Ebrington Medical CareFusion MicroLoop User manual

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MicroLoop
Operating Manual – English

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Contents
I. Introduction – English........................................................ 6
Overview.......................................................................... 9
Getting started ................................................................10
Calibration Check .............................................................15
Customisation..................................................................17
Administration Mode.........................................................18
Printing...........................................................................19
PC connection using SPCS .................................................19
Cleaning the Transducer....................................................21
Servicing.........................................................................22
Consumables/ supporting products.....................................23
Specification of the MicroLoop............................................24

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MicroLoop
Operating manual
I. Introduction ,English
The MicroLoop is a mains/battery operated portable spirometer with
the unique combination of ease of use and sophistication. Ease of
use is assured through the use of context sensitive help screens,
accessed at a touch of a button, that explain every MicroLoop
feature. The MicroLoop is supplied with a cradle that may be
connected with the USB cables supplied, to either a PC or a printer.
The cradle also connects to the mains adapter so that the
MicroLoop’s batteries may be charged whilst it is placed in the
cradle. The blue lights on the cradle indicate that it is being
powered either by a PC connection or by the mains adapter. When
either of these sources of power is connected to the cradle, it is
ready to charge your MicroLoop.

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The MicroLoop 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. The transducer is insensitive to the effects
of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Test results may be uploaded to a PC using Spirometry PC Software
and patient details may be downloaded to the MicroLoop.

8
When the unit is turned on for the first
time the system customise menu is
displayed. Touch the name of the
required region with the stylus stored on
the left hand side of the unit and then
touch ‘Finish’. This will set the regional
defaults including language, if available.
If this screen is not displayed then touch
the ‘Customise’ icon on the main menu
followed by the ‘System’ icon.

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Overview
The MicroLoop uses a touch screen with
icons representing each function
available. A stylus, housed in the left
hand side of the unit, is provided for icon
screen activation and an optional mouse
is available.
Touch the displayed time to adjust time
and date.
Unused icons may be disabled by
touching the blue background and
selecting from the list displayed.
Touch the toolbox icon to adjust volume
and brightness.
Four levels of battery charge are
indicated by the segmented battery icon.
When this icon turns red the battery is
nearly exhausted and the batteries must
be charged – see Charging Procedure.
The complete functionality is described on
the help screen.
This is obtained by pressing the help
button (?).
Help text exists for every screen viewed
during the operation of the MicroLoop.
You are recommended to make full use of
the extensive Help screens provided.

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Getting Started
When performing a spirometry test the
recommended workflow is to enter the
patient’s details, or retrieve them from
memory, perform the required test and
then print and save the results.
Please ensure that the turbine transducer
is plugged in to either of the first two
sockets on the right hand side of the
instrument.

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Touch the ‘Patients’ icon to enter the
patient database. The required patient
may be selected from the stored patient
list. If the patient details have not been
previously stored then touch Add to enter
the new patient’s details. The patient
details may also be downloaded from the
optional SPCS software.
Once selected, the patient’s name will
appear at the bottom of the screen.
Use the help button to obtain further
information.
To add a patient to the database use the
on screen keyboard to type a unique
patient ID and then touch the enter key.
You will then be prompted for Last Name,
First Name, Sex, Ethnic Origin, Height,
Weight, date of Birth and Factor. A factor
can be applied when testing individuals of
other ethnic origins who would not
normally be tested against the countries
set of predicted values eg ECCS predicted
values are used but Non Caucasian
individuals tested. The factor alters the
predicted value set on volume indices by
the percentage applied.

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The following factors are recommended when using ECCS normal
values:
Hong Kong Chinese 100%
Japanese American 89%
Polynesians 90%
North Indians and Pakistanis 90%
South Indians and those of African descent 87%
Ref: Lung Volumes and Forced Ventilatory Flows. P.H.Quanjer et al.
Eur Respir J, 1993, 6, Suppl. 16p5:40
Once all the patient details are added the
patient is added to the database and the
main menu is displayed with the patient
name displayed at the bottom of the
screen. From the main menu select the
required test, by touching the icon with
the stylus. If the displayed patient is not
required for testing then touch the
patients name and options to change or
remove the current patient will become
available

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If Relaxed Spirometry is selected then a
volume/time graph will be displayed.
Note that the unit may be customised to
perform a relaxed Vital Capacity with tidal
breathing or from a single expiration or
single inspiration.
When a manoeuvre has been obtained
touch ‘Results’ to view the indices, ‘Again’
to repeat the manoeuvre, ‘Reject’ to
delete the manoeuvre or ‘Done’ to end
the test.
All the active indices are displayed for
any of the manoeuvres selected together
with an option to review the volume/ time
curves. The active indices listed can be
changed by using the customisation
option.
Select ‘Done’ to proceed to the
Spirometry Main Menu.

