pony_graphic_user_manual.pdf
Page 1
Foreword
Chapter 1 Foreword 7
Page 2
Important notices
Intended use
Pony graphic is an electrical medical device designed to perform
pulmonary function tests.
It is to be used by physicians or by trained personnel on a physician responsibility.
This equipment has been conceived to be used as an auxiliary
instrument in order to:
• formulate lung pathology diagnosis;
• perform studies concerning human physiology;
• get information in sport medicine.
No responsibility attaches COSMED srl for any accident happened after wrong use of the device, such as:
• use by non qualified people;
• non respect of the device intended use;
• non respect of all the following precautions and instructions.
Warnings
The device, the programme algorithms and the presentation of
measured data have been developed according to the specifications of ATS (American Thoracic Society) and ERS (European
Respiratory Society). Other international references have been
followed when these were not available All bibliography references are reported in manual Appendix.
The present handbook has been developed following the 93/42
CEE requirements, according to which Pony graphic is to be
considered Class IIa device.
It is recommended to read carefully the following precautions
before putting the device into operation.
The precautions reported below are of fundamental importance to
assure the safety of all COSMED equipment users.
1. This user manual is to be considered as a part of the medical
device and should always be kept on hand.
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2. Safety, measure accuracy and precision can be assured only
if:
· are used the accessories described in the manual or given
with the device. Actually non recommended accessories can
affect safety unfavourable. Before using non recommended
accessories is necessary to get in touch with the manufacturer;
· ordinary equipment maintenance, inspections, disinfection
and cleaning are performed in the way and with the frequency
described;
· any modification or fixing is carried out by qualified personnel;
· the environmental conditions and the electrical plants where
the device operates are in compliance with the specifications
of the manual and the present regulations concerning electrical plants.
3. This device is not suitable for use in presence of flammable
anesthetics. It is not an AP nor an APG device (according to
the EN 60 601-1 definitions).
4. Keep the device away from heat and flame source, flammable or inflammable liquids or gases and explosive atmospheres.
5. We recommend to use only the provided battery charger
(P/N C00766-0X-30). Any other charger could damage the
device.
6. According to the intended use of this device, Pony graphic is
not to be used together with other medical devices unless it is
clearly declared by the manufacturer itself.
7. In case the device is to be used with a PC, is recommended to
use a computer with electromagnetic compatibility CE marking and with low radiation emission displays.
8. It is necessary to make the PC, connected to the Pony
graphic, compliants with EEN 60601-1 by mean of an isolation
trasformer.
Chapter 1 Foreword 9
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9. Graphical symbols used in accordance to present specifications are described here below:
Equipment type B (EN60601-1)
Danger: high temperature
OFF
ON
Protective Earth Ground
Alternating Current
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Contraindication
The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology. The following list is not complete and must be considered as a piece of mere
information.
Contraindications for the Spirometer tests
Absolute contraindications
For FVC, VC and MVV tests:
• Post-operating state from thoracic surgery
For FVC tests:
• Severe instability of the airways (such as a destructive bronchial emphysema)
• Bronchial no-specific marked hypersensitivity
• Serious problems for the gas exchange (total or partial respiratory insufficiency)
Relative contraindications
For FVC tests:
• spontaneous post-pneumothorax state
• arterial-venous aneurysm
• strong arterial hypertension
• pregnancy with complications at the 3 mouth.
For MVV test:
• hyperventilation syndrome
Contraindications for Bronchial provocation tests
The bronchial provocation tests must be executed according to
the doctor’s discretion. There are not data that reveal specific
contraindication for the bronchial provocation test through inhalation.
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The modern standard processes have been revealing secure in
several clinical studies. However it is recommendable to respect
the following contraindications:
Absolute contraindications
•
•
•
•
•
Serious bronchial obstruction (FEV1 in adults)
Recent myocardium infarct
Recent vascular-cerebral accident
Known arterial aneurysm
incapacity for understanding the provocation test procedures
and its implications.
Relative contraindications
•
•
•
•
•
•
•
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Pony graphic
Bronchial obstruction caused by the respiratory manoeuvre.
Moderate or serious bronchial obstruction. For ex. Predicted
value FEV1 less than 1.51 in men and predicted value FEV1
in women less than 1.21.
Recent infection in the superior air tracts
During the asthmatic re- acuting
Hypertension
Pregnancy
A pharmacology treatment epilepsy
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Checking the packing contents
The Pony graphic is composed by a Main unit and by some other
accessories.
Make sure that the packing box contains the instruments listed
below. In case of missing or damaged parts, please contact your
nearest COSMED technical assistance.
