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CO NTENTS

1. Introduction.................................................................................................2
2. General instructions....................................................................................2
3. Specifications..............................................................................................2
4. Analyzer set.................................................................................................3
5. Precautions..................................................................................................4
6. The principle of operation and the designe of the device............................4
7. Preparation and the operating......................................................................7
8. Maintenance and operation checkout.........................................................11
9. Troubleshootings.......................................................................................12
10. Transportation and storage.......................................................................19
11. Acceptance data.......................................................................................20

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1. INTRODUCTION
1.1. This Manual provides operation and maintenance instructions for
the Photometrical Hyperbilirubinemia Analyzer PHA-02, hereinafter
referred to as BILITEST (the device).
1.2. BILITEST is a fully automated bichromatic photometer designed for
a non-invasive hyperbilirubinemia degree assessment in the newborn infants
by the measuring transcutaneous bilirubin index (TBI) in subcutaneous
tissues. Readings of BILITEST, are directly displayed on its display, and
given in units of TBI, which has the high correlation with the concurrent
laboratory values of the serum bilirubin concentration (SeBC).
2. GENERAL INSTRUCTIONS
2.1. Please, read this manual carefully before you start work with
BILITEST to ensure its proper operation. Before using BILITEST in medical
practice you should study carefully the recommendations for its clinical use,
given in Methodical recommendations "Diagnostics and the control of
newborns hiperbilirubinemia using non invasive transcutaneous photometric
analyzer " Bilitest " type PHA-02 and section 7.
2.2. Remove (pull out) the clear film (label To remove) blocking the
batteries contacts in the battery compartment.
2.3. To prevent BILITESTs failure during operation it is necessary to
observe the precautions, given in Section 5.
3. SPECIFICATIONS
3.1. Method of measurement reflectance bichromatic photometry.
3.2. Light source two white light-emitting diodes (LED).
3.3. Detector two photocell system.
3.4. Measuring range 2-58 (in units of TBI)
3.5. Optical inaccuracy - 10 percent. Imprecision (CV%) - 2
percent.
NOTES
1. Metrological characteristics have been verified by Russian Federation
State Committee for Standardisation and Metrology on the basis of
Reference Reading Checkers.
2. If BILITEST is in the correct working condition then the TBI values
measured on the Control Reading Checkers (RC1 and RC2) have to be

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within the limits, that are written in Section 11 (the same limits are printed
on the label inside the Carrying Case).
3.6. Correlation between TBI and laboratory values for SeBC - > 0.92.
3.7. Readout three digits liquid crystal display (LCD).
3.8. Measuring cycle time - ~2 seconds.
3.9. Power source 3 batteries of AA (or LR03) type.
3.10. The number of measuring cycles - > 30,000.
3.11. Weight (with batteries) 150 grams.
3.12. Dimension Width x Height x Depth 135x65x35 mm.
4. ANALYZER SET
4.1. The Photometrical Hyperbilirubinemia Analyzer PHA-02 Set
consists of the items listed in Table 1.
Table 1
Description
TECHNOMEDICA
Q-ty
Note
Code
pcs
Photometrical
TU 9443-002-11254896-2002
1
Hyperbilirubinemia
Analyzer
PHA-02
(BILITEST)
Control Reading
DGVI.943119.001
1
Checker (RC1)
Control Reading
DGVI.943119.002
1
Checker (RC2)
Carrying Case
DGVI.943129.001
1
Battery AAA (LR03)
3
Manual
DGVI.941416.001 M
1
Methodical
recommendations

