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					     spirotel



     User’s manual




     MEDICAL INTERNATIONAL RESEARCH




Users Manual Rev. 4



Prepared by Arne Langenkamp
Date 26 / 06 / 2001

Approved by Paolo Sacco Boschetti
Date 26 / 06 / 2001




                                      1
Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product.

The original packaging contains:

    Article Code                          Description
910520 / 910521 spirometer spirotel “classic”/”pro”
        970432          3 V DC lithium battery model CR 123A
        980100          spirotel User’s Manual
        980102          spirotel Configuration Manual

Before using your new spirometer…
 Read the User’s Manual carefully and read all of the labels supplied
   with the unit.
 Install the operating battery (if not already installed), taking care
   to connect correctly as shown inside the battery housing.
 Select the required display language.

Please keep the original packaging!
 In the event that your unit has a problem use the original
   packaging to return the unit to your distributor or to the
   manufacturer.
    The manufacturer reserves the right to modify the information contained within this
    manual due to ongoing product development and product improvements.
    Note that due to printing limitations the screenshots shown in this manual may differ
    from the display of the machine and/or from the keyboard graphics
    Copying this manual in whole or in part is forbidden.




2
                           INDEX                     Page

1. INTRODUCTION                                        4
   1.1 Intended use                                    4
   1.2 Important safety warnings                       7
   1.3 Unforeseen errors                              11
   1.4 Labels and symbols                             12
   1.5 Product description                            13
   1.6 Method of test interpretation                  15
   1.7 Technical specifications                       16
   1.8 Monitoring pulmonary disorders                 19
   1.9 Personal best values                           20
2. OPERATION OF SPIROTEL                              22
   2.1 Keyboard                                       22
   2.2 Battery level                                  23
   2.3 To make a test                                 24
3. TRANSMITTING DATA                                  34
   3.1 Data transmission via telephone                34
   3.2 Data transmission via (GSM) mobile phone       36
   3.3 Data transmission via modem                    38
4. MAINTENANCE                                        41
   4.1 Cleaning and general control of the turbine    41
   4.2 Changing the battery                           43
5. POSSIBLE PROBLEMS                                  44
   5.1 Causes and solutions                           44
6. MEASURED PARAMETRES                                45
Declaration of EC Conformity                          46
Limited Warranty Conditions                           47



                                                       3
1. INTRODUCTION

1.1     Intended use

User category
The spirometer calculates a series of parameters relating to
human respiratory function.
The product is intended for use by the patient at home
under the supervision of a doctor. The doctor “prescribes”
the use of the instrument and is then responsible for the
analysis and control of the results and the data collected
during the control period.

Qualification and experience required
The use of the instrument is very simple indeed, but the
users must be instructed in the correct use by a doctor.

Operating environment
It is foreseen that the normal operation of the instrument will
be at home, at work, at school or during sports. Day by day,
the spirometer records information and functional respiratory
parameters for a period of weeks or months, which helps
the patient to follow the variability of his own for a better
assessment of his own health.
The instrument is not intended for use in an operating
theatre of in the presence of inflammable liquids or
detergents, nor in the presence of inflammable anaesthetic
gases of oxygen or nitrogen.


4
The instrument is not designed to be used in direct air
currents (e.g. wind), sources of heat or cold, direct sun rays
or other sources of light or energy, dust, sand or any other
chemical substances.

Who must/can make the installation
The spirometer requires installation by qualified personnel.
Normally the responsible doctor configures the spirometer
before giving it to the patient for the period of use at home.

Patient effect on the use of the instrument
A spirometry test should only be carried out when the
patient is at rest and is in good health, and thus in a suitable
condition for the test. A spirometry test requires the
collaboration of the patient, the patient must make a
complete forced expiration in order to have a meaningful
test result.

Limitations of use – Contraindications
An analysis of the results of a spirometry test is not by itself
sufficient to make a correct diagnosis of the patient’s clinical
condition. A detailed clinical history of the patient is also
required together with any other tests or analyses
suggested by a doctor.
Test comments, test interpretation and suggested treatment
must be given by a doctor.
Any symptoms that the patient has at the time of the test
must be carefully considered before a spirometry test is
made. The doctor who prescribes the use of the spirometer


                                                              5
must first assess both the mental and the physical capacity
of the patient to be sure of his/her ability to make the test.
Also, the responsible doctor who evaluates the saved data
of the spirometer must assess the grade of collaboration of
every made test.
The acceptability of a test is the responsibility of the doctor.
Special attention should be given to testing elderly patients,
children plus handicapped people.
The spirometer should never be used when it is possible or
probable that the validity of the results may be compromised
due to any such external factors.