Pony Graphic standard equipment
The Pony graphic contains the following instruments:
Description
Part number
Quantity
Turbine L89
C00292-01-05
1
Optoelectronic reader
C00095-01-05
1
Mouthpiece adapter for children
C00214-01-20
1
Carrying case
C00109-01-30
1
Paper mouthpiece for adults
C00136-01-20
50
Paper mouthpiece for children
C00137-01-20
50
Nose clips
A662100001
2
Roll of paper
C00643-01-98
2
Printer ribbon
A 666 905 001
2
Power supply 220V 12V 1A
C00766-01-30
1
Batteries charger adapter in car
C00297-01-12
1
Serial cable RS232
C00150-01-12
1
SW_PC Win Pony Graphic
C01335-02-35
1
User manual
C00296-02-91
1
Registration card
C00067-02-94
1
Turbine attention paper
C00169-01-92
Chapter 1 Foreword
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Pony graphic
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Warranty registration
Before operating the system, please fill in the registration form
and send it to COSMED.
To be registered means being entitled to customer’s assistance.
For further information concerning the benefits, please refer to
the registration form.
Contacting COSMED
For further information you may contact the manufacturer directly at the following address:
COSMED S.r.l
Via dei Piani di Monte Savello, 37
P.O. Box 3
00040 - Pavona di Albano - Rome Italy
tel:
+39-06-93.15.492
fax:
+39-06-93.14.580
E-mail: info@cosmed.it
Internet: www.cosmed.it/support
Safety and conformity
Safety
IEC 601-1 (1988)/EN 60 601-1 (1990);
Below is reported the complete classification of the device:
• Class II B device if used with specified power supply or internally powered equipment class B device if used stand
alone.
• Protection against water penetration: IP00, ordinary equipment unprotected against water penetration
• Non sterile device
• Device not suitable in the presence of flammable anesthetics;
• Continuos functioning equipment;
EMC
The system meets the EMC Directive 89/336
EN 60601-1-2
Chapter 1 Foreword
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EN 55011 Class B (emission)
IEC 1000-4-2 (1991, immunity ESD): 4KV CD, 8 KV AD
IEC 1000-4-3 (1984, immunity fields EM): 3 V/m
IEC 1000-4-4 (1988, immunity Burst): 1 KV
Quality Assurance
UNI ISO EN 9001 (Registration n° 387 Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476)
Class IIa.
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Environmental condition of utilization
COSMED units have been conceived for operating in medically
utilized rooms without potential explosion hazards.
The units should not be installed in vicinity of x-ray equipment,
motors or transformers with high installed power rating since
electric or magnetic interferences may falsify the result of measurements or make them impossible. Due to this the vicinity of
power lines is to be avoided as well.
Cosmed equipment are not AP not APG devices (according to
EN 60601-1): they are not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or nitrogen protoxide.
If not otherwise stated in the shipping documents, Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions [IEC 601-1(1988)/EN 60
601-1 (1990)].
• Temperature range 10°C (50°F) and 40°C (104°F).
• Relative humidity range 20% to 80%
• Atmospheric Pressure range 700 to 1060 mBar
• Avoid to use it in presence of noxious fumes or dusty environment and near heat sources.
• Do not place near heat sources.
Notice: if accidentally droppings, exposure to heat source and
excessive humidity may compromise the validity of the system, we
recommend you a calibration check or ask for a technical assistance.
Chapter 1 Foreword
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Conventions
Here are the conventions used for its draft.
Typographic conventions
The following typographic conventions are used in this manual:
Type
Represents
Bold
"italic"
It indicates an item to be selected or a key to be
pressed, in this last opportunity the beginner letter is
always a capital letter.
It indicates, if it is in inverted commas”, the message
showed on the Pony display.
Graphic conventions
The following Graphic conventions are used in this manual:
Symbol Description
Key
Display
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Pony graphic
It represents the key to be pressed to execute the predicted function.
It represents prompts and messages on the Pony display during the execution of corresponding functions.
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Features
Pony graphic, which is represented in the figure below, is a spirometric system to evaluate static and dynamic lung functionality.
Pony graphic allows to download data to a PC through a serial
RS232 connection.
Printer
Graphic LCD
Keyboard
New features
Graphic display
The wide display allows to show in real time the flow/volume
loop during the Forced Vital Capacity manoeuvre and the volume/time loop during Slow Vital Capacity and Maximum Voluntary Ventilation manoeuvre. The back-lighting gives a better
visibility even in conditions of poor lighting.
Chapter 1 Foreword
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Turbine
Due to new helicoidal conveyers, it offers very low resistance to
the flow (< 0.7 cmH2O/l/s at 12 l/s of flow).
