Drager Konica Minolta Hill-Rom Air-Shields JM-103 User manual
USER MANUAL
Jaundice Meter
(JM-103)
From Konica Minolta and
Hill-Rom Air-Shields
Jaundi ce Meter (Mode l JM - 1 03) User Manual (usr 07 0r b )
Table of Contents
Section 1: Symbol Definition and Intended Use
Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 3
Section 2: Introduction, Features, and Specifications
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1
Measuring Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 1
Explanation of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 3
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 6
Controls, Indica tors, and C on n e ctions . . . . . . . . . . . . . . . .2 - 6
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 8
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 9
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -10
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 - 10
Regulations, Standards, and Codes . . . . . . . . . . . . . . . . . .2 - 11
Section 3: Precautions and Safety Tips
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 1
Safety Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 3
Warning and Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 4
Section 4: Installation and Assembly
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 - 1
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 - 1
Selecting the Unit of Measurement . . . . . . . . . . . . . . . . . . .4 - 3
Operational Chec kout of the Jaundice Meter . . . . . . . . . . .4 - 4
Section 5: Instructions f or Use
Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 - 1
Taking Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 - 1
Setting the Number of Average Measurements . . . . . . . . .5 - 4
Taking Average Measurements. . . . . . . . . . . . . . . . . . . . . .5 - 5
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page i
Section 6: Cleaning, Maintenance, and Re placement Parts
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Steam Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Cleaning Hard to Clean Spots . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Replacement Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Section 7: Troubleshooting
Service Calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2
Section 8: Storage and Handling
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 - 1
Section 9: Warranty
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 - 1
Appendix A: Clinical Performance Summary
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
Performance Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 2
Error Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 12
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 16
Appendix B: Medical and Scientific References on Transcutaneous
Bilirubinom etr y (1979 - 1997)
Page ii Jaundice Meter (Model JM-103) User Manual (usr070rb)
Section 1
Symbol Definition
and Intended Use
Symbol Definition
This manual contains different typefaces and icons des igned to improve
readabili ty and i ncrease unde rsta nding of it s cont ent. No te the foll owing
examples:
• Standard text—used for regular information.
• Boldface text—emphasize s a word or phrase.
• NOTE:—sets apart s p ec ial info r mation o r import an t instruc tion
clarification.
• The symbol below highlights a WARNING or CAUTION:
Warning and Caution
– A WARNIN G identif ies situations o r actions th at may affect
patient or user safety . Disregarding a warning could result in
patient or user injury.
– A CAUTION points out s pecial procedures or precautions that
personnel must follow to avoid equipment damage.
• The symbol below highlights a type BF applied part:
T ype BF Appli ed Part
– The instrument provi des a specified degree of protec tion
against electric shock, particularly the lea kage current and
reliability of the protective ground connection with an F-type
applied part . An F-type applied part indic ates an applied part
isolated fr om all other parts of the instrument to such a degree
that the p at ient leak ag e cur r e n t al lo w able in a sin g l e- fa u l t
condition is no t exce eded whe n a volta ge equa l t o 1.1 ti mes the
highest-rate d main s volta ge is applie d be tween t he appli ed part
and ground.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 1 - 1
• 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 ind icates that the product uses a
RECHARGEABLE BATTERY:
Rechargeable Battery Symbol
• The symbol below ind icates RESET:
RESET Button Symbol
• The symbol below, when applied to the device, indicates:
ATTENTION: Consult Accompanying Documents
Page 1 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Intended Use
Indications for the Use of the Jaundice Meter (JM-103)
The Jaundice Meter (JM-103) is a non-invasive transcutaneous
bilirubi nom eter. It measures yellowness of subcutaneous tissue in
newborn infants and displays a measured value which has been shown
to correlate with serum bilirubin. The device is for use in the hospital to
assist clinicians in monitoring the status of newborn infants for the
development of hyperbilirubinemia. The device is not intended as a
standalone for diagnosis of hyperbilirubinemia. It is to be used in
conjunction with other clinical s igns and laboratory measurements.