6
1.2        Important safety warnings


ATTENTION:                                   !
 The safety and the correct performance of the unit can only be assured if the user of the
 instrument respects all of the current safety rules and regulations.
 The manufacturer accepts no responsibility for problems or damage caused by the failure
 of the user to follow these instructions correctly.
 The instrument must be used as described in the User’s Manual with particular attention
 to § Intended Use and only original spares and accessories as specified by the
 manufacturer may be used. The use of a non-original turbine sensor of other parts could
 cause measurement errors and/or compromise the correct functioning of the instrument,
 and is therefore not permitted.


 ATTENTION:                                  !
 With the entry in force of the European Directive 93/42 on the use and operation of
 medical devices, in the event of any accident caused by the use of the instrument the user
 is obliged to inform the manufacturer or the manufacturer’s representative as quickly as
 possible.




                                                                                              7
  Danger of cross-contamination
The instrument uses a turbine sensor. A mouthpiece is
required to connect a patient to the spirometer.

In order to avoid exposing the patient to the critical
danger of cross contamination, the turbine sensor must
always be sterilised before each spirometry test, and a
new monouse mouthpiece must be used for each new
patient.

The turbine
An incorrect or insufficient sterilisation or cleaning of the
turbine could be a cause of infection for the patient.
In the case that the instrument is operated for personal use
then it is not necessary to sterilise the turbine between tests,
but even in this case a regular sterilising or at least cleaning
is strongly recommended. See the relevant paragraph within
this manual for details of the correct sterilising operation.
Do not expose the turbine sensor to a direct jet of water or
air nor allow it to come into contact with liquid at high
temperature.
Do not allow dust or foreign bodies to enter the turbine
sensor, to avoid incorrect functioning and possible damage.
The presence of any impurities such as hairs, sputum,
threads etc within the body of the turbine sensor may “brake”
the propellor and thus seriously compromise the accuracy of
the measurements.




8
The mouthpiece
Any mono-use mouthpieces included with the instrument are
supplied only as a guide to the correct type and dimensions
of the mouthpiece required for this instrument, they are
clean but not sterile. To purchase appropriate mouthpieces
(generally either paper or plastic, in any case mono-
use/disposable) we suggest that you contact your local
distributor who supplied the spirometer.
The use of a mouthpiece made from an inappropriate
material could modify the bio-compatibility and could be the
cause of an incorrect functioning of the instrument and thus
of incorrect test results.
The user is responsible to obtain the correct type of
mouthpieces for the instrument. Those required are a
standard type with an outside diameter of 30mm, they are
commonly used and in general easily procured.

The maintenance operations detailed in this manual must be
carried out precisely. If these instructions are not followed
this can cause measurement errors and/or an incorrect test
interpretation.

Any modifications, adjustments, repairs or reconfiguration
must be made by the manufacturer or by personnel
authorised by the manufacturer. Never attempt to make a
repair oneself.

The set-up of configurable parameters should only be made


                                                           9
by qualified personnel. However, an incorrect set up of the
parameters does not put the patient at risk.

High-frequency emissions may interfere with the correct
operation of the instrument. For this reason, certain
minimum clearances (a few metres) should be observed
when high-frequency appliances such as a TV, radio,
portable phone etc and other electronic units are operated at
the same time in the same room.
If the instrument is connected to any other instrument then,
in order to maintain the essential safety characteristics laid
down by EN 60601-1-1 only equipment which complies to
the current safety regulations may be used.

For the recycling of the spirometer, accessories, plastic
consumable materials (mouthpieces) plus the battery, use
only the appropriate containers or (better) return all such
parts to the seller of the instrument or to a recycling centre.
All appropriate local regulations must be followed.

Use only a battery of the type indicated in the § Technical
specifications. Remove the battery from the device if the
machine is not used for a long period (several months).




10
1.3         Unforeseen errors

In the case of a problem, one of a series of messages to
indicate the nature of the problem will appear on the screen
together with warning “beep”.

If appropriate and timely action is not taken in the event of
such messages appearing during the life of the instrument
then it is possible that the instrument will “lose” the data in its
working memory (SRAM).

