CareFusion MicroDL Operating Manual
MicroDL
Operating Manual Bedienungsanleitung Руководство пользователя -
English
Deutsch
Русский
1
Contents
I. Introduction – English........................................................ 3
Package contents .............................................................. 4
Configuring the MicroDL ..................................................... 5
Configuring the MicroDL with SPCS.....................................27
Battery Management ........................................................28
Calibration Check .............................................................29
Cleaning the Transducer....................................................30
Consumables/ Supporting products ....................................31
Training ..........................................................................31
Specification of the MicroDL...............................................33
II. Introduction – CareFusion USA ..........................................35
Package contents .............................................................36
Configuring the MicroDL ....................................................38
Configuring the MicroDL with SPCS.....................................61
Battery Management ........................................................63
Calibration Check .............................................................63
Cleaning the Transducer....................................................65
Specification of the MicroDL...............................................66
III. Einleitung – Deutsch.........................................................68
Packungsinhalt.................................................................69
Konfigurierung des MicroDL ...............................................71
Konfigurierung des MicroDL mit SPCS .................................96
Batteriemanagement ........................................................97
Überprüfung der Kalibrierung.............................................98
Reinigung des Messwertwandlers .....................................100
Spezifikationen des MicroDL ............................................101
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IV. Введение - Русский.......................................................103
Принадлежности ...........................................................104
Конфигурация MicroDL ..................................................106
Конфигурация MicroDL с помощью программы SPCS ........129
Работа батареи .............................................................131
Проверка калибровки....................................................131
Очистка датчика ...........................................................132
Технические данные и спецификации ............................134
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MicroDL
Operating manual
I.Introduction - English
The MicroDL spirometer is a compact, battery operated, and fully
portable data recording spirometer designed to collect spirometry
data, expiratory Flow/Volume and Volume/Time curves.
The MicroDL can be configured for use with a single patient for
detailed monitoring over a period or for collecting spirometry data
from a number of patients.
Alternatively, the data may be uploaded to a PC running the fully
featured Spirometry PC Software (SPCS). Once uploaded, the data
may be viewed individually or as a trend graph and the Flow/Volume
loop of any individual point examined. SPCS may also be used to
perform live spirometry tests and show the expiratory Flow/Volume
loop, Volume/Time curve and child incentive displays.
In single patient mode the user can perform a spirometry test. After
each spirometry manoeuvre the results are displayed together with
a ‘traffic light’ indication of their performance as an aid to asthma
management. The levels that activate the red, amber and green
lights, as a percentage of the predicted value, can be selected when
the unit is configured. Alternatively, the activation may be based on
the patient’s personal best values when the unit is configured using
the SPCS software.
3
In multiple patient mode spirometry results can be collected from up
to 200 patients. In this mode the ‘traffic light’ activation is based
upon the patient’s predicted values.
The spirometer uses the CareFusion Digital Volume Transducer, an
extremely stable form of volume transducer, which measures
expired air directly at B.T.P.S (Body Temperature and Pressure with
Saturated water vapour) thus avoiding the inaccuracies of
temperature corrections. This transducer is insensitive to the effects
of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Package contents
The MicroDL is packaged in a convenient carrying case and comes
complete with the following items (Fig.1):
1. MicroDL microcomputer unit
2. CareFusion Digital Volume Transducer
3. PP3 alkaline battery
4. Serial Cable together with disposable cardboard
mouthpieces.
4
MicroDL
Fig.1
2
on
enter
of
4
3
1
Configuring the MicroDL
The MicroDL must be configured for single patient (asthma
management) or multiple patient use. Multiple patient use is
configured by hand on the instrument itself and single patient use
may be configured either by hand or more conveniently by the SPCS
software provided (see SPCS installation and operation).
