Sibelmed DATOSPIR MICRO A Manuel utilisateur
DATOSPIR MICRO
511-A00-MU2 • REV. 2.06 • 2019-03
USER MANUAL
SPIROMETER
DATOSPIR MICRO User’s Manual
2
SIBEL S.A.U., Rosellón 500 bajos, 08026 BARCELONA (Spain)
International Sales:Tel. +34 93 436 00 07
Technical service: Tel. +34 93 433 54 50
Fax: +34 93 436 16 11, Website: www.sibelmed.com
Index
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INDEX
SAFETY .............................................................. 9
1.1 INTRODUCTION ............................................16
1.2 PRELIMINARY OBSERVATIONS ........................17
1.3 DATOSPIR MICRO SPIROMETER MODELS..........18
1.4 LAYOUT OF CONTROLS, PILOT LIGHTS AND
CONNECTORS ....................................................22
1.5 INSTALLATION AND START-UP ........................24
1.6 OPERATING MODES.......................................28
2. MODELS A ................................................... 31
2.1 FUNCTION TREE ...........................................32
2.2 EQUIPMENT CUSTOMISATION.........................36
2.3 EQUIPMENT PROTECTION ..............................40
2.4 FORCED VITAL CAPACITY «FVC» TEST PROCEDURE
41
2.5 SLOW VITAL CAPACITY «VC» TEST PROCEDURE 61
2.6 PROCEDIMIENTO DE LA PRUEBA DE 2.6 MAXIMUM
VOLUNTARY VENTILATION «MVV» TEST PROCEDURE62
2.7 POST BRONCHIAL DILATOR SPIROMETRY
SPIROMETRY PROCEDUR .....................................65
2.8 CALIBRATION PROCEDURE.............................68
2.9 INTERNAL DATABASE ....................................74
2.10 MAINTENANCE PROGRAMME.........................78
2.11 UPDATING INTERNAL SOFTWARE ..................85
2.12 PATIENT OPERATIONS..................................89
3. MODELS B AND C ......................................... 97
3.1 FUNCTION TREE ...........................................98
3.2 EQUIPMENT CUSTOMISATION....................... 103
3.3 EQUIPMENT PROTECTION ............................ 110
3.4 FORCED VITAL CAPACITY «FVC» TEST PROCE.112
3.5 SLOW VITAL CAPACITY «VC» TEST PROCE...... 130
3.6 «MVV» TEST PROCEDURE ............................ 132
3.7 POST BRONCHIAL DILATOR SPIROMETRY
PROCEDURE .................................................... 134
Index
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3.8 CALIBRATION PROCEDURE........................... 138