Errors in measurement or in interpretation can also be
caused by:
 use by non-qualified or non-trained personnel, lacking
   ability or experience
 user error
 use of the instrument outside the guidelines described in
   this User's Manual
 use of the instrument even when some operational
   anomalies are encountered
 non-authorised servicing of the instrument

NOTE:
 MIR has a policy of constant product improvement, the information contained in this
   document is therefore subject to change without prior notice. MIR shall not be liable for
   any errors contained herein or for any damages in connection with the use of this
   material.



                                                                                        11
 Due to printing limitations the images shown in the manual may differ from the images
  shown on the display of the spirotel (LCD).
 No part of this document may be copied in whole nor in part nor translated into another
  language without the prior written consent of MIR srl.

1.4        Labels and symbols



                          spirotel identification label

This label contains:
 Name and address of the manufacturer
 Product’s name
 Mark of conformity with the directive 93/42 CEE
 Serial number of the product




           0476
EC mark for medical devices.
This product is certified to conform to the requirements of
the 93/42/CEE medical devices directive.




12
Electrical safety symbol. In accordance with the EN 60601-1
the product and its component parts are of type BF and
therefore protected against the dangers of direct and indirect
contact with electricity.


            Warning symbol for the RS232 serial port. For
connection to other devices such as PC or printer. Use only
the serial cable supplied by the manufacturer and observe
the safety regulations of EN 60601-1-1.

1.5     Product description

spirotel is a simple to operate precise pocket spirometer
(weight only 100g) able to measure the most important
functional respiratory parameters with a quality control check
on the test carried out and a memory capacity sufficient for
several hundred tests.

To make a meaningful interpretation of the measured
spirometry parameters, the measured parameters must be
compared either to the so-called "normal" or "predicted"
values which are calculated from the anthropometric data of
the subject or (as an alternative) to the "personal best"
values taken from testing made by the individual subject.
Given that the predicted values are an average taken from a
healthy population they can of course vary significantly from
the personal best values of an individual subject.


                                                           13
spirotel is able to transfer the spirometric data stored in its
internal memory over the telephone line (using a simple
acoustic coupling) to the PC of the doctor. The doctor is thus
able to have, at regular intervals and/or at any time (as
required), objective "remote" data on the current condition of
his patient, this data when collected over a period of time is
invaluable for the doctor to understand the efficiency of the
treatment or the therapy of the patient.

spirotel can be connected directly to a PC (through a
custom optoisolated serial cable and microinterface) under
Windows, and from the PC the device can be configured for
the individual subject, the spirometric data can be
downloaded from the device to the PC and the spirometric
data can be viewed (Flow/Volume and Volume/time curves
plus spirometric parameters) corresponding to every test
made by the subject and stored within the device.

spirotel gives a simple traffic light summary of the test
interpretation. This test interpretation is based on the ATS
(American Thoracic Society) standards of 5 levels of
obstruction, 5 levels of restriction and one of normal
spirometry, the instrument thus gives a valid support to the
doctor to make a functional diagnosis.

The sensor for flow and volume measurement is a turbine
sensor based on the infrared interruption principle. This
measurement      principle guarantees    accuracy    and


14
reproducibility of the measurement without the requirement
of constant calibration. Sterilisation is simple as the only
requirement is to withdraw the turbine tube and to immerse it
in a cold sterilising solution.

The power supply is a 3V battery and the battery life is in the
region of two years.

1.6     Method of test interpretation

Following every FVC test (forced expiration) the instrument
makes a quality control check to verify the validity of the test
made and, if possible, to compare the principal measured
parameters FEV1, FEV1% and FVC with the respective
normal (predicted) or personal best values. It also calculates
a series of indices as per the following criteria:

      index % = measured value / normal value x 100

The connection between the colours and the functional
interpretation are as follows:

FEV1 or PEF > 80%            Green: No problem
FEV1 or PEF > 50% < 80% Yellow: Caution
FEV1 of PEF < 50%            Red: Alert, contact your doctor
This default values can be modified by the doctor during the
configuration process.



                                                             15
1.7    Technical specifications

The following is a complete description of the technical
characteristics of the instrument and of the flow and volume
sensor.

