Care Fusion Micro Diary User manual

Micro Diary
Operating Manual

1
CONTENTS
INTRODUCTION ........................................................... 3
INDICATIONS FOR USE................................................. 5
TARGET POPULATION.................................................. 5
ENVIRONMENT OF USE ............................................... 5
ENVIROMENT CONDITION OF USE .............................. 6
CONTRAINDICATION, WARNINGS AND CAUTIONS...... 6
CONTRAINDICATIONS ..................................................... 6
CAUTION: ................................................................... 7
PACKAGE CONTENTS ................................................... 8
CONFIGURATION......................................................... 9
OPERATION ............................................................... 11
SP I R O M E T R Y RE C O R D I N G ............................................... 11
SYMPTOM SC O R E E N T R Y ................................................ 14
MENU OPTIONS .......................................................... 18
1PC CONNECTION ...................................................... 19
2MESSAGE LOG ......................................................... 19
3TRAINING BLOW....................................................... 19
4SE RI A L NU M B E R ....................................................... 19
5UNIT ID................................................................. 19
6RE C O R D COU N T ....................................................... 19
7CA L I B R A T I O N CHECK ................................................. 20
8TELEPHONE LOG ....................................................... 20
MAINTENANCE .......................................................... 20
BATTERY MANAGEMENT ................................................. 20
BATTERY REPLACEMENT................................................. 21
CALIBRATION CHECK.................................................... 21
CLEANING THE TRANSDUCER .......................................... 22
SERVICING ................................................................. 23
TROUBLE SHOOTING INFORMAT ION......................... 23
ELECTROMAGNETIC COMPATIBILITY (EMC).............. 24

2
CONSUMABLES & SUPPORT I N G P R O D U C T S .............. 24
SPECIFICATION OF THE MICRO DIARY ....................... 25
SYMBOLS ................................................................... 26
CUSTOMER CONTACT INFORMATION ....................... 27
UK CUSTOMERS ONLY................................................... 27
INTERNATIONAL CUSTOMERS ONLY ................................... 27

3
Introduction
The Micro Diary spirometer is a compact, battery
operated, and fully portable data recording spirometer
designed specifically to collect FEV1, PEF, FVC or F EV6,
and symptom scores in epidemiological studies and drug
trials.
The Micro Diary connects to a PC for configuration and
uploading of stored data using the Micro Diary System
Windows™ based software. This software allows the unit
to be easily customised for a particular trial and includes
many built in safeguards to ensure the integrity of the
accumulated data.
The unit can be configured to take spirometry readings
and symptom scores, entered either numerically, on an
analogue scale, or from a scroll down list of responses.
The results are stored together with the time and date of
testing. Variousidentifierssuchastrialcentre,unit
number, and description are also stored.
Different sequences of questions and spirometry tests may
be configured for 4 individual time zones. Each sequence
is activated by the subject turning the unit on, within the
relevant time zone, or by answering an optional alarm.
After completing a sequence the unit turns off
automatically. Having completed a time zone sequence, a
supplementary sequence will be activated if the unit is
turned on again within the time zone or between zones.
Note that once a time zone sequence has been completed,

4
the sequence cannot be repeated until the following day.
During a sequence the last spirometry test or
questionnaire response can be erased by pressing ‘del’.
The recorded tests can be uploaded to a computer for
future analysis or printing, via a USB interface.
The spirometer uses the C a r e F u s i o n DigitalVolume
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.

5
Indications for Use
The Micro Diary Spirometer is used in pulmonary function
testing to measure the volume of gas moving in or out of
a patient's lungs. Specifically,theMicroDiarySpirometer
measures the following lung function parameters: FEV1,
FVC, FEV6, and PEF. The device also records the test data
for later review and has the ability to transfer these
records to a compatible computer.
Target Population
The device can be used on patients who require lung
function measurements. It can be utilized for patients
from 4 years and older, providing that they are able to
follow the medical practitioner’s instructions.
Environment of Use
The environment of use is the hospital or a doctor’s or
medical practitioner’s office or clinic or the patient’s home.