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From this menu the results of the test
may be viewed, saved, or printed and
notes may be added.
It is also possible to proceed to a forced
baseline spirometry test, or a post
medication relaxed spirometry test.
Select ‘Exit’ when all the required
functions have been used.
If forced spirometry is selected the
default graph will be displayed. This may
be changed by touching the arrows at the
top of the screen. Flow/Volume,
Volume/time or child incentive default
displays may be selected using the
customise option from the main menu.
When the spirometry manoeuvre has
been completed options to repeat the
test, reject the test, and view results will
be available.
At the end of the test options to view
results, save results, print results, and to
add notes will be available from the
spirometry main menu.

15
Calibration Check
Connect a 3 litre syringe to the
transducer with the adapter supplied and
empty by pushing the handle fully in.
Select ‘Calibration Check’ from the main
menu and then select ‘check Calibration’.
Fill the syringe by pulling the handle at a
constant rate until the end stop is
reached and then immediately empty the
syringe completely. Try to maintain a
flow rate that keeps the trace within the
grey bands on the display.
Press ‘Reject’ to retry the calibration
check at the required flow rate.
Press ‘Again’ to repeat the calibration
check at a low flow rate.
Press ‘Again’ to repeat the calibration
check at a high flow rate.
When a calibration check at all three flow
rates has been completed press ‘Done’ to
view the calibration check report screen.

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The calibration error for expiration and
inspiration at each flow rate are
displayed. The calibration error should
be less that 3%. If a greater error is
shown, repeat the procedure ensuring
that the syringe is emptied and filled in a
smooth manner without jerking the
handle. If an error greater than 3% is
still shown, inspect the turbine
transducer and clean if necessary.

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Customisation
The ‘Customise’ option from the main menu may be used to
configure many of the features of your MicroLoop and are divided
into system and spirometry options.
System options allow you to configure the following:
Language.
Height and weight units.
Date format.
Date separator.
Colour or monochrome printing (on external printer).
Personalised printout heading.
Spirometry options allow you to configure the following:
Relaxed spirometry mode (with or without tidal breathing).
Predicted value sets.
Predicted area or line display.
Display default.
Incentive display type.
Printed graphs.
Best test criteria
Interpretation and Lung Age indication.
Dyspnoea score and smoking status.
Daily calibration reminder.
Manual temperature adjustment.
Indices selection.
Note that when the language is selected, the height and weight
units, date format, and date separator will be automatically
changed. However this automatic selection may be overridden
manually.

18
Administration Mode
Administration mode allows the
administrator to restrict the availability
of functions to the user by disabling
icons on the main menu. For example,
after the unit has been configured to
the administrator’s requirements,
disabling of the ‘Customise’ icon will
prevent any further adjustment by the
user. Similarly, disabling of the
‘Database Management’ icon will
prevent the user from deleting any
patient details or test results.
To enter administration mode turn the
unit on whilst holding down the help
key. The default access code is 0000.
Type this number in using the on:screen
keyboard. A number of functions are
now available.
Touch the ‘Change Access Code’ icon in
order to enter your personal access
code and thereby restrict the use of
administration to authorised personnel.
Press the help button to obtain a full
description of the functions.