Parameters measured:
FET, FEV1, FEV1%, FVC, PEF, FEF 2575
Memory:
Hundreds of tests, including parameters, Flow/Volume and
Volume/time curves. The exact number is not known as it
depends on the configuration made by the doctor
Display:
LCD, 2 lines, 16 characters
Keyboard:
5 keys
Interface:
RS 232 bi-directional
Power supply:
Lithium battery 3 V, type CR123A
Dimensions:
70x80x30 mm
Weight:
100 g (including operating battery)

Flow/Volume sensor:
Bi-directional turbine
Measuring method:


16
Infrared interruption
Max volume:
10 L
Flow range:
16 L/s
Volume accuracy:
3% or 50 mL
Flow accuracy:
5 % or 200 mL/s
Dynamic resistance at 12 L/s:
<1 cmH2O/L/s
Type of electrical protection:
Class II device
Safety level for shock hazard:
Apparatus type BF
Protection against water penetration :
Standard device
Safety levels during use in presence of inflammable
anaesthetic gases or oxygen or nitrogen:
Apparatus not suitable
Conditions of use:
Apparatus for continuous use
Conditions of storage :
Temperature: MIN 0 °C, MAX + 40 °C
Humidity :MIN 10% RH; MAX 95%RH
Operating Conditions :
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH


                                                      17
Applied norms:
Electrical Safety Standard EN 60601-1
Electro Magnetic Compatibility EN 60601-1-2
Expected working life:
A life expectancy of 10 years is declared

 This device is a Class IIa medical device according to the European Directive 93/42/CEE.




18
1.8     Monitoring pulmonary disorders

Using spirotel on a regular basis (in conjunction with your
doctor) makes it possible to identify and to follow an efficient
course of therapy and you will be able to improve the
performance of your lung function.

spirotel measures the expired flow and volume of the air
expired from the lungs and is designed to make it easier to
monitor pulmonary disorders. In the case of asthma in
particular, spirotel helps the patient to predict asthma
attacks or at least better to understand his or her condition.
The peak flow is the maximum peak expiratory flow, the
highest air velocity measured when the air is expired with
maximum force from the lungs. spirotel measures and
memorised this parameter (measured in litres per minute)
together with several other key parameters which measure
the current condition of the lungs. Also, the machine
functions like an electronic diary and has a memory capacity
to memorise a series of information. For example levels of
symptoms like cough or wheezing can be recorded and it
can be specified if the test has been carried out after taking
a drug such as a broncodilatator. It is also possible to
specify if the test has been carried out at work.
All this information when recorded together with the lung
function is invaluable to the doctor, he is thus able to collect
and to analyse all of this data with a computer and thus will
be able to give a more correct diagnosis and/or will be able
to check objectively if the therapy being used is appropriate


                                                             19
or effective. When necessary via a simple telephone call all
of the collected data can be transferred to the doctor's PC.

1.9     Personal best values

To make a correct evaluation it is necessary to have the
base personal reference values. These values are recorded
when the spirotel is initially programmed (or “configured”)
by your doctor. All tests which are then carried out by you
will use these values as a reference.
The personal reference values can be quite different from
the so called normal values obtained from the predicted
value sets which are based simply on the age, height and
sex of the subject. These values are based on data taken
from a healthy population.
The best method to check your own condition day by day is
the comparison of your own measured values with the
personal reference values indicated by your doctor. To give
you a complete picture of your situation the spirotel shows a
small graph indicating the “average” of the daily measured
values during the last 10 days.
The second factor to check is the daily VARIABILITY
(morning/evening), that is to check how the two key
parameters the peak flow (PEF) plus the volume expired in
the first second of the test (FEV1) vary over the course of a
day. Normally (in the case of asthma) the best values are
measured in the morning.
The variability is a very important measurement: for example
if the daily VARIABILITY increases this is a possible


20
indication of an oncoming asthma attack. After each
measurement the spirotel automatically calculates the
VARIABILITY and indicates on the display if the variability
exceeds the limits established by the doctor.


ATTENTION:                               !
 Before using spirotel please check if your doctor has “personalised” the instrument
 by programming all data as mentioned in the so called “configuration”.




                                                                                  21
2.     OPERATION OF THE SPIROTEL

2.1.     Keyboard

All spirotels have a keyboard consisting of 5 keys:




             “Classic”                 “Pro”

 "" key ( ) has several functions:
 The

     SWITCH ON to switch on the spirotel press and release
     SWITCH OFF to switch off the spirotel press the key for
                at least 2 seconds
     ENTER      to confirm and proceed to the next phase

 The "0" key (is generally used to answer the questions
  shown on the display.

 The “1” key is generally used to answer the questions
  shown on the display.




