicators, and Connections

Controls, Indicators, and Connections

Name Function

A Power switch Turns the Jaundice Meter on and off.

When used with the Reset button, the device
switches to Check Mode and changes the unit
of measurement.

B Measuring probe Takes the measurement when pressed against

the measuring point.

C Charger section Connects the charger unit to the charger sec-

tion.

D Display Displays the measured value.

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DRAFT 20 June 2005

Name Function

E Ready lamp Illuminates to indicate that the Jaundice Meter

is ready for the next measurement.

F Strap attachment area Is where the strap attaches.

G Reset button Deletes the currently displayed measured

value and prepares for the next measurement.
When used with the Power switch, the device
switches to Check Mode and changes the unit
of measurement.

H DC plug Connects the charger’s DC jack to the unit.

NOTE:

Choose the appropriate power cord
adapter for country of use.

I Checker cover Covers the checker. Open this checker cover

to check the Jaundice Meter.

J DC jack Connects the AC adapter to the charger.

K Charger lamp Illuminates to indicate that the Jaundice Meter

is charging.

L Charger jack Connects the main body to the charger.

M Standard checker

values

N Checker Checks for the intensity of light output by tak-

For reference.

ing measurements in Check Mode.

SPECIFICATIONS

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DRAFT 20 June 2005

Display

Name Function

A AVG Illuminates during averaging measurement.

B Optical path indicator

(•)

C Value Displays the measured value.

D Unit of measurement Displays the unit of measurement in either

E Battery indicator When the battery power is low, the battery

When verifying light output with the checker,
(•)illuminates when the L-value appears and
extinguishes when the S-value appears.

NOTE: When the measured value is greater
than 20 mg/dl or 340 μmol/L, the display
shows “---” and the physician should be con­tacted.

milligrams per deciliter (mg/dL) or micro­moles of solute per liter (μmol/L)

indicator blinks. Charge the battery as soon as
possible (see “Charging the Battery” on page
4-1).
If only the battery indicator illuminates, the
battery has run out. Go to “Charging the Bat­tery” on page 4-1.
If the power is on and the display is blank, the
battery is completely exhausted. Go to
“Charging the Battery” on page 4-1.

Page 2 - 8 Jaundice Meter Instructions for Use (MU01380)

Standard Features

• Jaundice Meter (JM-103)

DRAFT 20 June 2005

• Charger unit (Model JM-A30) with a checker

• AC adapter (Model JM-A32)

• Carrying case and wrist strap

• Power cable adapter set

SPECIFICATIONS

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DRAFT 20 June 2005

Specifications

Standard Features

Feature Dimension

Model name JM-103

Measuring method Determines the yellowness of the

subcutaneous tissue by using two
optical paths to measure the optical
density difference at two wave­lengths

Measurement range 0.0 mg/dL to 20 mg/dL or 0 μmol/L

to 340 μmol/L

Clinical Data Standard Error of
Estimate (SEE) *

Light source Pulse xenon arc lamp

Light source life 150000 measurements

Detectors Silicon photodiodes

Power source 2.4 V, Special Ni-MH battery

Protection type and level Internally-powered instrument, BF-

Minimum number of
measurements when fully charged

Operating temperature range 10°C (50°F) to 40°C (104°F)

Operating relative humidity range 30% to 95% non-condensing

Storage temperature range -10°C (14°F) to 50°C (122°F)

Storage relative humidity range 30% to 95% non-condensing

Dimensions 4.8 cm (1.9") wide x 15.4 cm (6.0")

Weight, including Ni-MH battery 150 g (5.3 oz)

AC adapter input 100V - 240V 50/60Hz, 11-18VA

± 1.5 mg/dL or ± 25.5 μmol/L

type

400 single measurements

high x 3.2 cm (1.2") deep

*The standard deviation shown above is based on the average of the
clinical data available. On average, 66% of results fall within this range,
and the remainder fall outside this range. This value can be affected by
variables such as age, skin color, and preformance of the device in the
hands of the user. Refer to Appendixes A and B for a detailed
description of results by clinical site, measurement location, and patient
demographics. The SEE shown in the table are based on the clinical data

Page 2 - 10 Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005

available and can be affected by variables such as infant developmental
age, ethnicity, etc. Therefore, we recommend that the JM-103 be used in
conjunction with other clinical signs and laboratory measurements.
"Specific Bilirubin Measurement" should be confirmed by other
methods such as laboratory blood serum analysis.

Regulations, Standards, and Codes

In North America, with respect to electrical shock, fire, and mechanical
hazards only, this instrument complies with UL 60601-1 and CAN/CSA
C22.2 No. 601.1.