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5. PRECAUTIONS
5.1. BILITEST meets the IEC requirements imposed upon the devices
with built-in power source.
5.2. Never attempt to disassemble the device. Non-expert service of the
device may damage it.
5.3. After BILITEST being exposed to cold, it should be kept in its
Carrying Case for about four hours at room temperature before use.
5.4. Do not leave BILITEST near heat sources, or on direct sunlight,
excessive dust or mechanical shock.
5.5. Do not drop, knock or shake BILITEST. Rough handling can break
internal parts of the device.
6. THE PRINCIPLE OF OPERATION AND THE DESIGNE
OF THE DEVICE
Transcutaneus bilirubinometry is based on the phenomenon of a
diffusion of a bilirubin from a blood into surrounding tissue (derma). The
increasing of bilirubin concentration in blood results in increasing of
bilirubin concentration in derma and, on the contrary, decreasing of bilirubin
concentration in blood (for example, at a hemotransfusion) results in return
movement of a bilirubin from derma into a blood till between these two
systems there will come balance.
The bilirubinometer is the optical electron device, which consists of
the trochlea mobile lightguide head, a control panel and a battery
compartment for three elements of a feed on 1,5 V direct current (such as
or LR03). Appearance of the device is in fig. 1.

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Fig. 1.
The trochlea mobile lightguide head consists of an analog display
and an optical part. On the analog display the amplifier of a photocurrent,
the stabilizer of a current of light-emitting diodes, the device of analogdigital transformation are posed. In an optical part two light-emitting diodes,
two interference light filters "dark blue" and "green", and also three light
guides are fixed: two of them for transmitting a light stream from lightemitting diodes to a skin and the third - to return light stream transmitting
on photo diodes, diffused by skin. On the control panel the microcontroller
and the digital device indications are placed.
The device measures the light intensity reflected by hypodermic
tissues, in two ranges of wavelengths. Using and the measured values the
microcontroller calculates the transcutaneus bilirubin index (TBI).
Calculation is made under the formula received in the experimental way and
giving the maximal correlation between bilirubin in serum and parameter
TBI. TBI is complex function of the accepted signals and factors C1, C2, C3,
C4. Values of these factors are established by manufacturer and can be
changed (checked up) by pressing of buttons L and R according to paragraph
9.3 section 9 Probable malfunctions and ways of repairing of this manual.
After pressing the head of the device the following processes begin:
1.The lightguide head is a little planged inside of the device. The
cycle of gauging is started. The device produces a sound signal. The light
stream, alternately emanated by light-emitting diodes, is distributed on

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transmitting light guides and gets in a so-called zone of contact - on an


examined site of a dermal surface.
2. Partially the light stream is re-reflected (dissipated) in the back
direction, at the same time there is its absorption by bilirubin contained in
hypodermic tissues and by haemoglobin in the special zone of a spectrum.
The reflected (dispersed in the opposite direction) and changed its spectral
structure light stream passes through a reception light guide. The reception
light guide has the Y-shaped form and "dark blue" and "green" interference
light filters are fixed on its bifurcated ends.
3. The light stream, passed through light filters, gets to photodiodes.
On photodiodes four signals used at calculation of value TBI are created.
4. At the end of gauging (a sound signal stops) the symbol "-O-"
appears on a display and then digital value TBI is displayed. Value of TBI
remains on the display during 20-30 seconds.

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7. PREPARATION AND THE OPERATING


