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DATOSPIR TOUCH User’s Manual 67

511-B00-MU2 • REV. 1 .09

Annex 1.

ELECTROMAGNETIC COMPATIBILITY

1.1

GUIDANCE & MANUFACTURER’S DECLARATION

Guidance and manufacturer’s declaration – electromagnetic emissions

DATOSPIR TOUCH is intended for use in the electromagnetic environment specified below. The customer or
the user should assure that it is used in such an environment.

Emissions test

RF (Radiated) emissions

CISPR 11 (EN 55011)

Group 1

Class B

RF (Conducted) emissions

CISPR 11 (EN 55011)

Group 1

Class B

Harmonic emissions

EN-IEC 61000-3-2

Class A

Voltage fluctuations / Flicker
emissions

EN-IEC 61000-3-3

Cumple

Содержание DATOSPIR TOUCH DIAGNOSTIC - D

Страница 1: ...DATOSPIR TOUCH SPIROMETER USER S MANUAL 511 B00 MU2 REV 1 09 2019 05...

Страница 2: ...IBEL S A U Rosell n 500 bajos 08026 BARCELONA Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 e mail export sibelmed com Technical service T...

Страница 3: ...4 2 QUALITY OF FVC TEST 44 4 3 POST BRONCHODILATION TEST 47 4 4 SLOW VITAL CAPACITY VC TEST 49 4 5 MAXIMUM VOLUNTARY VENTILATION MVV TEST 50 5 COMMUNICATIONS SYSTEM 51 5 1 TRANSFERRING TESTS TO THE P...

Страница 4: ...f Hospital de la Santa Creu i Sant Pau de Barcelona in line with the standardization criteria of International Institutions ATS ERS TASK FORCE 2005 American Thoracic Society European Respiratory Socie...

Страница 5: ...piratory diagnostic Use in a health center or similar and indoor use not for outdoor use Not intended for home use or for use in moving transport vehicles INDICATIONS FOR USE The spirometer should NOT...

Страница 6: ...to obtain meaningful patient FVC values The clinician administering the test must assess the patient s capacity to perform the spirometry test Special attention must be paid to children the elderly a...

Страница 7: ...k of electric shock this equipment must be connected to a power supply with protective earth only DO NOT tamper with the integrity of the system s electric earth connection Protection against electric...

Страница 8: ...safeguard could be an additional ground conductor connected to the metallic enclosure of the non medical device contact to Technical Support to see if it is practicable or a USB separation device pro...

Страница 9: ...ts must be original and must be requested from the manufacturer or dealer to ensure patient safety and ensuring the proper operation of the spirometer Failure to do so may increase the emissions or de...

Страница 10: ...t module Furthermore the spirometer may be connected in real or deferred time to a PC via USB Bluetooth or Ethernet using the W20s Spirometry software to perform tests download tests results from the...

Страница 11: ...pational and primary care also included Easy Diagnostic D T F D T F TRANSDUCERS Disposable Turbine Fleisch SETTINGS Occupational Medicine Mode Primary care Mode Diagnostic mode 1 000 test internal dat...

Страница 12: ...form FVC and Bronchodilatation tests OC PC DIAG FUNCTIONALITIES FVC VC MVV Bronchodilation Post Bronchoconstriction Alternated V T F V plots Simultaneous V T F V plots Superposed curves Acoustic signa...

Страница 13: ...Sales Department or your dealer 2 2 3 PACKING LIST Easy Diagnostic D T F D T F TRANSDUCERS 1 Disposable 2 Turbine 3 Fleisch ACCESSORIES STANDARD 4 Thermal paper 110x50 5 USB and printer cable connecti...

Страница 14: ...e 3 L 09160 Nose clip 1 u 09152 Plastic Mouthpiece 1u 09037 Disposable mouthpiece pack 25 u 03169 Disposable transducers 50 u 06391 SpO2 soft sensor adult M50E 07725 SpO2 soft sensor children M50B 031...

Страница 15: ...n Fleisch turbine or Lilly disposable 7 MIP MEP Connection 8 Pulse oximetry sensor connection 9 Power supply connection 10 USB connector for PC 11 USB connector for external printer 12 Ethernet Connec...

Страница 16: ...nect the external power supply to the socket no 9 located on the rear of the device and to the mains The power supply shoud be placed to allow an easy disconnection for any emergency situation The dis...

Страница 17: ...o the VC test Access to the MVV test Access to the Bronchoconstriction test Access to the Pulse oximetry test Access to the MIP MEP test Quality control procedure Calibration check Access to the Inter...

Страница 18: ...evice is turned off The charging time is about 20 hours DO NOT charge other type of batteries they could EXPLODE Remove old batteries to avoid they could spill its substances 2 4 3 POWER SAVING To sav...