22

 The "2" key (is generally used to answer the questions
 shown on the display.

 The “" key is used for initiating the data transmission

 via telephone, mobile phone or modem,. For detailed
 information please refer to the § “TRANSMITTING DATA”.

2.2    Battery level

The symbol     indicates that the battery is charged. The
maximum charge of the batteries is indicated when four of
these symbols appear. As the battery charge reduces then
the symbol .is shown.

In case the battery is completely discharged the following
message is shown on the display:

                       LOW BATTERY


2.3    To make a test

Switch on the spirotel by pressing the "" key
The following message is shown:

                   Ver x.y.
                   Memory free. 95%



                                                       23
The software version is indicated on the first line and the
percentage of memory remaining on the second line.

If no tests or information have been stored the following
message is shown:

                   Ver x.y.
                   Memory empty

After circa one second the current date and time are shown
on the display:

                   DATE 20/10/97
                   TIME 16 : 48 : 55

If during the configuration of the machine your doctor has
programmed some symptom questions then at this stage
one or more questions will be shown on the display, which
you must answer. The questions are decided by your doctor.
Here follows the complete list:

                   BREATH DIFFICULT
                     No Med Max

Press one of the three keys 0/1/2         which correspond
respectively to the following answers: No Med Max. Indicate
the current severity of this symptom according to the
following guide:


24
No      to indicate symptom absent;
Med     to indicate symptom present (medium);
Max     to indicate symptom present (severe);
 “"     to avoid or bypass this question

In the same way it is possible to answer the other symptom
questions:

                   BREATH DIFFICULT
                     No Med Max

                   CHEST TIGHTNESS
                     No Med Max

                   COUGH
                    No Med        Max

                   SPUTUM PROD.
                     No Med Max

                   TROUBLED SLEEP
                     No Med Max


                   WHEEZING
                    No Med        Max




                                                       25
Once inserted, the symptom questions can only be changed
by connecting spirotel to a computer with the software
Océan WinSpiro or by deleting all test data. In any case,
these two options should only be made by the doctor.

                               WORKING DAY ?
                               Yes       No

 Yes            to indicate that the current test is made during a
                 working day (also if you are still at home).

 No              to indicate it is not a working day

                               TAKEN DRUG?
                               Yes       No

NOTE:
If more tests are made on the same day the question(s) is/are not repeated.

The (optional) inspiratory phase can be carried out before
connecting to the mouthpiece.

To perform a good spirometry test the following instructions
must be strictly followed:
 the nose clip to the nose in order to ensure that no air
   Fit
   can escape from the nostrils.
 Insert the mouthpiece well into the mouth, so that at
   least 2 cm of the mouthpiece is inside the mouth and



26
   close the sides of the mouth tightly around the
   mouthpiece in order that air cannot escape.


ATTENTION:                                   !
 It is absolutely necessary to keep the mouthpiece between the teeth in order to avoid that
 the opening of the mouthpiece is obstructed by the lips.
 If the mouthpiece is obstructed this can have a negative result on the test results.

After a slow and deep inspiration the forced expiration must
be made by making a complete forced expiration as fast as
possible. To made a correct spirometric test it is absolutely
necessary that all air is expired from the lungs.

The measurement finishes automatically several seconds
after the last volume variation (at flow zero), or by pressing
the “ “ key.

Some messages are then shown to indicate the validity of
the test just made.
spirotel shows various messages to help you understand
the reliability of the test you carried out.
To pass from one message to another just press the keys 0
or 2.

spirotel memorises the best PEF and best FEV1 from each
test. If in the course of a single test session both of these



                                                                                         27
parameters reduce with each successive test then the
following warning is shown:

                    ATTENTION !
                    result are falling-off

spirotel memorises the best PEF and the best FEV1
measured in the course of one full day.
If during a test both of these parameters fall by more than a
certain percentage set by your doctor (generally 15%) with
respect to the best daily values, then the following comment
is shown:

                    ATTENTION HIGH
                    VARIABILITY

If a reduction greater than this percentage is not found then
the PEF and FEV1 values are compared to the best values
of the previous day. If this reduction greater than the
programmed percentage is found then also in this case the
variability warning message is shown, otherwise the
machine passes to the next comment.