5
When configuring for single patient mode a patient identifier must
be entered. This number will be used to identify data when printing
or uploading results. The age, height and sex of the patient
together with any ethnic correction must also be entered. This data
is used to calculate the predicted values for FEV1, FVC, PEF, and
FEV1/FVC. The ethnic correction reduces the predicted values of the
volume measurements by the percentage entered. Finally, the
levels at which the amber and red warning lights are activated are
entered.
These levels are expressed as a percentage of the predicted values
when the unit is configured by hand but the patient’s personal best
values may be used when the unit is configured using SPCS.
When using the MicroDL in multiple patient mode the patient details
are entered each time the unit is turned on. Therefore, when
configuring the unit for multiple patient use, only the warning light
levels are entered.
To configure the unit, depress the off key, turn the unit on and
release the off key. If there is data currently stored in the unit then
the number of records displayed:
Configuring the unit will delete these records so if the stored data is
required turn the unit off and print or upload the data using SPCS
(see Printing Stored Records and Uploading Results).
To continue with configuration and delete the data, press ‘enter’ and
the following will be displayed:
6
The 1 displayed indicates that the unit is set to single patient mode.
By using the up or down key, as indicated by the flashing arrows,
multiple patient mode may be selected when the display will change
to:
Once the required configuration is obtained, press ‘enter’.
If multiple patient mode has been selected the amber light will flash
and the display will change to:
%
Use the up and down keys to select the level of results below which
will produce an amber warning light when the user performs a
spirometry manoeuvre. This level is expressed as a percentage of
the predicted value. Please note that the default values displayed
may vary from those shown in this manual as the MicroDL will
automatically update the default values to the last actual values
used.
After pressing ‘enter’, the red light will flash and the display will
change to:
7
%
Use the up and down keys to select the required percentage of
predicted value which will produce a red warning light when the user
performs a spirometry manoeuvre less than the set value.
When the required level has been selected press ‘enter’ and the
display will change to:
The unit is now configured for multiple patient use and will
automatically turn off.
The most convenient way to configure the unit for a single patient is
to use the SPCS software provided. SPCS allows the user to
configure several options that are not available when the unit is
configured by hand.
These include:
Personal best values can be entered as a basis for the warning light
operation.
A simple operating procedure, for use by the patient, can be printed.
The results to be displayed can be selected.
However, the unit may be configured by hand in the following
manner.
8
Turn the unit on with the ‘off’ key depressed as described above and
select single patient mode by pressing ‘enter’ when the display
shows:
The display will then change to:
Use the up and down keys to select a patient number.
This number can be set using the ‘up’ and ‘down’ keys anywhere in
the range 1 to 1999 and will be used to identify data when printing
or uploading results. When the required number is displayed press
‘enter’ and the display will change to:
The flashing symbol represents a male patient and using the up or
down key will change the display to indicate a female patient:
9
When the correct selection has been made press ‘enter’ and the
display will change to:
yr
Adjust the patients age using the up and down keys and press
‘enter’. The display will change to:
Enter the patients height, in centimetres, using the up and down
keys and press ‘enter’.
The display will change to:
%
Adjust the ethnic correction using the up and down keys. The
display shows the percentage reduction of volumetric predicted
values to be applied for the patient. Press ‘enter’ when the required
correction has been selected. The levels for the amber and red
warning lights should now be set as described above in the
description of multiple patient configuration.
10
Spirometry Operation (Single patient use)
When performing a spirometry test the user should be instructed to
insert a disposable or clean reusable, mouthpiece into the
mouthpiece holder of the spirometer.
The unit is then turned on, the current time will be displayed briefly,
and the three lights will be illuminated before the display changes
to:
The patient should then inhale as deeply as possible, seal their lips
around the mouthpiece and exhale as hard and as fast as possible
until no more air can be exhaled. The spirometry results are then
displayed:
PEF
The first result shown is Peak Expiratory Flow (PEF). The arrows
indicate that the up and down keys may be used to scroll through
the other results of the test. These include FEV1, FVC, FEV1/FVC
(shown as FEV1 FVC), followed by the percentage of predicted value
for all of the above.
