User Manual
110 Pages
Preview
Page 1
Foreword
Chapter 1 Foreword 7
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.
8 Pony graphic
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
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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.
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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
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
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Pony graphic
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: [email protected] 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
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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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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. 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.
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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.
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.
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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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Pony graphic
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 .
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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
Parameter
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
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
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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Pony graphic
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 Print 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: Chapter 1 Foreword
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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