Страница 19: ...inder into the printer on top of the paper with the cogwheel on the left hand side press until it clicks Pass the paper through the slot in the cover and close it A screen will appear to pull the pape...

Страница 20: ...le with the spirometer it will be already installed Otherwise you must remove the cover from the base of the spirometer and insert the bluetooth board where is shown in Figure The following steps must...

Страница 21: ...time the equipment and the PC are started The PC is then ready to receive the data transmitted by the equipment 2 4 8 INSTALLATION OF THE WEATHER STATION As in the previous case if you have purchased...

Страница 22: ...1 CUSTOMIZATION 2 MAINTENANCE 3 CALIBRATION 3 2 CUSTOMIZATION 3 2 1 INITIAL CUSTOMIZATION When the unit is turned on for the first time the following screen will appear Select the desired language to...

Страница 23: ...choose the operating mode among Occupational Medicine Primary Care or Diagnostic EASY OC AP DIAGNOSTIC OC AP DG The spirometer has been developed to make it user friendly Ease of use is assured throug...

Страница 24: ...us Load configuration restores the default customization Save configuration Allows you to save the current configuration as the default Internal Database customization Number of registers to be advanc...

Страница 25: ...s of the program CWHSP of the US National Institute for Occupational Safety and Health NIOSH Incentive for children and adults Time audit enable disable show the time when the spirometry maneuver was...

Страница 26: ...lity alerts to assure compliance with ATS ERS EX ET or NLHEP criteria QC Prompts Calibration check alerts Date of the last calibration Require a daily Calibration check Enable the use of the Spiromete...

Страница 27: ...N enabled checkbox If enabled a screen will appear requesting the PIN when the equipment is turned on ENTER PIN Pin 0000 Enter the PIN and you may access to the main menu screen If an erroneous PIN is...

Страница 28: ...e battery is removed Press from the main menu 3 4 MAINTENANCE PROGRAM The equipment has an internal diagnostic program to perform system checks and several adjustments DO NOT OPEN the instrument to ca...

Страница 29: ...ration and or maintenance alerts Adjust of screen brightness and Internal printer contrast Dealer s data Equipment configuration change from positive VC to negative VC or vice versa Adding a new trans...

Страница 30: ...ing of atmospheric conditions of temperature pressure and humidity This is the reason to carry out a calibration check every day to validate that the device is within calibration limits If a device fa...

Страница 31: ...6 12 L s To simplify the procedure the spirometer allows you to carry out a single maneuver at Mid flow level 2 5 l s 4 Press to cancel the maneuver or to accept it and go to the next range of flow 5...

Страница 32: ...5 The expiratory and inspiratory factors remain unchanged in this routine You can program the spirometer in the COMMON CUSTOMIZATION menu to require a daily calibration check before allowing access t...

Страница 33: ...tion factor printed on each lot 3 digits The Fleisch transducers are also Factory pre calibrated with a calibration factor engraved on the side of each transducer 4 digits If several sessions have bee...

Страница 34: ...OSPIR TOUCH User s Manual 34 511 B00 MU2 REV 1 09 From the results screen Press to delete a record and to delete the entire database Press to print the calibration report Use to select the record desi...

Страница 35: ...CAPACITY FVC TEST 1 Ensure that the transducer is plugged in the correct socket Insert the antibacterial filter and or the disposable mouthpiece into the transducer as in the figures Lilly disposable...

Страница 36: ...RACE can be changed from the following groups Caucasian Afro American and Hispanic Smoke yrs Number of years the patient has been smoking C d Cigarettes smoked per day Between 0 and 100 This helps to...

Страница 37: ...eve high quality results always use the nose clip Always use bacterial filters when you suspect of patient infection 4 Instruct the patient on the test performance his cooperation is essential for pro...

Страница 38: ...euver as ATS ERS criteria and then will display the resulting graph and the parameters The maneuver performance can be ended at any time by pressing which will appear on the bottom left hand of the sc...

Страница 39: ...l if FVC is more than 1 liter or more than 100 ml if FVC is less than or equal to one liter 4 1 2 DISPLAYING RESULTS AND OPTIONS At the end of the test The current predicted and best maneuver graphs a...

Страница 40: ...report Consult the sections from 4 1 4 to 4 1 9 By default the maneuver selected is the best M1 Press to change the Incentive chart a Temporal bar Progress bar in function of time in three colors red...

Страница 41: ...n filled in between both parameters If an appears after the REF test this means that the predicted values have been extrapolated The best FVC and FEV1 values not necessary from the same maneuver QC gr...

Страница 42: ...t maneuver or the 3 best maneuvers on the database according to the option selected in SETUP MENU Option not available in OC mode 4 1 5 VIEWING THE INTERPRETATION Press to view the interpretation Acco...