Note: when the unit is configured with SPCS software the displayed
results can be limited to only those that the patient can usefully
interpret, for example, the unit can be configured to display only PEF
and the percent predicted PEF. However, regardless of the
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measurements displayed, all measurements (including expiratory
Flow/Volume and Volume/Time data) will be recorded.
In addition, the MicroDL can be configured with PEF displayed in
units of Litres/min or Litres/sec.
As well as the spirometry results, warning lights will be displayed.
The lights are based on a percentage of the predicted value or
personal best values.
Note: personal best values can only be used when the unit is
configured using SPCS software.
The percentage level below which the warning lights illuminate can
be configured using SPCS software or when configuring the unit by
hand. The warnings lights will vary according to the spirometry
parameter displayed. However, if a lower level was present on one
of the other parameters then the lower level light will flash until the
display is scrolled to that parameter.
For example, if the unit is configured to display PEF, FEV1, and FVC,
then the patient will see the following displays when scrolling
through the results after a manoeuvre with good peak flow but a
poor FEV1 and very poor FVC:
PEF
on
off
enter
FE V
1
enter
FV C
on
off
on
off
enter
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After completing a spirometry manoeuvre the user may press ‘enter’
to repeat or off to finish testing. After completing a sequence of
tests, the best result will be stored. The definition of best is
selected using
best FEV1 +FVC. If the unit is turned off after performing a
manoeuvre, and then used again within five minutes, then only the
best result within the period will be saved.
SPCS and may be best FEV1, best FVC, best PEF, or
Spirometry Operation (Multiple patient use)
When performing a spirometry test the user should be instructed to
insert a disposable or clean reusable, mouthpiece into the
mouthpiece holder of the spirometer.
The unit is then turned on, the current time will be displayed briefly,
and the three lights will be illuminated before the display changes
to:
Use the up and down keys to select a patient number. This number
can be set, using the up and down keys, anywhere in the range 1 to
1999 and will be used to identify data when printing or uploading
results.
When the required number is displayed press ‘enter’ and the display
will change to:
13
The flashing symbol represents a male patient and using the up key
will change the display to indicate a female patient:
Pressing the up key again will remove the patient symbol:
This indicates that predicted values are not required and the unit will
not request the patient’s details. Please note that if this option is
selected then the warning lights will not be operational.
If male or female predicted values have been selected then the
display will change to:
yr
Select the patients age using the up and down keys and press
‘enter’. The display will change to:
14
Enter the patients height, in centimetres, using the up and down
keys and press ‘enter’. The display will change to:
%
Adjust the ethnic correction using the up and down keys. The
display shows the percentage drop of volumetric predicted values to
be applied for the patient. Press ‘enter’ when the required
correction has been selected.
Note: the initial patient number displayed and the default patient
details will be the same as the last one used. This is to facilitate
quick entry of details when performing a repeat test on the same
patient. If a new patient is to be tested then select a different
patient number.
After the patient details have been entered, the display will change
to:
Insert a disposable or clean reusable, mouthpiece into the
mouthpiece holder of the spirometer.
Instruct the patient to inhale as deeply as possible, seal their lips
around the mouthpiece and exhale as hard and as fast as possible
until no more air can be exhaled.
The spirometry results are then displayed:
15
PEF
The first result shown is Peak Expiratory Flow (PEF). The arrows
indicate that the up and down keys may be used to scroll through
the other results of the test.
These include FEV1, FVC, FEV1/FVC (shown as FEV1 FVC), followed
by the percentage of predicted value for all of the above.
Note: if the unit has been previously configured with SPCS, the
displayed results will be limited to only those previously set.
However, regardless of the measurements displayed, all
measurements (including expiratory Flow/Volume and Volume/Time
data) will be recorded.