If the start of the forced expiration test is not carried out
correctly (not blown with enough force) the following
message will be shown:

                    REPEAT test and


28
                     start faster

If the flow falls by over 50% and then increases again during
the first second of the forced expiry then the following
message is shown:

                     REPEAT avoiding
                     coughing

After these (possible) messages the display of the spirotel
shows:
                    12/09 15:28 30%
                    FEV1 5.12 Pf 746

The values shown on the first line indicate the date and time
of the test, the percentage refers to the result compared to
the reference value imposed by the doctor.
On the second line the FEV1 value measured in litres and
the PEF value measured in litres per minute.
The symbol “ ” between the FEV1 value and the text “Pf”
(PEF) indicates that the test has been carried out after a
drug has been taken (for example a broncodilatator).

Press the 0 and 2 keys to view the messages and the results
of the test just carried out.Then press key 2
of the average values obtained in all tests over the last ten
days is shown.
It is possible to view the graph directly by pressing the key 1.


                                                             29
                     PEF
                      453

 PEF  indicates that the graph uses as a reference the PEF
       normal values
* PEF indicates that the graph uses as a reference the PEF
       personal reference values programmed by the
       doctor.
 FEV1 indicates that the graph uses as a reference the
       FEV1 normal values
* FEV1 indicates that the graph uses as a reference the
       FEV1 personal reference values programmed by the
       doctor.

Each point on the graph indicates a shift of the daily average
value compared to the programmed reference parameter. A
central position indicates that the average value is similar to
the reference value (green traffic light). The more the
position of this line rises then the higher the average daily
value is above the reference value. If instead the position of
this line falls below the middle point this means the average
daily value is below the reference value (yellow or even red
traffic light).
The average daily values are calculated on all tests made
during a whole day, including the tests made after a drug
has been taken. When a graph is shown a cursor flashes,
the last dash on the right on the display.


30
Pressing

possible to pass to the following day.
The number shown on the right on the display is the daily
average value of the current position of the cursor.
Pressing the key 1 it is possible to change the various
display information as follows:


 display average PEF value and respective graph

 display the calculated average data,

 display the FEV1 value and respective graph

 display the calculated average data,

 display all test results stored in the memory.

To carry out a new spirometry test press ""

The following message is then shown:

                    BATTERY
                    Make Test N° 2

Repeat the procedure by carrying out the spirometry test as
before.
If the test is carried out correctly the following message is
shown on the display :

                    GOOD! Test



                                                          31
                     is finished

At this point the spirotel switches itself off automatically.
If instead the test is not carried out correctly a message is
shown asking you to carry out another test. These
messages guide you to make two reproducible tests.
If the test is carried out correctly, the spirotel switches itself
off and stores the test data.




32
3.     TRANSMITTING DATA

To transmit spirometric data to the computer of your doctor
spirotel provides three different possibilities:

 Data transmission via telephone
 Data transmission via (GSM) mobile phone
 Data transmission via modem

NOTE:
If the data transmission failed because of an interruption, this will be indicated on the next
switch-on of the spirotel.

3.1          Data transmission via telephone

NOTE:
In order to transmit the data correctly, it is important
to follow the relevant instructions carefully.

 Place the spirotel on an even
  surface.
 During      the  transmission
  avoid any noise and remain
  in silence.
 During the data transmission,
  avoid touching or moving the spirotel and the
  telephone handset.




                                                                                          33
 Before starting the transmission, make sure that you
  are familiar with the process, so that there are no
  delays in the sequence.

NOTE:
The “START TX” button on the downside of the spirotel has exactly the same function
of the “” key.

When your doctor informs you by telephone to start
transmitting the data, proceed as follows:

 Put the spirotel upright on its right side.
 Place the microphone of the telephone (i. e. the part of
  the telephone handset connected to the telephone cable)
  near to the area of the spirotel with a design of the
  telephone handset. The small hole where the signal exits
  should fit near (opt.: 2 - 5 cm) to the hole of the
  microphone of the telephone handset.




34
NOTE:
If necessary, the distance between spirotel and telephone handset can up to about 1 meter,
depending on the ambient noise, but remember that the closer the small hole, where the
signal exits, fits to the handset, the more secure is the data transmission. For a reliable
transmission a distance of a few centimetres is recommended.

 To start the data transmission press “” on the
  keyboard. If the spirotel is switched off, it will switch on
  automatically and a series of beeps will be heard, which
  indicates the start of the data transmission.
 Wait until the data transmission of the spirotel is
  complete, so no sound is heard.
 At the end of transmission the spirotel switches itself off.
 Ask the doctor if the data has been received correctly, if
  not repeat the transmission.