Newborn infants whose Jaundice Meter (JM-103) test results are
indicative of hyperbilirubinemia are evaluated by their doctor(s) for
appropriate patient management. Bilirubin levels should be confi r me d
by other methods, such as se rum bilirubin, prior to treatment
determinations.
Intended Use of the User Manual
This manual provides instructions for installation, use, operator
maintenance , and troubleshooting of the Jau ndice Meter (JM-103) from
Konica Minolta and Hill-Rom Air-S hields. Konica Minolta/Hill-Rom
Air-Shields cannot be responsi ble for the performance of the Jaun dice
Meter if the user does not oper ate the unit in accordance with the
instr uc tions, f ails to fol l ow m ainten ance rec ommen dation s , or makes
any repairs with unauthorized compon ents. Only qualified se rvice
personnel shoul d perform repair . Service information is available
through your local distributor or Konica Minolta/Hill-Rom Air-Shields.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 1 - 3
NOTES:
Page 1 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Section 2
Introduction, Features,
and Specifications
Introduction
To prevent kernict erus in newborn infants, it is very im portant to detect
jaundice in i ts earl y st ages. The Jaundice Meter (JM-103) is a noninvasive tra nscut aneous bi li rubi nometer. Th is hand-he ld d evice allows a
quick, non-invasive estimate of bilirubin concent r ation, to be used as an
aid for the managemen t of jaundice in newborn infant s. The
measur ements are taken au to matically when you place the in strument ’s
measuring probe against the forehea d or sternum of the inf ant and press
it gently; the measured value is then displayed.
The Jaundice Meter (JM-103) measures the yellowness of the
subcutaneous tissue in infants through the detection of the optical
density di fference at two wavelength s. It displays a measured value that
has been sho wn to correla te wit h ser um bili rubi n. The devic e is inten ded
for use in the h ospital to assist clinicians in monit or ing the sta tus of
infants for the deve lopment of hyperbil irubinemia. The device is not
intended a s a standalone for diagnosis of hyperbilirubinemia. It is to be
used in c onjunction with other clinical signs and laboratory
measurements. Infants whose Jaundice Meter (JM-103) test results are
indicative of hyperbiliru binemia are evalu ate d by their doctor(s) for
appropriate patient manag em ent. Bilirubin levels should be confirmed
by other methods (e.g. serum bilirubin) prior to treatment
determinations.
SPECIFICATIONS
Measuring Point
Measurements must be taken only on the infant’s forehead or sternum
where a suf fici ent am ount of b lood is ci rcula ted. A po ssibil it y exis ts th at
the bilirubin in the subcutaneous tissue may measure low for are as with
minimal blood flow or areas in which the subcutaneous tissue is subject
to keratiniz ation.
The measuring points for this device include the forehead and the
sternum of the infant. Although c orrelation with serum bilirubin was
observed for both forehe ad and ster num measurements, the clinical
studies performed with the Jaundice Meter (JM-103) show consis tently
better results with measurement s ta ken at the sternum versus the
forehead.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 1
Precocious Jaundice
Do not use this device on infants with precocious jaundice. If the re is a
possibility that the infant is suffering from precocious jaundice, as a
result of an incompatible blood type or hemolytic jaundice, it is
recommended that the total serum bilirubin be measured.
Phototherapy
WARNING:
Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion. Patient injury could occur.
Page 2 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Explanation of the Test
Measurin g 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) wavele ngth 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 minimiz ing the infl uence s of the melan in pigment and th e skin
maturity.