Printer
The new High speed Epson printer (2.5 lin/s). Pony graphic provides a complete print out report in few seconds. Pony graphic
enables to print a wide print out meeting the ATS 1987 requirements through an external printer. This feature is compatible with
printers having HP PCL3 printer language and with a serial port.
Test management
It is possible to display and print out tests stored in the archive
even afterwards.
Bronchial provocation response
With the Pony graphic it is possible to display and print out the
fall of FEV1 at the end of each Post test choosing Fall Fev1
command at the end of every FVC post.
Predicted values
By means of the Predicted command of the Configuration menu
it is possible to select the following predicted values:
Adults
Paediatric
ERS 93
ITS
Knudson 83
MC Barcelona
LAM
Zapletal
ITS
Knudson83
MC Barcelona
LAM
Calibration
The calibration process is completely managed by the keyboard.
Automatic diagnosis
The automatic diagnosis can now be enabled or disabled by user.
Supply
The new Ni-Cd batteries (without memory effect) and rapid batteries charger allow to use the Pony graphic even during the batteries charging.
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Accessories
Here following the list of the main accessories consumables for
Pony graphic.
Accessories/consumables
Description
Part Number
Calibration syringe (3 litres)
Paper mouthpiece for children (500pcs)
Paper mouthpiece for adults (500pcs)
Roll of paper (10pcs)
Printer ribbon (5 pcs)
Nose clips (5 pcs)
C00600-01-11
C01814-01-98
C01805-01-98
C00643-01-98
A666 905 001
C00441-01-98
Technical Features
Features
Value
Flow meter
Flow range
Volume range
Accuracy F/V
Dynamic res at 12 l/s
Mouthpieces
Graphic display
Printer
Keyboard
Serial cable
Power supply
Battery autonomy
Battery charge
Dimensions
Weight
Digital bidirectional turbine
0.03 - 20 l/s
10 l
± 3% or ± 50 ml
< 0.7 cm H2O/l/s
Ø 31 and 22 mm
Back lighting LCD 70x80 mm
Graphic, 24 char/lin, 2,5 lines/s
12 multifunction keys
RS 232 bidirectional 4800 baud.
Batteries Ni-Cd 5V, 1,2 Ah
200 tests including prints out
12V dc - 1,2 A
237x127x46 mm
1,2 kg
PC configuration required
•
•
•
Pentium 133 MMz.
Windows 95, 98, NT.
16 Mb RAM .
Chapter 1 Foreword
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•
•
•
•
•
3.5 drive.
VGA, SVGA monitor.
Serial Port RS 232 available ( two serial ports available in
case of Ergometer control).
Any Mouse and Printer compatible with the MS Windows™
operative system.
PC conform to European Directive 89/336 EMC
List of parameters calculated
FVC - Forced Vital Capacity
Symbols
um
FVC
Best FVC
FEV1
PEF
PIF
Vmax 25%
Vmax 50%
Vmax 75%
FEF25-75%
l
l
l
l/s
l/s
l/s
l/s
l/s
l/s
FEV1/FVC%
FET 100 %
VEXT
%
s
ml
Parameter
Forced Vital Capacity
Best Forced Vital Capacity
Volume exhaled after 1s of the FVC
Peak Expiratory Flow
Peak Inspiratory Flow
Expiratory flow at 25% of FVC
Expiratory flow at 50% of FVC
Expiratory flow at 75% of FVC
Average expiratory flow between 25% and 75% of
FVC
FEV1/FVC x 100
Forced expiration time (100% FV)
Extrapolated Volume (back extrapolation)
VC- IVC Slow Vital Capacity and Ventilatory pattern
Symbols
EVC
IVC
ERV
IRV
IC
VE
Vt
Rf
Te
Ti
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Pony graphic
um
l
l
l
l
l
l/m
l
resp/min
s
s
Parameter
Expiratory Vital Capacity
Inspiratory Vital Capacity
Expiratory Reserve Volume
Inspiratory Reserve Volume
Inspiratory Capacity
Expiratory Minute ventilation
Tidal Volume
Respiratory frequency
Duration of expiratory
Duration of inspiratory
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Ttot
Vt/ti
Ti/Ttot
sec
l/s
l
Duration of Total breathing cycle
Vt/ti ratio
Ti/Ttot
MVV- Maximum Voluntary Ventilation
Symbols
um
Parameter
MVV
l/m
Maximum Voluntary Ventilation
Bronchoprovocation Response
Symbol
UM
FallFEV1
%
Fall Vmax50% %
P10
%
P15
%
P20
%
Parameter
Fall in FEV1 from baseline or post diluent
Fall in Vmax from baseline or post diluent
Provocative dose (or concentrat.) causing FEV1 to
fall 10% baseline
Provocative dose (or concentrat.) causing FEV1 to
fall 15% baseline
Provocative dose (or concentrat.) causing FEV1 to
fall 20% baseline
Pony graphic archive
The pony graphic archive can store data from tests conducted on
over 200 patients. Its actual capacity depends on the width (volume axis) of the flow volume loops stored: the flatter the loops,
the greater the number of tests that can be stored.