As well as the spirometry results, warning lights will also be
displayed as described in the section ’Spirometry Operation (Single
patient use)’. However, in the case of multiple patient use, the light
activation is based upon the percentage of the predicted value as
personal best values cannot be entered.
After completing a spirometry manoeuvre the user may press ‘enter’
to repeat or ‘off’ to finish testing. After completing a sequence of
tests, the best result will be stored. The definition of best is
selected using SPCS
best FEV1+FVC. When off is pressed, the user has the option to
obtain a printout of the results.
The display will change to:
and may be best FEV1, best FVC, best PEF, or
16
If a printout is not required, press ‘off’ again and the unit stores the
results, date and time stamped, and turns off. If a printout is
required then connect the serial to parallel converter to the parallel
input socket on the printer. Connect the jack plug to the socket on
the side of the MicroDL and turn the printer on.
NOTE: Keep the printer out of reach of the patient when connected
to the MicroDL.
Press ‘enter’ on the MicroDL to obtain the following report:
MicroDL FULL REPORT
Patient Name:______________________________________
Test: 1 Date: 12/11/97 Time: 0802
ID: 6 Sex: Male Age: 19
Height: 190 cm Ethnic Correction: 0%
Parameter Result %Pred Pred Min Max Units
FEV1 3.71 74 4.95 4.11 5.79 L
FVC 4.61 77 5.95 4.95 6.95 L
PEF 9.67 90 10.74 8.75 12.73 L/S
FEV1%FVC 80 97 82 70 94 %
F50 4.15 68 6.07 3.90 8.24 L/S
F25 1.36 45 2.96 1.68 4.24 L/S
MEF 5.45 102 5.31 3.60 7.20 L/S
FET 4.66 S
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Flow/Volume Volume/Time
8L
RESULT
PREDICTED
FEV1
12
10
8
6
6
4
RESULT
PREDICTED
4
2
S
/
L
1
2 3 4
5 6 7 8
2
1
2 3 54 6 7 8
Normal Values: ECCS (adult); Zapletal, Solymar, Cogswell (child)
Results at BTPS
Technician: ______________ Physician: _______________
The first line gives the MicroDL version number and type of report (a
summary report of all data stored is also available – see Printing
Stored Results).
Subsequent lines give the test number (the tests are numbered
sequentially as they are stored), date and time of test, and patient
details.
This is followed by the test results presented with the percentage of
the predicted value, the predicted value, the predicted minimum and
maximum, and the unit of measurement.
The expiratory Flow/Volume and Volume/Time curves are also
shown overlaid with the predicted curves and FEV1 marker on the
Flow/Volume curve.
18
To obtain subsequent copies of the report press ‘enter’. When all
Singlerecord
the required printouts have been obtained press ‘off’ and the unit
will turn off.
If the unit is turned off after performing a manoeuvre, and then used
again within five minutes, then only the best result within the period
will be saved.
Printing Stored Records
There are five printing options for the stored results. To assist the
selection of the required option a system of icons will appear on the
display when the unit is set to printing mode:
Summaryreport
Spirometryreport
Allrecords
Allrecordssincelastprintout
If one page appears, then a single record has been selected
If two pages appear, then only records since the last printout will be
printed.
If three pages appear, then all stored records will be printed.
If the front page shows only lines of text then a summary report has
been selected.
If the Flow/Volume symbol appears, then a spirometry report has
been selected.
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.
Depress the up key, turn the unit on and release the up key after a
few seconds. The display will indicate the type of report to be
printed and the number of pages that will be used.
Use the up key to select the type of printout required.
The following examples assume that the unit is configured in single
patient mode.
Option 1 – summary report of all records
After turning the MicroDL on with the up key depressed the following
will be displayed:
This display is indicating that a summary report of all stored results
has been selected and that the printout will use two sheets of paper.