SPECIFICATIONS
When the measuring probe is pressed against the forehead or sternum of
the infant, the built-in xenon lamp flashes. The light fr om th e xenon
lamp passes thr ough the glass fiber and illuminates the skin. The light
scatters an d is ab so r b ed in th e sk in an d su b cu taneous tissue rep e at ed l y,
and then finall y returns to the sensor side of the glass fiber. Of the light
that returns, the part scattered from the shallow areas of the
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 pa th, and then
reaches it s corresponding photodiode.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 3
By calculating the difference in the optical densities, the pa rts that are
common to the epidermis and dermis are d educted, and as a re sult, the
differe nce in the optical densities between the two wavelength re gions
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 (JM-103) de vice software uses a correlation
coeff icient 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.
Use of the Device
Patient Population
The Jaundice Meter (JM-103) is indicated for use in neonatal patients
born >35 weeks gestati on who have not undergone transfusion or
photother apy treatment.
Page 2 - 4 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Averaging of Measurem ents
There was no significant difference between the averaged measurements
and the single measurement approaches in the largest study for sternum
measurements. The mean of three measure ments showed the highes t
degree of correlation (r=0.965), however, the difference was minimal
with a single measurement (r=0.963).
The advantages of using average measurements should be assessed at
each facility.
Action Levels
Each facility should deter mi ne their own action levels based on studies
of performance of the device on their population. Appropriate a ction
levels may vary depending on performance of the device, such as
precision or correlation with serum bilirubin, in the hands of the user.
Some factors that could affect performance of the device or appropriate
action levels include skin color, age, or measurement site. Careful
selection of ac tion levels should be made so that false negat ives do not
prevent appropriate follow up measures.
Calibration
There is no user calibration of this device. The system doe s include a
checker that me asure s the int ensi ty of l ight fro m the de vice to ensure t he
light output is within ran ge.
Processing of Measured Values
The Jaundice Meter (JM-103) determines the yellowne ss of the
subcutaneous tissue by measuring the difference in the optical densities
for light in the blue and green wavelengt h regions. The optical density
diffe rence has been shown to have a linear correlation with serum
bilirubi n concentration. T he device computes an estimated bilirubin
concentra tion based on this linear correlation and provides the val ue on
the display. The correla tion coefficient used in this computation was
derived from clinical data.
SPECIFICATIONS
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 5
Features
Controls, Indicators, and Connections
Controls, Indicators, and Connect ions
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 Ready lamp Illuminates to indicate that the J aundice Meter
is ready for the next measurement.
C Display Displays the measured value.
D Measuring prob e Takes the measurement when pres s ed against
the measuring point.
Page 2 - 6 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Name Function
E Charger section Connect the cha rger unit to the charger sec-
tion.
F Reset button Deletes the currently displayed measured
value and prepares for the next measurement.
When used with t he Power switch, the device
switches to Chec k Mo de and chang es the un it
of measurement.
G Str ap attachment area Is where the s trap attaches.
H Checker cover Open this c hecke r cove r to c heck the Ja undice
Meter.
I Charger lamp Illuminates t o indicate that the Jaundice Met er
is chargi n g.
J DC jack Connect the AC adapter to this jack.
K Charger jack Connect the main body to this jack.
L Checker Checks for the intensity of light output by tak-
ing measurements in Check Mode.
M Standard checker
For reference.
values
N DC plug Connect the charger’s DC jack to this.
O DC Plug (interna-
Connect the charger’s DC jack to this.
tional)
SPECIFICATIONS
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 7
Display
Name Function
A AVG Illuminates duri ng averaging measurement .
B Optical path indicator
(•)
C Value Displays the measured value.
D Unit of measur em ent Displays the unit of measurement in either
E Battery indicator When the battery power is low, the battery
When performing inspections with the
checker, • illuminates when the L-value
appears and extingui shes when the S-value
appears.
NOTE: When the measured value is greater
than 20 mg/dl, the displ ay shows “---” an d the
physician should be contacted.
milligrams per deciliter (mg/dL) or mi cromoles of solute per liter (µmol/L)
indicator blin ks. Ch ar ge the bat tery a s soo n as
possible (see “Charging the Battery” on page
4-1).
If only the battery indicato r lights, the battery
has run out. Go to “Charging the Battery” on
page 4-1.