6
Environment
Please observe the following precautions:
•AvoidexposingtheMicroDiarytodirectsunlight.
•Avoid operating the spirometer in dusty conditions or
near to heating appliances or radiators
•Do not keep the spirometer in a damp or expose it to
extreme temperatures
•Operate the equipment under normal enviromental
temperatures which are defined in this manual (see
section “Specification of the Micro Diary”)
•The transducer should not be hold towards a strong
light source during operation of the spirometer.
Contraindications, Warnings and
Cautions.
Contraindications
•Acute disorders affecting test performance (e.g
Vomiting , nausea, vertigo)
•Recent eye surgery (increases in intraocular
pressure during spirometry)
•Oral or facial pain exacerbated by a mouthpiece

7
Caution:
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in
the presence of explosive or flammable gases,
flammable anaesthetic mixtures or in oxygen rich
environments.
CAUTION: Mouthpieces are single patient use. If used
on more than one patientthereisariskofcross-
infection. Repeat use may degrade materials and lead
to an incorrect measurement.
PLEASE NOTE: The product you have
purchased should not be disposed of as
unsorted waste. Please utilise your local
WEEE collection facilities for the disposal of this
product.

8
Package Contents
The Micro Diary is packaged in a convenient carrying case
and comes complete with the following items (Fig.1):
1. Micro Diary microcomputer unit.
2. CareFusion DigitalVolumeTransducer.
3. Lithium coin cell, CR2450
4. USB ca bl e
Figure 1: The Micro Diary
Delete
Enter
On
Scroll down
Scroll up

9
Configuration
Before using the Micro Diary the required sequence of
questions and spirometry tests must be defined using the
PC software (Please see Help files on software for
guidance). Micro Diary PC Software may be downloaded
using the link:
http://www.micromedical.co.uk/update/download.asp
(The PC Software is intended for use by Clinicians
and Trial co-ordinators only).
Once defined, the sequence can be loaded into the Micro
Diary. This can be done with a direct connection to a USB
port of the PC: plug the unit into a USB port on the PC,
using the cable provided, and turn the unit on with the
‘enter’ key depressed to display the operations menu.
Once the operations menu is displayed, release the ‘enter’
key. Scroll to option 1, PC Connection, using the up and
down keys and then press ‘enter’ (the other options are
described in section Menu Options). From the PC
software, download the program to the unit and switch off
by pressing ‘del’.
The Micro Diary is now ready to perform the defined
sequence of questions when the unit is turned on. The
subject is instructed to complete the sequence of
questions and spirometry tests. Once complete, the unit
will turn off automatically.
If the subject turns the unit on but leaves the unit before
completing the sequence, the unit will automatically turn

10
off after several minutes. Data collected on a partially
completed sequence will not be stored and the subject
must turn the unit on again and complete the whole
sequence before the results are stored.
If an alarm is set then the unit will turn on automatically
at the required time, sound an audible alarm, and display:
The subject should then press ‘enter’ to initiate the
sequence. If no response is given the unit will turn itself
off after a few minutes (configurable) and repeat the
alarm every 11 minutes (configurable) until the end of the
time zone.
When turned on, the subject will be requested to perform
a spirometry manoeuvre or to enter the answer to
questions in the order specified in the program.
In order to familiarise the subject with the spirometry
manoeuvre a test may be performed without the results
being stored. To do this, turn the unit on in the ‘options’
menu, as described above. Then scroll to option 3, training
Blow and press ‘enter’. A spirometry manoeuvre will be
requested as outlined in the next section. Pressing ‘del’
will return the unit to the options menu.

11
Operation
Spirometry Recording
When taking a spirometry measurement the following will
be di s pl a ye d:
The subject should then perform a spirometry manoeuvre
using a clean mouthpiece connected to the transducer.
After completion the display will show the results together
with a spirometry manoeuvre quality check:

12
The results and quality checks displayed to the user may
be configured with the PC software. The software may
also be configured to automatically reject any manoeuvre
that fails any of the quality checks. The unit will ‘beep’
once at the end of the manoeuvre or three times if an
alarm has been set and the result is below the acceptable
level. The arrow at the bottom right of the screen
indicates that the ‘down’ arrow key may be used to obtain
more results. Using the ‘down’ arrow key will di s pl ay t he
flow/volume curve, if configured by the PC software:

13
The Quality checks can result either in discarding the blow
or not. See the Quality Assurance Options page from the
help files.
When an acceptable test has been performed, pressing
‘enter’ will move on to the next test or symptom score
entry and save the spirometry results. When performing a
series of tests it is possible to configure the unit to record
only the best blow.
The unit may also be configured to alarm when the
spirometry manoeuvre is below a set value or below a set
percentage of the recorded best effort. When a
manoeuvre is below the required level an alarm will sound
continuously and the display will flash the reading, which
has triggered the alarm.
If for any reason the subject is not satisfied with their
effort, pressing ‘del’ will cause the test to be repeated and
the results will not be stored until ‘enter’ is pressed.
Repeatedly pressing ‘del’ will erase, in turn, all the tests
performed and may be used to erase a whole sequence if,
for example, the subject decides that they are not able to
complete a set of tests at that time.
Please note that the results to be displayed, and stored,
are individually selected by the program. It is therefore
possible, for example, to store FEV1 and FVC but display
no results if a blind study is to be undertaken. In this
case the Micro Diary will move on to the next question or
spirometry test immediately after the test is performed
unless the effort is below the minimum requirement in

14
which case the alarm will sound and the display will flash
the reading that triggered the alarm.
Symptom Score entry
Numerical data and responses to questions may be
entered in five different ways.
Question with Numeric Answer:
The question is displayed atthetopofthescreenandthe
defaultresponseisshownflashingbelow. Notethatwhen
an‘upor‘down’keyisfirstused,thedefaultnumber
stops flashing. Subsequent use increments the number up
or down.
Inordertoavoidthepossibilityofthesub je ct si mpl y
pressing ‘enter’ repeatedly to accept all default values in a
series of questions, the ‘enter’ key is only recognised after
an ‘up’ or ‘down’ key is used at least once.
Question with Decimal Numeric Answer:

15
The display shows the question number with the default
response(setbythePCsoftware)toonedecimalplace.
The subject adjusts the response, as described above, and
then presses ‘enter’. Note that it is not possible to enter
the default value whist the display is flashing. Pressing
the‘up’or‘down’oncewillstoptheflashingand
subsequent use will increment or decrement the value.
This feature ensures that the subject actively reviews the
value and does not repeatedly press ‘enter’ for a sequence
of questions in order to save time.
Question with Short Written Answer:
Whenthistypeofquestionisdisplayedtheuserusesthe
‘up’and‘down’arrowkeystoselectthecorrectresponse
and then presses ‘enter’. If there are more answers than
canbedisplayedonthescreen,anarrow wi ll be di s pl ay ed
toindicatethatfurtheranswersareavailable.Asbefore,

16
the default response flashes until the ‘up’ or ‘down’ arrow
keys are first used.
Question with Long Written Answer:

17
Whentheanswersaretoolongtofitononeline,paged
responsesmaybeused.Usingthe‘up’and‘down’keys
will scroll between the programmed responses. Pressing
the ‘enter’ key will select the required response.
Question with Analogue Scale Response:
Question requiring an answer on an analogue displ ay c an
alsobedisplayed.Theuserusesthe‘up’and‘down’
arrowstomovethesolidbartotherightandleft.When
the required level is displayed press ‘enter’ to store the
result.

18
Menu Options
Toobtaintheoptionsmenuholddownthe‘enter’key,
turn the unit on, and when the sounder is heard release
the ‘enter’ key.
Usetheupanddownarrowkeystoselecttherequired
option and then press enter.
Select option 9, Exit, when you have finished using the
options.

19
1 PC Connection
WhenthisoptionisusedconnecttheDiaryunittoaPC
running the software supplied to a USB port using the
cable supplied. The Diary is then controlled by the PC in
order to upload saved data or to reprogram the unit.
2 Message Log
The feature is not used in the Diary system.
3 Training Blow
Usethisoptiontoallowtheusertofamiliarisethemselves
withperformingaspirometrytest.Noneofthetests
performed in this mode of operation will be stored.
4 Serial Number
Use this option to identify the serial number of the unit.
5 Unit ID
Use this option to display the programmed Unit ID and the
FullID.Theseidentifiers,loadedintotheDiaryatthe
time of programming.
6 Record Count
Arecordcountandthepercentageofmemoryusedis
avail ablewiththisoption.