Cosmed Pony graphic User Manual

Chapter 1 Foreword 7

Foreword

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 hap-

pened 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

8 Pony graphic

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.

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

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

10 Pony graphic

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.

Chapter 1 Foreword 11

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

• 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

12 Pony graphic

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 13

14 Pony graphic

Chapter 1 Foreword 15

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: [phone]
fax: [phone]

E-mail: [e-mail]
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

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.

16 Pony graphic

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.

Noti ce: 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 17

Conventions

Here are the conventions used for its draft.

Typographic conventions

The following typographic conventions are used in this manual:

Type Represents

Bold 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.

"italic" 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 It represents the key to be pressed to execute the pre-

dicted function.

Display It represents prompts and messages on the Pony dis-

play during the execution of corresponding functions.

18 Pony graphic

Features

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.

Keyboard

Graphic LCD

Printer

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.

Chapter 1 Foreword 19

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 Zapletal
IT S IT S
Knudson 83 Knudson83
MC Barcelona MC Barcelona
LAM LAM

20 Pony graphic

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.

Accessories

Here following the list of the main accessories consumables for
Pony graphic.

Accessories/consumables

Description Part Number

Calibration syringe (3 litres) C00600-01-11
Paper mouthpiece for children (500pcs) C01814-01-98
Paper mouthpiece for adults (500pcs) C01805-01-98
Roll of paper (10pcs) C00643-01-98
Printer ribbon (5 pcs) A666 905 001
Nose clips (5 pcs) C00441-01-98

Technical Features

Features Value

Flow meter Digital bidirectional turbine
Flow range 0.03 - 20 l/s
Volume range 10 l
Accuracy F/V ± 3% or ± 50 ml
Dynamic res at 12 l/s < 0.7 cm H2O/l/s
Mouthpieces Ø 31 and 22 mm
Graphic display Back lighting LCD 70x80 mm
Printer Graphic, 24 char/lin, 2,5 lines/s
Keyboard 12 multifunction keys
Serial cable RS 232 bidirectional 4800 baud.
Power supply Batteries Ni-Cd 5V, 1,2 Ah
Battery autonomy 200 tests including prints out
Battery charge 12V dc - 1,2 A
Dimensions 237x127x46 mm
Weight 1,2 kg

PC configuration required

• Pentium 133 MMz.

• Windows 95, 98, NT.

• 16 Mb RAM .

Chapter 1 Foreword 21

• 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 Parameter

FVC l Forced Vital Capacity

Best FVC l Best Forced Vital Capacity
FEV1 l Volume exhaled after 1s of the FVC

PEF l/s Peak Expiratory Flow

PIF l/s Peak Inspiratory Flow
Vmax 25% l/s Expiratory flow at 25% of FVC

Vmax 50% l/s Expiratory flow at 50% of FVC
Vmax 75% l/s Expiratory flow at 75% of FVC

FEF25-75% l/s Average expiratory flow between 25% and 75% of

FEV1/FVC% % FEV1/FVC x 100
FET 100 % s Forced expiration time (100% FV)

VEXT ml Extrapolated Volume (back extrapolation)

FVC

22 Pony graphic

VC- IVC Slow Vital Capacity and Ventilatory pattern

Symbols um Parameter

EVC l Expiratory Vital Capacity

IVC l Inspiratory Vital Capacity
ERV l Expiratory Reserve Volume

IRV l Inspiratory Reserve Volume
IC l Inspiratory Capacity

VE l/m Expiratory Minute ventilation
Vt l Tidal Volume

Rf resp/min Respiratory frequency

Te s Duration of expiratory
Ti s Duration of inspiratory

Tto t sec Duration of Total breathing cycle
Vt/ti l/s Vt/ti ratio

Ti /Tt ot l Ti/T tot

MVV- Maximum Voluntary Ventilation

Symbols um Parameter

MVV l/m Maximum Voluntary Ventilation

Bronchoprovocation Response

Symbol UM Parameter

FallFEV1 % Fall in FEV1 from baseline or post diluent

Fall Vmax50% % Fall in Vmax from baseline or post diluent
P1 0 % Provocative dose (or concentrat.) causing FEV1 to

P1 5 % Provocative dose (or concentrat.) causing FEV1 to

P20 % Provocative dose (or concentrat.) causing FEV1 to

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.

fall 10% baseline

fall 15% baseline

fall 20% baseline

Chapter 1 Foreword 23

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.

