jm-103_instuctions_for_use_edition_12_may_2012.pdf
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 3
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)
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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)
Page 1 - 1
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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)
Page 2 - 1
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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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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Jaundice Meter Instructions for Use (MU01380)
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DRAFT 20 June 2005
Processing of Measured Values
Jaundice Meter Instructions for Use (MU01380)
Page 2 - 5
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
Jaundice Meter Instructions for Use (MU01380)
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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.
Jaundice Meter Instructions for Use (MU01380)
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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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Jaundice Meter Instructions for Use (MU01380)
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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)
Page 2 - 15
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.
Page 26
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.
Page 2 - 16
Jaundice Meter Instructions for Use (MU01380)