In Europe, this instrument complies with EN60601-1, EN60601-1-2,
and EN ISO13485, and EN ISO14971.

Directive 2002/96/EC of the European Parliament and of the Council of

2003-01-27 on Waste Electrical and Electronic Equipment (WEEE)
Annex IV, prEN 50419 applies.

Device Classification

The Jaundice Meter (JM-103) meets the requirements for the following
classifications:

• Protection against electrical shock: Internally powered

• Type of applied part: BF

• IPX0—ordinary equipment (Degree of protection against harmful
ingress of water: Not applicable.)

SPECIFICATIONS

• Not suitable for use in the presence of flammable anesthetic mixture
with air or oxygen or nitrous oxide.

• Mode of operation of equipment: Continuous while in use (IEC
60601-1)

• Classification in accordance with EU Directive 93/42/EEC: IIa

• UMDNS code/GMDN code: 16-166/35475

Jaundice Meter Instructions for Use (MU01380) Page 2 - 11

DRAFT 20 June 2005

Electromagnetic Compatibility (EMC) Guidance and
Manufacturer’s Declarations

Guidance and Manufacturer’s Declaration—Electromagnetic

Emissions

The Jaundice Meter is intended for use in the electromagnetic envi­ronments specified below. The customer or user of the unit should
ensure that the unit is used in such environments.

Emissions Test Compliance

Radio frequency
(RF) emissions
—CISPR 11

RF emissions—
CISPR 11

Harmonic Emis­sions—IEC
61000-3-2

Voltage fluctua­tions/ flicker
emissions—IEC
61000-3-3

Group 1 The Jaundice Meter uses RF

Class B The Jaundice Meter is suitable

Class A

Complies

Electromagnetic

Environment—Guidance

energy only for its internal func­tion. Therefore, its RF emis­sions are very low and are not
likely to cause interference with
nearby electronic equipment.

for use in all establishments,
including domestic and those
directly connected to the public
low-voltage power supply net­work that supplies buildings
used for domestic purposes.

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DRAFT 20 June 2005

Guidance and Manufacturer’s Declaration—Electromagnetic

Immunity

The Jaundice Meter is intended for use in the electromagnetic envi­ronments specified below. The customer or user of the unit should
ensure that the unit is used in such environments.

Immunity

Test

Electrostatic
discharge
(ESD)—
IEC 61000­4-2

Electrical
fast tran­sient/burst
—IEC
61000-4-4

Surge—IEC
61000-4-5

IEC 60601
Test Level

± 6 kV con­tact
± 8 kV air

± 2 kV for
power sup­ply lines

± 1 kV
differential
mode

Compliance

Level

± 6 kV con­tact
± 8 kV air

± 2 kV for
power sup­ply lines

± 1 kV
differential
mode

Electromagnetic

Environment—

Guidance

The floors should be
wood, concrete, or
ceramic tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.

Mains power quality
should be that of a typical
commercial or hospital
environment.

Mains power quality
should be that of a typical
commercial or hospital
environment.

SPECIFICATIONS

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DRAFT 20 June 2005

Guidance and Manufacturer’s Declaration—Electromagnetic

Immunity

The Jaundice Meter is intended for use in the electromagnetic envi­ronments specified below. The customer or user of the unit should
ensure that the unit is used in such environments.

Immunity

Test

Voltage
dips, short
interrup­tions, and
voltage vari­ations on
power sup­ply input
lines—IEC
61000-4-11

Power fre­quency
(50/60 Hz)
magnetic
field—IEC
61000-4-8

IEC 60601

Test L e v e l

< 5% U
95% dip in

U

) for 0.5

T

cycles
40% U

(60% dip in

U

) for 5

T

cycles
70% U

(30% dip in

U

) for 25

T

cycles
< 5% U

95% dip in

) for 5

U

T

seconds

(>

T

T

T

(>

T

Compliance

Level

< 5% U

T

(>

95% dip in

U

) for 0.5

T

cycles
40% U

T

(60% dip in

U

) for 5

T

cycles
70% U

T

(30% dip in

U

) for 25

T

cycles
< 5% U

T

(>

95% dip in

) for 5

U

T

seconds

3 A/m 3 A/m The power frequency

Electromagnetic

Environment—

Guidance

Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the unit requires con­tinued operation during
power mains interrup­tions, it is recommended
that the unit be powered
from an uninterruptable
power supply or battery.

magnetic fields should be
at levels characteristic of
a typical location in a typ­ical commercial or hospi­tal environment.

NOTE:

U

is the AC mains voltage prior to the application of the test

T

level.

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DRAFT 20 June 2005

Guidance and Manufacturer’s Declaration—Electromagnetic

Immunity

The Jaundice Meter is intended for use in the electromagnetic environ­ments specified below. The customer or user of the unit should ensure
that the unit is used in such environments.