NOTE:
To start the data transmission in alternative to “” key, press the “START TX”
button on the underside of the device.

3.2         Data transmission via (GSM) mobile phone

NOTE:
If your physician has programmed the telephone number to which the data must be sent, the
spirotel will dial this number automatically. Otherwise, the number must be dialled
manually before starting the data transmission.




                                                                                       35
 For connecting the devices, please refer to the following
  diagram.
 Connect your device to the mobile phone, using the
  spirotel interface cable.
  The RS232 connection port is situated on the right side
  of the spirometer.
 Make sure that the mobile phone is switched on and
  ready for operation (battery status, signal strength etc.)
 On request of the doctor to transmit the data, press the
  “” key to initiate the data transmission. If the spirotel
  is switched off, it will switch on automatically and then
  the data transmission begins.
 Having finished the transmission, the spirotel switches
  itself off.
 Ask the doctor if the data has been received correctly, if
  not repeat the transmission.




If the short cable (about 30cm) specially made for
connecting the spirotel to a mobile phone is not available,
connect the spirometer with the mobile phone by using a


36
common RS232-interface cable, a nullmodem-adaptor, a
serial converter and the mobile phone’s data cable.




NOTE:
In case of a busy telephone line or in any other case of failed data transmission, spirotel retries
automatically after a short time.




                                                                                              37
3.3         Data transmission via modem

NOTE:
If your physician has programmed the telephone number to which the data are to be sent,
then spirotel dials this number automatically. Otherwise, the number must be dialled
manually before starting the data transmission.

 For connecting the devices, please refer to the following
     diagram.
   Connect your spirotel to the modem, using the RS232
     connection-port which is situated on the right side of the
     spirometer.
 Make sure that the modem is properly connected to the
     mains supply.
 Make sure that the connection-cable properly connects
     modem and spirotel, including the nullmodem-adaptor.
   Make sure that the modem is properly connected with
     the phone network.
 Make sure that both are switched off, spirotel and
     modem.
 On request of the doctor to transmit the data, switch on
     the modem. The modem will automatically switch on the
     spirotel and start the data transmission. If the spirotel
     remains off, switch it on manually as usual, by pressing
     the "" key.
 Having finished the transmission, the spirotel switches
     itself off.




38
 Ask the doctor if the data has been received correctly, if
  not repeat the transmission.




NOTE:
In case of a busy telephone line or in any other case of failed data transmission, spirotel
retries automatically after a short time.




                                                                                       39
4.          MAINTENANCE

spirotel requires very little maintenance. The only periodic
requirements are:
 Cleaning and general control of the turbine flow and
   volume measuring system.
 Periodic changing of the operating battery.

4.1         Cleaning and general control of the turbine

The turbine flow and volume measurement system used by
the spirotel guarantees accurate measurement and also
has the major advantage of not requiring any periodic
calibration. In order to ensure the correct operation of the
turbine it is necessary to carry out a simple cleaning. This
operation also assures a level of hygiene for the subjects
who will breath through the machine.

NOTE:
It is a good rule to make a visual check from time to time that dirt or foreign bodies are not
deposited inside the turbine, like hair for instance. Any such deposit could slow or block the
free movement of the turbine blade and thus compromise the measurement accuracy.

To clean the turbine first remove it from the machine by
rotating it and then pulling it gently, holding it by the
mouthpiece. It can help to push it gently with a finger from
underneath.




40
Immerse the turbine in a sterilising liquid (not hot), and move
it in the liquid in order to remove any impurities deposited.
Then rinse the turbine immersing it in clean water (not hot).
ATTENTION:                                    !
  To avoid permanent damage do not put the turbine under a direct jet of water or other
  liquid. If no sterilising liquid is available it is necessary to clean the turbine in clean
  water.

Leave it to soak for at least one hour. Shake off the excess
water from the turbine and leave it to dry standing it vertically
on a drying surface.

To check the perfect functioning of the turbine, before
reinserting it inside the machine it is good practise to make a
visual check that the mobile part moves freely. Place the
turbine horizontally and move it slowly from side to side, the
mobile part (blade) must move without any obstruction. If
this is not the case, the accuracy of measurement is no
longer guaranteed and the turbine must be replaced.

When the turbine is clean replace it in the spirotel note the
correct direction as indicated by the “arrow” ( ) printed on
the spirotel case. Twist to lock the turbine into the case.
NOTE:
To insert the turbine correctly in the machine, push it inside until you hear a “click” which
confirms that the turbine is locked inside the plastic case. Twist to lock the turbine into the
case.