7.1. The device should be in an instrument-case if gauging are not
carried out. Thus the lightguide head adjoins to a white rectangular and the
device periodically performs calibration.
At removal the device from a case it is ready to gauging in 10
seconds.
7.2. The device serviceability control is carryed out over control light
filters (RC), fixed in a case.
The check up on RC1 and RC2 is carried out at the installation of
the device, then periodically (once a month) or in case of doubt as a result of
gauging TBI. For the check of serviceability of the device over RC1 and
RC2 it is necessary:
1) Take the device out from the case, and put the case on a level
horizontal surface (table). Surface of RC should be clean. If it is necessary
wipe surface RC with a soft dry fabric (gauze, lawn);
2) Not pressing the device, put it so that the surface of lightguiding
head end face densely adjoined to a surface of control light filter RC1 and
was perpendicular to it ;
ATTENTION: if during a measuring cycle the device will be
inclined under an angle to plane RC results of gauging can be incorrect.
3) Slightly press the device, not inclining it, until occurrence of a
sound signal. Thus on a display there will be displayed at first - - - , next
"-0-", then "number". After ending of a sound signal stop pressing
("number" will be kept on a display about 20-30 seconds). If after the
ending of pressing a display it is displayed and kept - - - , it means, that
the device has not made gauging and it is necessary to carry out gauging on
RC for a second time.
If during a measuring cycle on a display instead of -0- other
symbol was displayed it is necessary to check up installation of factors
according to paragraph 9.3. of the manual.
Measured on RC values of serviceable device should not exceed the
values resulted in section 11 "Acceptance certificate" of the manual (the
same values are specified on a label pasted in a case to the device near RC).
In the same way carry out the gauging on control light filter RC2.
The note: it is not recommended to carry out the gauging near to
bright sources of illumination.
If instrument readings on RC do not meet required ones:
1) Repeat gauging, taking care of perpendicularity of the device to
RC
2) Check up the correctness of calibration.

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Check up the correctness of calibration: get the device from a


case, wait for 10 seconds and again insert into a case completely and
without skews. If as a result of gauging on a one of the following digits is
displayed: 0,-0, 1,-1 - that calibration is correct.
In case of occurrence of other digits - it is necessary to make
calibration of the device.
Calibration of the device: get the device from a case, wait for 10
seconds and again insert it into a case completely and without skews, thus
the lightguide head adjoins to the white rectangular and the device utters a
sound signal. If at installation of the device into the case the sound signal is
absent, it is necessary to get the device from the case, put forward slightly
the mobile head from the case of the device, and then insert the device into
the case once more. Wait the second sound signal (approximately in 20-30
sec.), then the display will go out. Calibration is complete.
3) If you were convinced that the device was calibrated correctly and
during gauging on RC its perpendicularity to RC was provided, but the
device shows values not meeting paragraph 11 of the manual, clear surfaces
of RC and of the optical head and check up correctness of factors C1, C2, C3,
C4 installation (paragraph 9.3 of section 9 Probable malfunctions and ways
of their elimination). Then repeat gauging. If after that the values measured
on RC again do not correspond to paragraph 11 of the manual it is necessary
to address to the manufacturer.
Gauging of TBI
7.3. The general references:
It is necessary to make three repeated measurements successively for
rising an accuracy of TBI definition, each time shifting the device on a few
millimeters along a forehead of the child. In case of difference in results
choose average, having rejected the least and the greatest ones.
At carrying out the gauging it is necessary to mean that results will
be doubtful if there are hypodermic haematomas or vascular stain in the area
of gauging (for example, after carrying out infusional therapies). In this case
it is more preferable to carry out gauging TBI on the top part of a breast
bone.
In more detail about a choice of a site of a dermal surface for
gauging TBI it is written in Methodical recommendations "Diagnostics and
the control of newborns hiperbilirubinemia using non invasive
transcutaneous photometric analyzer " Bilitest " type PHA-02.
7.4. It is necessary to disinfect the device before definition TBI at
each patient: holding the device with the head downwards, not pressing on
the lightguide head wipe its end face with soft fabric (a gauze, lawn) or a
cotton tampon moistened in alcohol-rectificate. It is necessary to dry an end