If this option is required then press ‘enter’ and the display will
change to:
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The following printout of spirometry results will be obtained:
MicroDL SUMMARY REPORT
Test ID Date Time FEV1 FVC PEF
----------------------------------------------------------------------------
1 6 10/09/97 10:56 2.97(86%) 3.25(78%) 7.49(87%)
2 6 11/09/97 11:32 2.74(79%) 3.12(75%) 6.45(75%)
3 6 12/09/97 09:58 3.14(91%) 3.53(85%) 8.37(97%)
‘’ ‘’ ‘’ ‘’ ‘’ ‘’ ‘’
‘’ ‘’ ‘’ ‘’ ‘’ ‘’ ‘’
‘’ ‘’ ‘’ ‘’ ‘’ ‘’ ‘’
Values in brackets are percentage of best value.
Technician: ____________ Physician: ______________
The summary report gives the date, time, FEV1, FVC, and PEF
together with the percentage of best value in brackets. The tests
are sequentially numbered and this can be used to select a
particular test for more detailed investigation by selecting a full
report using printing option 2. At any time during printing pressing
‘off’ will terminate the printing. Should the printer fail to operate
correctly then turn off both the printer and the MicroDL unit, check
all connections, and try again.
Option 2 – full spirometry report of one record
After turning the MicroDL on with the up key depressed, use the up
key again to obtain printing option 2. The display will show:
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This option is used to select a full report, including Flow/Volume and
Volume/Time curves, on one stored result. The ‘1’ indicates that one
sheet of paper will be used.
Press ‘enter’ if this option is required and the display will change to:
The tests are numbered sequentially as they are stored and the
number displayed represents the last test recorded.
Use the down key to select the required test and then press ‘enter’.
The display will change to:
The following printout of spirometry results will be obtained:
MicroDL FULL REPORT
Patient Name:________________________________
Test: 1 Date: 12/11/97 Time: 0802
ID: 6 Sex: Male Age: 19
Height: 190 cm Ethnic Correction: 0%
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Parameter Result %Best Best %Pred Pred Min Max Units
FEV1 3.71 78 4.76 74 4.95 4.11 5.79 L
FVC 4.61 82 5.62 77 5.95 4.95 6.95 L
PEF 9.67 92 10.65 90 10.74 8.75 12.73 L/S
FEV1%FVC 80 97 82 97 82 70 94 %
F50 4.15 68 6.07 3.90 8.24 L/S
F25 1.36 45 2.96 1.68 4.24 L/S
MEF 5.45 102 5.31 3.60 7.20 L/S
FET 4.66 S
Flow/Volume Volume/Time
RESULT
PREDICTED
12
10
8
6
4
2
S
/
L
1
2 3 4
5 6 7 8
FEV1
8L
6
4
2
1
2 3 54 6 7 8
Normal Values: ECCS (adult); Zapletal,Solymar,Cogswell (child)
Results at BTPS
Technician:_______________ Physician:_______________
RESULT
PREDICTED
The first line gives the MicroDL version number and type of report.
Subsequent lines give the test number, date and time of test, and
patient details. This is followed by the test results presented with
the percentage of personal best value, the personal best value, the
percentage of predicted value, the predicted value, the predicted
minimum and maximum, and the unit of measurement.
The expiratory Flow/Volume and Volume/Time curves are also
shown overlaid with the predicted curves and FEV1 marker on the
23
Flow/Volume curve. Please note that personal best values cannot be
entered in multiple patient mode.
To obtain subsequent copies of the report press ‘enter’. When all
the required printouts have been obtained press ‘off’ and the unit
will turn off.
Option 3 – full spirometry report of all records
After turning the MicroDL on with the up key depressed, use the up
key twice to obtain printing option 3. The display will show:
This option is used to print full spirometry reports, including
Flow/Volume and Volume/Time curves, on all the stored results.
The ‘65’ indicates that sixty-five sheets of paper will be used, as
there are currently sixty-five tests stored. Press ‘enter’ if this option
is required. The display will show:
The printouts obtained will be identical to the single report produced
with option 2.