Immunity

Test

Con­ducted
RF—IEC
61000-4-6

Radiated
RF—IEC
61000-4-3

IEC

60601

Test

Level

3 Vrms
150
kHz to
80
MHz

3 V/m 3 V/m

80
MHz
to 2.5
GHz

Compli

ance

Level

Electromagnetic Environment—

Guidance

Recommended Separation Distance

3 Vrms Portable and mobile RF communica-

tion equipment should be used no
closer to any part of the Jaundice
Meter, including cables, than the rec­ommended separation distance calcu­lated from the equation applicable to
the frequency of the transmitter.

Recommended Separation Distance

d 1.2 P=

d 2.3 P=

80 MHz to 800 MHz

800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufac­turer and d is the recommended separa­tion distance in meters (m).
Field strengths from fixed RF transmit­ters, as determined by an electromag-

netic site survey
the compliance level in each frequency

b

range.

a

, should be less than

Interference may occur in the vicinity
of equipment marked with the follow­ing symbol:

SPECIFICATIONS

Jaundice Meter Instructions for Use (MU01380) Page 2 - 15

DRAFT 20 June 2005

Guidance and Manufacturer’s Declaration—Electromagnetic

Immunity

The Jaundice Meter is intended for use in the electromagnetic environ­ments specified below. The customer or user of the unit should ensure
that the unit is used in such environments.

IEC

Immunity

Test

60601

Test

Level

NOTE:

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE:

These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from
structures, objects, and people.

a. Field strengths from fixed transmitters, such as base stations for radio,

cellular/cordless telephones, land-mobile radios, amateur radio, AM and FM
radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed-RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the unit is used exceeds the
applicable RF compliance level, observe the unit to verify normal operation.
If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the unit.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be < 3

V/m.

Compli

ance

Level

Electromagnetic Environment—

Guidance

Recommended Separation Distance

Page 2 - 16 Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005

Section 3

Precautions and Safety Tips

Precautions

WARNING:

Do not use the instrument in areas where flammable or
combustible gases, such as anesthetic gases, are present. Doing
so could result in a fire. Personal injury or equipment damage
could occur.

WARNING:

If the instrument, the charger unit, or the AC adapter are
damaged, or if smoke or an odd smell occurs, do not use the
instrument, the charger unit, or the AC adapter. In such situations,
immediately turn off the instrument, unplug the AC adapter from
its power source, and contact the nearest authorized service
facility. Failure to do so could result in fire, personal injury, or
equipment damage.

WARNING:

Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion, because results may be
inaccurate under these conditions. Patient injury could occur.

SHOCK HAZARD:

Always plug the instrument into an AC outlet of the correctly rated
voltage and frequency. Failure to do so could result in fire,
personal injury, or equipment damage.

SHOCK HAZARD:

Do not disassemble or modify the instrument, the charger unit, or
the AC adapter. Fire, personal injury, or equipment damage could
occur.

CAUTION:

Do not place the instrument on an unstable or sloping surface.
The instrument or charger unit could drop or overturn. Equipment
damage could occur.

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

DRAFT 18 May 2005

CAUTION:

Do not use the instrument in direct sunlight. Equipment damage
could occur.

CAUTION:

The Jaundice Meter is a precision instrument. When using it, do
not drop it, expose it to shocks or strong vibrations, or place
heavy objects on it. Equipment damage could occur.

CAUTION:

Do not allow blood or other liquids to come in contact with the
instrument. Should blood or other liquids come in contact with the
instrument, immediately clean the instrument (see “Cleaning” on
page 6-1). Failure to do so could result in equipment damage.

CAUTION:

The instrument has a built-in, non-user-replaceable battery. Do
not disassemble the instrument to replace the battery. To replace
the battery, contact your dealer or authorized service center.
Failure to do so could result in equipment damage.

CAUTION:

Federal law restricts this device to sale by or on the order of a
physician.

Page 3 - 2 Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005

Electromagnetic Compatibility Precautions

General information on electromagnetic compatibility (EMC)
according to the international EMC standard IEC 60601-1­2: 2001

Pins of connectors identified with the ESD warning
symbol shall not be touched and not be connected
unless ESD precautionary procedures are used. Such
precautionary procedures may include antistatic
clothing and shoes, the touch of a ground stud before
and during connecting the pins or the use of electrically
isolating and antistatic gloves. All staff involved in the
above shall receive instruction in these procedures.

NOTE:

Portable and mobile RF communications equipment can affect medical
electrical equipment.

NOTE:

Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put
into service according to the EMC information provided in the technical
documentation available from Dräger Service upon request.

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