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face after processing and to wipe with a soft dry fabric (a gauze, lawn). Do
not allow course of alcohol inside the device.
7.5. For gauging TBI at newborn it is necessary to approach closely
an end face of the mobile head of the device perpendicularly to the chosen
site of a dermal surface and to press the device, smoothly enlarging effort,
till a sound signal. Hold the device on till the ending of a sound signal with
duration of about 1-3 seconds, and then take off effort of pressing.
Occurrence at a display a symbol - - - instead of digital value means that
the mobile head was taken off before the ending of a sound signal and then
the gauging should be repeated. The end of a sound signal indicates the
ending of gauging and occurrence of result on a digital display.
At first the symbol -- is displayed and then digital value of TBI
which remains on a display for 20-30 sec. It is recommended to carry out
gauging for 3 times, each time shifting the device on a few millimeters. In
case of difference of results choose average, having rejected the least and
the greatest one.
7.6. Upon the end of gauging it is necessary to make disinfection of
the device, and then to insert it into the case completely and without skews.
The device with fixed batteries does not demand turning on and off.
The NOTE: If at installation in the case the device shows the
numbers distinct from: 0,-0, 1,-1 on white color standard take out the device
from a case not waiting its re-calibration and insert into a case again. If as a
result of gauging you see on a display again not: 0,-0, 1,-1, leave the device
in a case for 3 minutes for its calibration. In this case it is necessary to cast
doubt on the received results and to repeat gauging TBI.

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7.7. The brief order of operations at gauging of transcutaneus


bilirubin index (TBI) on the device is resulted in tab. 3.
Table 3.
Operation
1. Take the device out of the case. The device with fixed batteries does not
demand turning on and is ready to work in 10 seconds after withdrawing
from a case.
2. Wipe an end face of the lightguide head with soft clean fabric (a gauze,
lawn) or a cotton plug moistened in alcohol-rectificate. Then it is necessary
to wipe it with a soft clean fabric (a gauze, lawn) and to dry the end face
after processing. Processing (wiping) should be carried out before gauging
TBI at each patient. Gauging TBI can be carried out only after alcohol
completely will dry up.
3. Measure TBI at newborn. For this purpose approach closely the end face
of the mobile head of the device perpendicularly to the chosen site of a
dermal surface and press the device, smoothly enlarging effort before a
sound signal. Hold on and do not move the device before the ending of a
sound signal (1-3 ) after which remove the device from a skin. The result of
gauging TBI is displayed on a digital display. Occurrence on a display of a
symbol - - - instead of digital value means that the mobile head was not
adjoined before the ending of a sound signal and in this case gauging should
be repeated. The result of gauging is held on a display for about 30 second,
then the device switches to standby mode. Repeated gauging can be
carried out every other second on the nearest next sites of a skin. Carry out 3
measurements and choose average result.
4. Measure the TBI at the next patient according to paragraph 2 and 3 of the
algorithm.
5. After the measurement is completed process the head and put the device
into the case. The device does not require turning off.

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8. MAINTENANCE AND OPERATION CHECKOUT


8.1. BILITEST's disinfection should be made once a week. The external
surfaces are cleaned with a tampon moistened by 3 percent solution of
hydrogen peroxide with 0.5 percent solution of detergent at temperature not
less then 18C.
8.2. If BILITEST is not be used for a long period of time, the batteries
should be removed.
8.3. To ensure the correct performance of BILITEST regular performance
verification (check) is required.
8.4. The checking of BILITEST's working condition should be made by
the measuring RC1 and RC2 colour Control Reading Checkers.
NOTES
1. If BILITEST is in the correct working condition then the TBI values
which are measured on the Control Reading Checkers have to be within the
limits which are written in Section 11 (the same limits are printed on the
label sticked inside the Carrying Case).
2. BILITEST is verified (checked) by medical staff while putting into
operation and in course of its operation. The manufacturer recommends to
make performance verification before and after each run of measurements.