If the power is on and the displ ay is blank, the
battery is completely exhausted. Go to
“Charging the Battery” on page 4-1.
Page 2 - 8 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Standard Features
• Jaundice Meter (JM-103)
• Charger unit (Model JM-A30) with a checker
• AC adapter (Model JM-A31)
SPECIFICATIONS
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 9
Specificat ions
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
RMSE
∗
Light source Pulse xen on arc lamp
Light source life 150000 measurements
Sensors Silicon phot odiodes
Power source Special Ni-MH ba ttery
Protectio n type and level Internally-powered instrument, BF-
Minimum number of
measur ements when fully charged
Operating temperature range 10°C (50°F) to 40°C (104°F)
Operating rela tive humidity range 30% to 95%
Storage temperature range -10°C (14°F) to 50°C (122°F)
Storage rela tive humidity range 30% to 95%
Dimensions 48 mm (1.9") wide x 15.5 cm (6.1")
Weight, including battery 150 g (5.3 oz)
AC adapter input for North America 120V, 50/60 Hz, 10 W
AC adapter input for
International use
AC adapter output 9V, 500 mA
± 1.5 mg/dL or ± 25.5 µmol/L
type
400 single measurements
high x 33 mm (1.3") deep
200V-240V, 50/60 Hz, 12.5VA
* This accuracy is based on the aggregate results from both clinical
study groups (n=613). Refer to Appendix A for a detai led descri ption of
results by clinical site, measurement loca tion, and patient
demographics.
Page 2 - 10 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Regulations, St a ndar ds, and Codes
In No rth Am e r ica
With respect to electrical shock, fire, and mechanical
hazards only, this instrument complies with UL
2601-1 and CAN/CSA C22.2 No. 601.1.
In Europe, this instr ument complies with EN60 601-1, EN60601-1-2,
and EN ISO13485, and EN ISO14971.
SPECIFICATIONS
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 11
NOTES:
Page 2 - 12 Jaundice Meter (Model JM-103) User Manual (usr070rb)
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 resul t in fire, personal injury, or
equipment damage.
SHOCK HAZARD:
Always plug the instrument into an AC outlet of the correctly rated
voltage and frequency. Fai lure 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 use a mobile telephone when using the Jaundice Meter. A
measurement error could occur.
CAUTION:
The Jaundice Meter interferes with Magnetic Resonance Imaging
(MRI) procedures. Inaccurate readings could occur.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 3 - 1
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.
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:
Do not use the instrument in direct sunlight. Equipment damage
could occur.
CAUTION:
The instrument has a built-in, non-replaceable battery. Do not
disassemble the instrument to replace the battery. To replace the
battery , contact your dealer or authorized Hill-Rom service center.
Failure to do so could result in equipment damage.
Page 3 - 2 Jaundice Meter (Model JM-103) User Manual (usr070rb)
Safety Tips
WARNING:
This instrument emits intense light to take its measurements.
Take measurements only at the forehead or sternum, and do not
press the measuring probe when it is directed toward the eyes.
Damage to the eyes could occur.
WARNING:
Before use, clean the measuring probe by wiping it with medicinal
alcohol. Failure to do so could result in the spread of infection or
infant inju r y.
WARNING:
The charger unit (JM-A30) and the AC adapter (JM-A31) are
solely designed for use with the Jaundice Meter (JM-103). Use
them only when chargin g the instrumen t. Using them to charge
other equipment could result in personal injury or equipment
damage.
WARNING:
Only facility-authorized personnel should troubleshoot the
Jaundice Meter. Troubl es hooting by unaut horized personnel
could result in personal injury or equipment damage.
WARNING:
Follow the product manufacturer’s instructions. Failure to do so
could result in personal injury or equipment damage.
WARNING:
Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion. Patient injury could occur.
SHOCK HAZARD:
Do not plug or unplug the AC power cord’s plug with wet hands.
Personal injury or equipment damage could occur.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 3 - 3
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