Noti ce: 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

24 Pony graphic

Chapter 1 Foreword 25

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 inserts anthropometric data and ID Code of a new

patient.

Sex modification of the sex value in the anthropometric

data.
Patient displays and modifies the last inserted patient’s data.

Utility accesses the utility menu.
Print prints out patient’s data or test.

FVC carries out the Forced Vital Capacity test.
VC carries out the Slow Vital Capacity test.

MVV carries out the Maximum Voluntary Ventilation test.
Last displays the last test.

Best displays the best test.
Paper advancing roll of printer paper.

Confirm and cancel commands

The following commands are active during every Pony graphic
functions:

Key Function

Cancel cancels the last operation
Enter 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:

Key Function

Post test selects a reference Pre test for the

execution of the post tests.

Test list printouts or displays the patients’

contents of the archive.

Test search searches for an archived test to dis-

play or print out of the test data or
loops.

Transmit Data allows the data transferring to a PC

or modem.

Erase Archive allows to erase all data of the ar-

chive.

Configure displays the utility menu.

Configure Menu

Pressing the configuration key, the key board is structured as
follows:

Key Function

Calibrate F/V allows the turbine calibration .
Predicted values allows the predicted value selection.
Diagnosis allows to disable or enable the auto-

matic diagnosis.

Units allows the selection of the unity of

measurement.

BTPS allows to calculate the BTPS factor

26 Pony graphic

Chapter 2 Setting up the Pony graphic 27

Setting up the
Pony graphic

Preparing the unit

optoelectronic reader

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.

Pony graphic 28

paediatric mouthpiece

Adaptor

turbine flowmeter

Turbine connection

adults mouthpiece

Chapter 2 Setting up the Pony graphic 29

Internal Printer

To replace the printer ribbon

1. Remove the printer cover.

2. Press the ribbon cartridge down where it says Push.

3. Insert the new ribbon cartridge.

4. 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.

Pony graphic 30

printer ribbon

printer cover

printer paper

Press and push
the cover forward

Chapter 2 Setting up the Pony graphic 31

Power Supply

Once the batteries are fully charged, they allow the execution of
about 200 tests.

When the batteries reaches a lower level, the Pony graphic shows
it with the "Battery" sign on the screen. In this case you can still
use the unit but it's suggested to recharge the batteries.

220V Power supply

Adaptor for car

Connection to the "car lighter
plug"

Connection to the net

The Pony graphic can be supplied by the following ways:

• NI- Cd recharging batteries.

• Connection to 110-220v plug by the proper batteries charger-

• Connection to the “car lighter ”plug.

If the Pony graphic is used when it is connected to the main the
recharging time will be longer.

power supply.

Pony graphic 32

Noti ce: In case of complete battery discharge, the Pony graphic

battery charge led indicator

will lose all data

To charge the batteries

1. Connect the batteries charger or the lighter adapter to a power
supply connector.

2. Connect the batteries charger to a socket, as it is specified on
the batteries charge itself and check that the “charge “ indica­tor is on.

Maximum recharging time is 1 hour and 30 minutes and if the
batteries are not fully discharged the time is shorter. Leaving the
batteries charger connected longer than the maximum charging
time not damage will occur.

Noti ce: It's suggested not to use the pony graphic during the
first minutes of charging.

When the green led indicator of the charger batteries is flashing,
the batteries are charged.

Chapter 2 Setting up the Pony graphic 33

Pony graphic 34

Chapter 3 Using the Pony graphic 35

Using the
Pony graphic

Turning the Pony graphic on

After having connected the turbine Flow Meter, checked if there
is any paper and ribbon in the printer, turn the Pony graphic on:

1. Set the power switch on “I” and the display should show
information about the tests in archive, the free memory and
the message “insert date”.

2. Confirm or modify the date on the display pressing the keys
corresponding to the number to type. For example if you
want to insert the date “ 12.- 07- 1994 “ it is necessary to type
sequential the keys 1, 2, 0, 7, 9 ,4 and press Enter to confirm.

3. Once the date is confirmed with Enter, the main pattern ap­pears on the display.

Pony graphic 36