3.9 INTERNAL DATABASE .................................. 144
3.10 MAINTENANCE PROGRAMME....................... 151
3.11 UPDATING INTERNAL SOFTWARE ................ 157
3.12 PATIENT MODE OPERATION ........................ 161
4. COMMUNICATIONS .................................... 171
4.1 TRANSFERRING EQUIPMENT CHEQUE DATA AND
DATABASE DATA............................................... 172
4.2 PATIENT TEST MANAGEMENT IN THE PC ........ 174
4.3 EXPORTING TESTS TO OTHER SYSTEMS......... 175
4.4 SPIROMETRY SOFTWARE W-20 FOR PC .......... 176
5. TECHNICAL ............................................... 177
5.1 TYPES OF TEST, FUNCTIONS AND PARAMETERS ...
178
5.2 MEASURING SYSTEM................................... 183
5.3 MICRO CONTROLLER ................................... 184
5.4 PRESENTATION OF DATA.............................. 185
5.5 TEMPERATURE SENSOR ............................... 185
5.6 GENERAL DATA........................................... 185
6. OPERATING PRINCIPLES ........................... 193
6.1 TURBINE.................................................... 194
6.2 TURBINE ROTATION SENSOR........................ 194
6.3 MICROPROCESSOR ..................................... 195
7. SPIROMETRY TECHNIQUE .......................... 199
7.1 PROCEDURE............................................... 200
7.2 CALIBRATIONS ........................................... 201
7.3 VALUES OF REFERENCE FOR FORCED SPIROMETRY
«SEPAR» ......................................................... 203
7.4 VALUES OF REFERENCE FOR FORCED SPIROMETRY
«ECCS.93» ...................................................... 205
7.5 OTHER VALUES OF REFERENCE..................... 206
8. UPKEEP, PREVENTATIVE AND CORRECTIVE .....
MAINTENANCE .............................................. 207
8.1 UPKEEP ..................................................... 208
Index
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8.2 PREVENTATIVE MAINTENANCE...................... 210
8.3 CORRECTIVE MAINTENANCE......................... 211
APPENDIX 1..................................................... 213
ELECTROMAGNETIC ....................................... 213
COMPATIBILITY ............................................ 213
APPENDIX 2 .................................................. 219
Index
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DATOSPIR MICRO User’s Manual
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Declaration of Conformity
511-A00-MU2 • REV. 2.06
The DATOSPIR MICRO Spirometer has been designed by the
SIBEL, S.A.U. R&D&i Department, with the cooperation of the
Hospital de la Santa Creu y Sant Pau Pulmonary Function
Laboratory in Barcelona, in line with the standardisation criteria
of International Institutions: ATS/ERS TASK FORCE (American
Thoracic Society/ European Respiratory Society) and National
Institutions: SEPAR (Spanish Neumology and Thoracic Surgery
Society).
Revised Approved
Date: 2019-03Date: 2019-03
Antoni Picó Albert Grau
Technical Director Sales Director
PRODUCT CONFORMS WITH
93/42/CEE Medical Devices Directive. Class II a
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Declaration of Conformity
511-A00-MU2 • REV. 2.06
Safety
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511-A00-MU2 • REV. 2.06
SAFETY
SPECIAL PRECAUTIONS
The DATOSPIR MICRO spirometer has been designed for use
with the utmost safety. All operating instructions must be read
before using the DATOSPIR MICRO. Not doing so may lead to
injuries to the user or the patient and damage to equipment and/
or accessories.
INTENDED USE
The spirometer measures and calculates a series of parameters
related to the human respiratory function.
The spirometer is not designed for use outdoors or under other
conditions or using other power sources not indicated in this
manual.
The spirometer is not intended to be used in transport vehicles.
It is advisable to use the device in an acoustic environment
enough silent to allow the patient make the manouvers correctly
and hear the acoustic warnings.
The device must be located in a safety position. This avoids it
falls down and consequently any failure to the device or damage
to patient and/or user.
In hospital mode, the DATOSPIR MICRO is a complete spirometer
and users may fully congure the instrument.
In patient mode, patients may only switch the equipment on, blow
and switch it off. The doctor must have previously congured the
equipment and instructed the patient.
USER PROFILE
Prole of technical specialist or doctor.
Safety
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The spirometer is designed to be used by medical staff only,
being supervised by a physician. Specic training in spirometry
is recommended.
User must be familiarized with the functioning of the device before
beginning to perform tests with patients.
All necessary information can be found in the user’s manual.
For more information, consult SIBEL S.A.U. or your regular
distributor.
Prole of the patient
Age:> 4 years until old age
Weight:> 10 Kg
Height:> 50 cm
Health status: physical and mental condition that allows the
completion of the forced expiratory maneuver.
EFFECTS ON PATIENTS USING THE SPIROMETER
The spirometry tests require patient cooperation.
Complete forced expiration is required to obtain signicant patient
FVC values. The doctor must assess the patient’s capacity to
undertake spirometry tests. Special attention must be paid to
children, the elderly and the disabled.
LIMITATIONS OF USE. CONTRAINDICATIONS
An analysis of the results of a spirometry tests is not enough in
itself to give a correct diagnosis of the patient’s clinical condition.
The patient’s records and any tests that the doctor believes
necessary must therefore also be considered.
A doctor must interpret the tests and any treatment provided
as a result.
The patient’s symptoms must be taken into account by medical
staff before any spirometric test is undertaken.
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