JM-103 Instructions for Use Edition 12 May 2012

Page 1

Instructions for Use

Dräger Jaundice Meter

WARNING

To properly use this medical

device, read and comply with

these instructions for use.

Model JM-103

Page 4

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

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Jaundice Meter Instructions for Use (MU01380)

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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)

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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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Jaundice Meter Instructions for Use (MU01380)

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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)

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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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Jaundice Meter Instructions for Use (MU01380)

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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)

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Jaundice Meter Instructions for Use (MU01380)

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Section 2

Introduction, Features,

and Specifications

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.

Jaundice Meter Instructions for Use (MU01380)

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SPECIFICATIONS

Introduction

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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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Jaundice Meter Instructions for Use (MU01380)

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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:

Jsample = α(L-S) + γ

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

Jaundice Meter Instructions for Use (MU01380)

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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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Jaundice Meter Instructions for Use (MU01380)

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DRAFT 20 June 2005

Processing of Measured Values

Jaundice Meter Instructions for Use (MU01380)

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SPECIFICATIONS

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.

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DRAFT 20 June 2005

Features

Controls, Indicators, and Connections

Controls, Indicators, and Connections

Name

A Power switch

B

Measuring probe

C

Charger section

D Display

Page 2 - 6

Function

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.

Takes the measurement when pressed against

the measuring point.

Connects the charger unit to the charger section.

Displays the measured value.

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DRAFT 20 June 2005

Name

E

Ready lamp

H DC plug

I

Checker cover

J DC jack

K Charger lamp

L Charger jack

M Standard checker

values

N Checker

Illuminates to indicate that the Jaundice Meter

is ready for the next measurement.

Is where the strap attaches.

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.

Connects the charger’s DC jack to the unit.

NOTE:

Choose the appropriate power cord

adapter for country of use.

Covers the checker. Open this checker cover

to check the Jaundice Meter.

Connects the AC adapter to the charger.

Illuminates to indicate that the Jaundice Meter

is charging.

Connects the main body to the charger.

For reference.

Checks for the intensity of light output by taking measurements in Check Mode.

Jaundice Meter Instructions for Use (MU01380)

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SPECIFICATIONS

F Strap attachment area

G Reset button

Function

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DRAFT 20 June 2005

Display

Name

A AVG

B Optical path indicator

(•)

C

Value

D Unit of measurement

E

Battery indicator

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Function

Illuminates during averaging measurement.

When verifying light output with the checker,

(•)illuminates when the L-value appears and

extinguishes when the S-value appears.

Displays the measured value.

NOTE: When the measured value is greater

than 20 mg/dl or 340 μmol/L, the display

shows “---” and the physician should be contacted.

Displays the unit of measurement in either

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

When the battery power is low, the battery

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.

Jaundice Meter Instructions for Use (MU01380)

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DRAFT 20 June 2005

Standard Features

• Jaundice Meter (JM-103)

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

SPECIFICATIONS

• AC adapter (Model JM-A32)

• Carrying case and wrist strap

• Power cable adapter set

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DRAFT 20 June 2005

Specifications

Standard Features

Feature

Dimension

Model name

Measuring method

JM-103

Determines the yellowness of the

subcutaneous tissue by using two

optical paths to measure the optical

density difference at two wavelengths

0.0 mg/dL to 20 mg/dL or 0 μmol/L

to 340 μmol/L

± 1.5 mg/dL or ± 25.5 μmol/L

Measurement range

Clinical Data Standard Error of

Estimate (SEE) *

Light source

Light source life

Detectors

Power source

Protection type and level

Minimum number of

measurements when fully charged

Operating temperature range

Operating relative humidity range

Storage temperature range

Storage relative humidity range

Dimensions

Weight, including Ni-MH battery

AC adapter input

Expected service life

Pulse xenon arc lamp

150000 measurements

Silicon photodiodes

2.4 V, Special Ni-MH battery

Internally-powered instrument, BFtype

400 single measurements

10°C (50°F) to 40°C (104°F)

30% to 95% non-condensing

-10°C (14°F) to 50°C (122°F)

30% to 95% non-condensing

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

high x 3.2 cm (1.2") deep

150 g (5.3 oz)

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

5 years

*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

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Jaundice Meter Instructions for Use (MU01380)

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DRAFT 20 June 2005

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 IEC 60601-1:2005; EN 606011:2006/AC:2010; EN 60601-1-2, 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.)

• 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)

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SPECIFICATIONS

demographics. The SEE shown in the table are based on the clinical data

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.

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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 Group 1

(RF) emissions

—CISPR 11

RF emissions— Class B

CISPR 11

Harmonic Emis- Class A

sions—IEC

61000-3-2

Voltage fluctua- Complies

tions/ flicker

emissions—IEC

61000-3-3

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Electromagnetic

Environment—Guidance

The Jaundice Meter uses RF

energy only for its internal function. Therefore, its RF emissions are very low and are not

likely to cause interference with

nearby electronic equipment.

The Jaundice Meter is suitable

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

Immunity

Test

IEC 60601

Test Level

Compliance

Level

Electrostatic ± 6 kV contact

discharge

± 8 kV air

(ESD)—

IEC 610004-2

± 6 kV contact

± 8 kV air

Electrical

fast transient/burst

—IEC

61000-4-4

Surge—IEC

61000-4-5

± 2 kV for

power supply lines

± 2 kV for

power supply lines

± 1 kV

differential

mode

± 1 kV

differential

mode

Jaundice Meter Instructions for Use (MU01380)

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.

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SPECIFICATIONS

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.

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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

IEC 60601

Test Level

Compliance

Level

Voltage

dips, short

interruptions, and

voltage variations on

power supply input

lines—IEC

61000-4-11

< 5% UT (>

95% dip in

UT) for 0.5

cycles

40% UT

(60% dip in

UT) for 5

cycles

70% UT

(30% dip in

UT) for 25

cycles

< 5% UT (>

95% dip in

UT) for 5

seconds

3 A/m

< 5% UT (>

95% dip in

UT) for 0.5

cycles

40% UT

(60% dip in

UT) for 5

cycles

70% UT

(30% dip in

UT) for 25

cycles

< 5% UT (>

95% dip in

UT) for 5

seconds

3 A/m

Power frequency

(50/60 Hz)

magnetic

field—IEC

61000-4-8

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.

The power frequency

magnetic fields should be

at levels characteristic of

a typical location in a typical commercial or hospital environment.

NOTE:

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

level.

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DRAFT 20 June 2005

Guidance and Manufacturer’s Declaration—Electromagnetic

Immunity

IEC

Compli

Immunity 60601

ance

Test

Test

Level

Level

Conducted

RF—IEC

61000-4-6

3 Vrms 3 Vrms

150

kHz to

80

MHz

Radiated 3 V/m

RF—IEC

61000-4-3

80

MHz

to 2.5

GHz

3 V/m

Electromagnetic Environment—

Guidance

Recommended Separation Distance

Portable and mobile RF communication 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

80 MHz to 800 MHz

d = 2.3 P

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 electromagnetic site survey , should be less than

the compliance level in each frequency

range.

Interference may occur in the vicinity

of equipment marked with the following symbol:

a

b

Jaundice Meter Instructions for Use (MU01380)

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SPECIFICATIONS

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.

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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.

IEC

Compli

Immunity 60601

ance

Test

Test

Level

Level

Electromagnetic Environment—

Guidance

Recommended Separation Distance

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.

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Jaundice Meter Instructions for Use (MU01380)