At any time during printing pressing ‘off’ will terminate the printing.
Should the printer fail to operate correctly then turn off both the
printer and the MicroDL unit, check all connections, and try again.
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Option 4 – summary report of all records since last printout
After turning the MicroDL on with the up key depressed, use the up
key three times to obtain printing option 4.
The display will show the following:
This option is used to print a summary report of all the results that
have been recorded since the last summary report was printed.
Press ‘enter’ if this option is required. The display will show:
The printouts obtained will be identical to the summary report
produced with option 1, but with fewer entries if a summary report
has been previously obtained.
Option 5 – full spirometry report of all records since last
printout.
After turning the MicroDL on with the up key depressed, use the up
key four times to obtain printing option 4. The display will show:
25
This option is used to print full spirometry reports of all the results
that have been recorded since the last time that printing option 3
was used.
Press ‘enter’ if this option is required. The display will show:
The printouts obtained will be identical to the single report produced
with option 3.
PC Based Spirometry
The MicroDL can be connected to a PC and interfaced to
CareFusion’s spirometry data management software SPCS.
SPCS enables you to record, manage, and display spirometry
information. Its main features are:
A fully featured spirometry database.
An interface, which enables the unit to be controlled from the PC and
provides live display of Flow/Volume, and Volume/Time graphs
together with a child incentive display.
Reporting facility including a full set of parameters, predicted values,
graphs and interpretations.
Trend analysis of spirometry data.
26
Configuring the MicroDL with SPCS
The MicroDL can be set up using SPCS. First, ensure that the
MicroDL is connected to the PC using the cable supplied. Connect
the nine way ‘D’ connector to the serial port of the PC and the 3 pole
jack plug to the socket in the right hand side of the MicroDL.
To communicate with the PC the MicroDL must be turned on in PC
mode. Depress the ‘enter’ key, turn the unit on, and release the
‘enter’ key when the display shows:
Start SPCS on the PC. Ensure that SPCS is set up to use the COM
port on the computer that the MicroDL is connected to (refer to
online SPCS help). A patient record should then be set up
containing the details to be downloaded to the MicroDL (or an
existing patient selected). These details can then be used to
initialise the unit. Please refer to the online help included with SPCS
for the exact details for performing these operations.
NOTE: Keep the PC out of reach of the patient when connected to
the MicroDL. The MicroDL should only be connected to a computer
that is manufactured in accordance with EN60950 1992/1993 ‘Safety
of Information Technology Equipment including Electrical Business
Equipment’.
Uploading Results
To upload the results stored in the MicroDL, connect the unit to the
PC as described above and start SPCS. When the initial screen is
displayed, click on the ‘upload‘button. The data contained in the
27
unit will then be uploaded into the SPCS database (refer to online
help for further information).
Please note that the patient details for any data uploaded into SPCS
from a unit that has been set-up by hand, should be entered into the
SPCS database. This will allow the uploaded spirometry records to
be displayed and trended.
The patient IDs used in the unit should match those in the SPCS
database.
NOTE: Keep the PC out of reach of the patient when connected to
the MicroDL.
To connect the unit to the PC; connect the cable to one of the PC’s
serial communications ports and turn the unit on with the ‘enter’ key
held down. The unit display should show ‘PC’ flashing. Now run
SPCS on your PC (for more information on SPCS, refer to online
help).
Battery Management
There are two sources of internal battery power in the MicroDL.
The recorded data is stored in a battery-backed memory, supplied
by a Lithium power source with an expected life of at least 10 years.
This battery also supplies the timekeeping clock.
The microcomputer circuitry is supplied by a 9 volt, alkaline PP3
battery. The battery life is approximately 24 hours of continuous
use.
The battery voltage is monitored continuously and the following
warning message is displayed when the battery starts to become
exhausted:
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