                                                                                           41
4.2         Changing the battery

When ''BATTERY LOW'' appears on the display of the
spirotel at switch on, or if the machine does not switch on at
all, then change the operating battery.

NOTE:
Only use 3V Lithium battery CR123A or equivalent.
When you insert the battery pay close attention to the polarity +/- shown inside the battery
cover (see design below)




42
5.      POSSIBLE PROBLEMS

A list of possible problem follows plus a list of messages
which may appear on the display to indicate the type of
problem:

5.1     Causes and solutions

 spirotel does not switch on
Check that the battery is inserted correctly inside the battery
cover on the back of the machine. If this is the case, change
the battery.
 When switched on the display shows 16 dark blocks
Change the battery. If this does not resolve the problem,
contact a qualified technical service company.
 During operation the machine switches itself off and
then on again.
Change the battery. If this does not resolve the problem,
contact a qualified technical service company.
 At the end of a test the measured data is not correct
Clean the turbine and then control the free movement of the
turbine blade.
 Memory lost caused by unexpected event
The data in the archive has been cancelled. Contact a
qualified technical service company.




                                                            43
6. MEASURED PARAMETRES

FET     Forced expiratory time                       s
FEV1    Volume expired in the 1st second of test     L
FEV1%   FEV1/FVC x100                               %
FVC     Forced Vital Capacity                        L
PEF     Expiratory peak flow                       L/s
2575    FEF2575 average flow 25%-75% of FVC        L/s




44
                                 srl MEDICAL INTERNATIONAL RESEARCH
             Via del Maggiolino, 125 00155 Roma - ITALY

                         Declaration of EC Conformity

Quality Management System according to the requirements of Annex II of the Medical
Device Directive 93/42/EEC

Notified body CERMET N° 0476 - Certificate of Conformity N° MED – 9826


MIR srl Medical International Research declares that the Device subject of this
declaration together with its standard accessories conforms to the requirements of the
Council Directive 93/42/EEC
Annex II point 3.


Device Description     Spirometer
Device name            spirotel
Classification         IIa

This device is marked with

Any modifications to the Device which are not authorised by us will invalidate this
declaration.

Roma 11 / 09 / 2000

Signature:                                              Signature:
Simon Fowler                                            Marco Pennacchietti
Sales Manager                                           Quality Manager




Rev. 2 – Mod. PO-10DDC_spirotel




                                                                                  45
               Limited Warranty Conditions

This MIR product together with its standard accessories is
guaranteed for a period of ONE YEAR from the date of
purchase. In the case of any warranty claims the relevant
sales invoice (or another proof of purchase document) must
be submitted to MIR.

The instrument must be checked at the time of purchase and
any claims must be made immediately in writing to MIR.

This warranty covers the repair or the replacement (at the
discretion of the manufacturer) of the product or of the
defective parts without charge for the parts or for the labour

All batteries and other consumable parts are specifically
excluded from the terms of this guarantee.

The warranty is not valid, and the judgement of the MIR
technicians is final, in the following cases:

 If the fault is due to an improper installation or operation
  of the machine, or if the installation does not conform to
  the current safety norms in the country of installation.
 If the product is utilised differently from the use described
  in the Users Manual.
 If any alteration, adjustment, modification or repair has
  been carried out by personnel not authorised by MIR.



46
 If the fault is caused by lack of or incorrect routine
  maintenance of the machine.
 If the machine has been dropped, damaged or subjected
  to physical or electrical stress.
 If the fault is caused by the mains or by another product
  to which the instrument has been connected.
 If the serial number of the instrument is missing,
  tampered with and/or not clearly legible.

The repair or replacement described in this warranty is
supplied for goods returned at the customers expense to our
certified service centre. For details of these centres please
contact your supplier of the spirometer or contact the
manufacturer directly.

The customer is responsible for the transportation and for all
transport and customs charges for the delivery of the goods
both to and from the service centre.

Any instrument or accessory returned must be accompanied
by a clear and detailed explanation of the defect or problem
found. If units are to be returned to the manufacturer then
written or verbal permission must be received before any
instruments are returned to MIR.

MIR reserves the right to modify the instrument if required,
and a description of any modification made will be sent
along with the returned goods.
File ref: Warranty.doc Rev 0 06.05.98



                                                           47

				
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