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Printing
Using the cables provided connect the mini USB A/B socket on the
back of MicroLoop cradle to the input socket on the printer. For a list
of compatible printers refer to the web site or contact your local
dealer
It is recommended that during printing the batteries are placed on
charge with the cradle connected to the mains adapter.
NOTE: Keep the printer out of reach of the patient at all times.
Charging Procedure
The MicroLoop’s internal batteries are discharged when shipped from
the factory and should be fully charged on first use. Plug the AC
adapter into the mains supply and plug the adapter output plug into
the power input socket on the cradle. The orange charging light on
top of the unit will flash to indicate charging and will turn on
constantly to indicate full charge. The blue lights on the cradle will
also be illuminated.
The batteries will take approximately 4 hours to become fully
charged.
Note: Use only the AC adapter supplied. Use of any other type may
cause permanent damage to the MicroLoop and cause a fire or
electrical hazard. Do not plug in and remove the power lead from
the AC adapter repeatedly.
PC connection using SPCS
SPCS is an easy to use PC based windows application that interfaces
to the MicroLoop via a USB or serial port. It incorporates a database
into which patient details can be entered and downloaded to the
MicroLoop or test results may be uploaded from the MicroLoop to
the PC.

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Using SPCS and the MicroLoop, live blows can be performed with the
PC directly controlling the operation of the MicroLoop.
The results and graphs produced are displayed directly on the PC
screen.
The spirometer is connected from the serial or USB port on the PC,
to the USB port on the cradle using the USB cable provided with
SPCS.
Note: The MicroLoop 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’.
Keep the PC out of reach of the patient at all times.
It is recommended that whilst the unit is connected to a computer
the MicroLoop remains in the cradle.
Looking after your Spirometer
Please observe the following precautions:
Do not touch the screen with fingers. Use only the stylus
provided.
Use only a damp, lint free, cloth to clean the screen.
Do not keep the spirometer in a damp place or expose it to
extremes of temperature.
Do not direct the transducer holder towards a strong light
source whilst operating the spirometer.
Check the AC charger for compatibility with local power rating.

21
Cleaning the Transducer
The transducer requires no routine maintenance or servicing.
However, if you wish to disinfect or clean the transducer it may be
removed by means of the following procedure:
1. Rotating the turbine transducer anti:clockwise until the locating
pip lines up with the small rectangular cut:out in the housing as
shown below.
2. Gently pull the transducer away from the housing.
3. The transducer may now be immersed in warm soapy water for
routine cleaning or immersed in cold disinfecting solutions e.g.
Perasafe for a maximum of 10 minutes (Alcohol and chloride
solutions should be avoided). After cleaning/disinfecting, the
transducer should be rinsed briefly in distilled water and dried.
Perasafe is available from CareFusion in convenient 81g
containers, Cat No. 36:SSC5000A.
4. Re:assemble the mouthpiece holder.
Turbi
ne
transducer
Housing
Cut:out
Locating pip

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Servicing
There is no routine maintenance required for the MicroLoop and
there are no user serviceable parts in this instrument. Please return
the unit to CareFusion or an authorised agent if servicing is required.
Troubleshooting
In the unlikely event that the display ‘freezes’ and the unit does not
respond to any key presses, hold the on/off button down for 10
seconds until the unit switches off and then turn on again.
Symbols
Type B device
0086
In accordance with Directive 93/42/EEC
Disposal in compliance with WEEE
Environment
This instrument complies with directive EN60601:1:2
electromagnetic compatibility but can be affected by cellular phones
and by electromagnetic interference exceeding levels specified in
EN 50082:1:1992
This instrument is not for use with flammable anaesthetic gases or in
an oxygen enriched atmosphere
Electrical classification
Class I equipment.

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Consumables/supporting products
Cat. No. Description
36:PSA1000 Adult Disposable Mouthpieces (500 per box)
36:SST1000 One:way Safety Mouthpieces (500 per box)
36:SST1250 One:way Safety Mouthpieces (250 per box)
36:PSA1200 Paediatric Disposable Mouthpieces (250 per box)
36:PSA1100 Paediatric Adaptor
36:MGF1025 MicroGard Pulmonary Filters (25 per box)
36:MGF1100 MicroGard Pulmonary Filters (100 per box)
36:SSC5000A PeraSafe Sterilising Powder 81g
(to make up 5 litres of solution)
36:VOL2104 Nose Clips (pack of 5)
36:SM2125 3 Litre Calibration Syringe
36:SPC1000 Spirometry PC Software
Caution
Pulmonary filters are single patient use. If used on more than one
patient there is a risk of cross:infection. Repeat use may increase
air resistance and lead to an incorrect measurement.”
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.”