Beruflich Dokumente
Kultur Dokumente
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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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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10
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11
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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.
12
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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.
13
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14
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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.
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
-_-
16
26
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Table 4 cont.
BILITESTs display
will be clear and a
short sound will be
heard
-U-
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-
114
BILITESTs display
will be clear and a
short sound will be
heard
18
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near a heater;
19
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+2,-1
RC2 =
+2
20