Pony graphic assigns a progressive number to each new chart
(i.e. paper archive), in which all the data and test results relative
to the new patient are stored. The Pony graphic also assigns an
ID Code number for each patient.
For each patient’s ID code, the best FVC, VC, IVC, MVV and
Post FVC tests can be stored.
The criteria to choose the best tests are:
FVC
the greatest summation value FVC + FEV1
VC the greatest VC value
IVC
the greatest IVC value
MVV the greatest MVV value.
The parameters calculated during the entire test session are
grouped in two categories:
LAST data and loop of the last test executed
BEST data and loop of the best test executed.
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These data are stored until you enter data on a new patient with
New command.
For each patient, only the group of parameters calculated based
on the best tests, is transferred to the archive memory by means
of the key Enter as soon as the execution test is completed.
Notice: all the stored data are saved even when the Pony
graphic is turned off (power switch off) so long as the Ni-Cd
batteries are sufficiently charged.
Archive structure
Patient’s ID Code
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List of commands
Pony graphic is provided with a multifuction keyboard, whose
keys have different meanings in relation to the kind of executing
function.
Function Keys
The main function/keys list is the following.
Key
Function
New
Sex
Patient
Utility
FVC
VC
MVV
Last
Best
Paper
inserts anthropometric data and ID Code of a new
patient.
modification of the sex value in the anthropometric
data.
displays and modifies the last inserted patient’s data.
accesses the utility menu.
prints out patient’s data or test.
carries out the Forced Vital Capacity test.
carries out the Slow Vital Capacity test.
carries out the Maximum Voluntary Ventilation test.
displays the last test.
displays the best test.
advancing roll of printer paper.
Confirm and cancel commands
The following commands are active during every Pony graphic
functions:
Key
Function
Cancel
Enter
cancels the last operation
confirms the operation in progress
Utility menu
Some commands, like the utility and configuration commands,
allow to access other functions.
Pressing the utility key , the keyboard is structured as follows:
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Key
Function
Post test
selects a reference Pre test for the
execution of the post tests.
printouts or displays the patients’
contents of the archive.
searches for an archived test to display or print out of the test data or
loops.
allows the data transferring to a PC
or modem.
allows to erase all data of the archive.
displays the utility menu.
Test list
Test search
Transmit Data
Erase Archive
Configure
Configure Menu
Pressing the configuration key, the key board is structured as
follows:
Key
Function
Calibrate F/V
Predicted values
Diagnosis
Units
BTPS
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Pony graphic
allows the turbine calibration .
allows the predicted value selection.
allows to disable or enable the automatic diagnosis.
allows the selection of the unity of
measurement.
allows to calculate the BTPS factor
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Setting up the
Pony graphic
Chapter 2 Setting up the Pony graphic
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Preparing the unit
Before using the Pony graphic it's necessary:
• set up the turbine Flow Meter
• check the paper in the printer
• check the ribbon in the printer
• make sure the batteries are charged
Turbine
To install the turbine:
1. Connect the turbine flow meter to the Main Unit, by inserting
the 4-pin turbine Flow Meter plug in the slotted jack.
2. Insert the disposable mouthpiece on the turbine flow. Use the
proper mouthpiece adapter for children.
optoelectronic reader
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adults mouthpiece
turbine flowmeter
paediatric mouthpiece
Adaptor
Turbine connection
Chapter 2 Setting up the Pony graphic
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Internal Printer
To replace the printer ribbon
1.
2.
3.
4.
Remove the printer cover.
Press the ribbon cartridge down where it says Push.
Insert the new ribbon cartridge.
Replace the printer cover introducing the paper roll in the
opening on the printer front.
To replace
the printer paper
1. Remove the printer cover.
2. Remove the empty roll.
3. Turn on the system until the message “select a function"
appears on the screen.
4. Insert the roll of paper through the opening towards the rear
of the printer.
5. Press the paper key to advance the roll of paper.
6. Replace the printer cover.
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printer ribbon
printer cover
Press and push
the cover forward
printer paper
Chapter 2 Setting up the Pony graphic
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