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9. TROUBLESHOOTINGS
9.1. Probable malfunctions of the device and ways of their repairing
are resulted in tab. 4.
Table 4.
The
name
of The probable reason
A way of repairing
malfunction
Absence of indication, There is no power Replace batteries with
sound
signal
and because
of
faulty new ones according to
flashes of light in the batteries.
the item 9.2 of the
optical head at gauging
manual, and then
or while pressing the
calibrate the device
optical head.
according to item 7.2.
of the manual.
Bad contact in the Clean contacts of the
battery compartment
batteries
A symbol UUU* is Calibration of the device Make calibration of
indicated on a display; is brought down. The the device, according
at the same time optical head of the to item 7.2. of the
during pressing the device was pressed more manual
optical head the device then 1 minute when the
does not make gauging device was not in a case.
(there are no light Batteries are unloaded.
Insert new batteries
flashes and a sound
according to the item
signal)
9.2 of the manual, and
then calibrate the
device according to
item 7.2. of the
manual.
Bad contact in the Clean contacts of the
battery compartment
batteries.
* Symbol UUU appears in the device during calibration if a level of a
light signal is insufficient. In this case the measuring cycle of the device is
blocked. Symbol UUU disappears at the following calibration on a white
color standart, if a light signal is normal or at battery replacement.
The indications do not During the gauging the Put a case with the
meet
the
values device has been inclined device on an level
admitted at carrying under an angle to plane horizontal
surface,
out of gauging on RC RC.
and then carry out
and specified in item
gauging on RC on
11 of the manual
item 7.2. of the
manual.

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Wrong calibration

Make calibration of
the device on item
7.2. of the manual.
The end face of the Wipe an end face
lightguide
head
or lightguide head or
surface RC is polluted.
surface RC on item
7.2.of the manual.
The numerical factors Check up and if it is
setted in the device does required
enter
not not correspond to the corresponding factors
values specified in item on Section 9.3. of the
11 of the manual.
manual
At gauging TBI a Factor C1 is entered Check up and if it is
symbol
-H-
is incorrectly
required
reinstall
displayed instead of
factors on item 9.3. of
-0-
the manual
At gauging TBI a The
sequence
of Enter (check up)
symbol -_-, -U- or installation (check of numerical factors in
-E- is displayed numerical factors) is strict sequence on
instead of -0-
broken. The last entered item 9.3. of the
was not C4.
manual.
The display indicates A mistake of data Enter (check up)
the symbol .
reading
from
non- again
numerical
volatile memory.
factors on paragraph
9.3 and calibrate the
device on item 7.2. of
the manual.
In other cases servicing is made by qualified personnel of the
Manufacturing Works.

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9.2. Replacement of batteries


Replacement of batteries should be made when the symbol "UUU"
is displayed during the gauging.
The battery compartment is on the back panel of the device under a
cover. Remove a cover and take out elements of a feed, insert new such as
or LR03, keeping polarity specified at the bottom of a battery
compartment.
After inserting new batteries into the device first will be displayed
the alphanumeric code, meaning the version of the program setup in the
device, and then - -. In 1 second the display fades.
Calibrate the device on item 7.2 of a manual.
ATTENTION! You should be sure that your batteries are of high
quality. The power on three consistently paired batteries should be not less
4V at a current 20 . Therefore the use of re-charging accumulators is not
supposed. It is not recommended to use various batteries or old ones
together with new.
9.3. Installation (check) of numerical factors
The buttons L and R under a cover of battery compartment serve for
installation (check) of numerical factors.
Numerical coefficients are set on the manufacture and written in
Section 11.
ATTENTION! The procedure of installation (check) of factors
always should be finished with installation of factor C4 (even if it is not
required to change it). It is related to that the device "remembers" a mode of
display corresponding to last entered factor. Thus at the subsequent
measurements the corresponding symbol - _ - either -U- or -E- and
the corresponding service data will be displayed.
To install or check the factors it is necessary to get the device from a
case and take off a cover of a battery compartment, slightly pressing
corrugated marks of an arrow in a direction specified by an arrow, and
shifting a cover from the case. Then carry out operations on the sequence
described in Tab. 5.

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Table 4.
Checking (setting) numerical coefficients
Operation
What is displayed
1. To check (set) C1 value press and
hold L button. The symbol -E- will be
displayed. If the symbol -_-, -U- or -H-
-Eis displayed then press and release repeatedly L
button until the symbol -E- is displayed.

2. Press R button and release both


buttons simultaneously. C1 value will be
displayed (e.g. 125).
Note: The correct C1 value is written in
Section 12, and can differ from what is shown
in this table.

