CareFusion Micro Diary Operating Manual

Micro Diary

Operating Manual

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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

CAUTI ON: ................................................................... 7

PA CKA GE CO NT ENTS ................................................... 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

1 PC CONNECTION ...................................................... 19

2 MESSAGE LOG ......................................................... 19

3 TRAINING BLOW ....................................................... 19

4 SE R I A L NU M B E R ....................................................... 19

5 UNIT ID ................................................................. 19

6 RE C O R D CO U N T ....................................................... 19

7 CA L I B R A T I O N CHECK ................................................. 20

8 TELEPHONE LO G ....................................................... 20

MAINTENANCE .......................................................... 20

BATTE RY MANAGEMENT ................................................. 20

BATTERY REPLACEMENT ................................................. 21

CALIBRATION CHECK .................................................... 21

CLEANING THE TRANSDUCER .......................................... 22

SERVICING ................................................................. 23

TROUBLE SHOOTING INFORM AT I ON......................... 23

ELECTROMAGNETIC COMPATIBILITY (EMC) .............. 24

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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

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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 E V6,
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. Various identifiers such as trial centre, 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 option al alar m.
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,

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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 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.

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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, the Micro Diary Spirometer
measures the following lung function parameters: FEV1,
FVC, FEV6, an d 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.

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Environment

Please observe the following precautions:

• Avoid exposing the Micro Diary to direct sunlight.

• 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

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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 patient there is a risk of cross-

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.

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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. Ca reFu sion Digital Volume Transducer.

3. Lithium coin cell, CR2450

4. USB cabl e

Figure 1: The Micro Diary

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