15

141

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Table 4 cont.
3. If C1 value is correct then just wait
(approx. 5 sec.) until BILITEST saves this
value. If C1 value is not correct, then set
correct C1 value while it is displayed (approx. 5
sec.). To increase C1 value press and release R
button. To decrease C1 value press and release
L button.
To set a desired value quicker, press and hold R
or L button approx. 5 sec. A desired value will
change quicker while R or L button is pressed.
When on the display correct value 1 will
appear, wait for 5 seconds while BILITEST will
remember this value.
4. To check (set) C2 value press and
hold L button. The symbol -_- will be
displayed. If the symbol -E-, -U- or -H-
is displayed then press and release repeatedly L
button until the symbol -_- is displayed.

BILITESTs display
will be clear and a
short sound will be
heard

-_-

5. Press R button and release both


buttons simultaneously. C2 value will be
displayed (e.g. 26).
Note: The correct C2 value is written in
Section 12, and can differ from what is shown
in this table.

16

26

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6. Repeat the operations as written in


the item 3 of the algorithm only for C2 value.
7. To check (set) C3 value press and
hold L button. The symbol -U- will be
displayed. If the symbol -E-, -_- or -H- is
displayed then press and release repeatedly L
button until the symbol -U- is displayed.

Table 4 cont.
BILITESTs display
will be clear and a
short sound will be
heard

-U-

8. Press R button and release both


buttons simultaneously. C3 value will be
displayed (e.g. 154).
Note: The correct C3 value is written in
Section 12, and can differ from what is shown
in this table.

9. Repeat the operations as written in


the item 3 of the algorithm only for C3 value.

17

154

BILITESTs display
will be clear and a
short sound will be
heard

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Table 4 cont.
10. To check (set) C4 value press and
hold L button. The symbol -H- will be
displayed. If the symbol -E-, -U- or -_- is
displayed then press and release repeatedly L
button until the symbol -H- is displayed.

-H-

11. Press R button and release both


buttons simultaneously. C4 value will be
displayed (e.g. 114).
Note: The correct C4 value is written in
Section 12, and can differ from what is shown
in this table.

12. Repeat the operations as written in


the item 3 of the algorithm only for C4 value.

114

BILITESTs display
will be clear and a
short sound will be
heard

Symbols output sequence and corresponding numerical coefficients


is given in Table5.
Table 5.
The corresponding
The symbol which is displayed if to press L button
numerical
coefficient
-E-
C1 =
-_-
C2 =
-U-
C3 =
-H-
C4 =

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10. TRANSPORTATION AND STORAGE


10.1. BILITEST is kept in the Carrying Case. The storage conditions are
as follows: warm and ventilated warehouses, conditioned storehouses at
temperature 5 C-40 C and humidity - up to 80 percent at temperature
25C. Do not keep the device:

in an area exposed to direct sunlight;

near a heater;

in a high humidity area.


10.2. Before storage or transportation the batteries should be removed.
10.3. In case of exposing the device to low temperatures (-40 C-0 C)
during transportation it should not be used until it is warmed to room
temperature, not less than 4 hours.

Dear Hector. C2=26, C3=154, C4=11, C1 must to


be odd number. For excample C1=83. I will try to
learn the value of C1 for your Bilitest.

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11. ACCEPTANCE DATA


Photometrical Hyperbilirubinemia Analyzer PHA-02,
serial
number
____________________ corresponds to the technical
specification TU 9443-002-11254896-2002, to the documentation set
DGVI.941416.001-01 and is ready to use.
The corresponding numerical
coefficient
C1 =
C2 =
C3 =
C4 =

The symbol which is displayed


-E-
-_-
-U-
-H-
Scale parameter M = ________.
Program version ______.
The values of RC:
RC1 =

+2,-1

RC2 =

+2

Production date: ______ ______________ 200 __.


From technical control department
/__________________ /

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