Страница 43: ...ay do the following A VC test on the same patient An MVV test on the same patient A Post bronchodilator test on the same patient Enter data for a new patient Print the general report of all tests on t...

Страница 44: ...s not been performed according to the ATS ERS criteria ET This indicates that expiration did not end satisfactorily because the variation of accumulated volume during the last second of the maneuver w...

Страница 45: ...ician in providing the good instructions to the patient to produce high quality spirometry tests At the end of a maneuver a message on the screen will inform you as to whether the maneuver was accepta...

Страница 46: ...d 1L s for PEF The maneuver differs significantly from the previous ones The patient must inhale more deeply and exhale even more air Good Test Session After 2 acceptable maneuvers with at least the b...

Страница 47: ...fter the administration of a bronchodilator drug For this the tests should have previously been completed in PRE bronchodilator mode and saved to the PRE database The procedure to carry out POST Bronc...

Страница 48: ...MU2 REV 1 09 5 Select the PRE test with which to be compared and press FVC selected by default 6 Using keys and the VC and MVV tests can be seen and saved in PRE mode The screen then shows the two gra...

Страница 49: ...us it may provide a single report of spirometric results before PRE and after POST application of a bronchodilator drug 4 4 SLOW VITAL CAPACITY VC TEST 1 Access the test by pressing from the main scre...

Страница 50: ...e main screen 2 Inhale and exhale completely without interruption for at least 12 seconds The axes are displayed in VOLUME TIME mode The maximum time allowed for the maneuver is 15 seconds The equipme...

Страница 51: ...in the equipment s internal Database 2 Install the W20s Spirometry Software as detailed in its User s manual 3 Load the data to the PC by pressing on the W20s Software The screen shows a list of the...

Страница 52: ...zation PRUEBAS CSV Contains the database tests GRAFXxx CSV Contains the graphs in Flow Time mode The files from the previous transfer are renamed with the extension OLD 4 If you want to view the infor...

Страница 53: ...e the last version of the program contact After sales Service This will send you some files to be stored in the same location and then follow these instructions 1 Switch on the device 2 Run the W20s S...

Страница 54: ...ment systems at other locations The equipment shows the information in comma delimited mode making it compatible with many different systems The information is available in the following files PRUEBAS...

Страница 55: ...n LCD VGA of 640x480 Battery pack Ni Mh Rechargeable 9 6V 2 5Ah Operating Conditions Temperature 5 to 40 C Humidity 85 without condensation Pressure 850 to 1060 hPa 638 a 795 mmmHg 1500 a 0 m aprox Re...

Страница 56: ...ation and information EN 1041 2008 EN ISO15223 1 2016 EN 980 2008 Waste disposal according to WEEE Directive 2012 19 UE Electronic Device 2011 65 EU Rohs Directive starting on July 22nd 2014 Spirometr...

Страница 57: ...EMPERATURE LIMITATION LIMITATION OF MOISTURE LIMITATION OF PRESSURE CONSULT THE INSTRUCTIONS FOR USE PRECAUTION WARNING IDENTIFIED RISK START UP STANDBY BF APPLIED PART NO PHISIOLOGICAL PULSE OXIMETRY...

Страница 58: ...l Forced Expiratory Volume in 0 5seconds FEV1 l Same in 1 second FEV3 l Same in 3 seconds FEV 5 FVC Ratio FEV1 FVC Ratio FEV3 FVC Ratio FEV1 VC Ratio PEF l s Peak Expiratory Flow PEFT s Peak Expirator...

Страница 59: ...ds FEV075 FVC Ratio Quality alerts to assure compliance with ATS ERS and NLHEP criteria Acoustic and graphic indication of the start and end of each maneuver Start FVC expiration Using the retrograde...

Страница 60: ...ORRIS EEUU 24 to 100 AUSTRIA AUSTRIA 6 to 90 1 GUTIERREZ XILE 5 to 100 1 CASTRO PEREIRA BRAZIL 6 to 76 1 POLGAR WENG 4 to 100 HANKINSON NHANES III EEUU 4 to 100 PEREZ PADILLA MEXICO 7 to 100 1 CRUZ MO...

Страница 61: ...or 300 ml s Volume Flow PEF Time related precision 0 50 Volume resolution 10ml 10ml 10ml Sampling frequency 100Hz 100Hz 100Hz Transducer lifetime 1400 disinfect or 3 years 1400 disinfect or 3 years O...

Страница 62: ...normal user of the equipment For your safety disconnect the equipment from electrical power or remove the battery before cleaning 7 1 1 CLEANING THE SPIROMETER The spirometer case can be cleaned with...

Страница 63: ...droplets leave them to dry at room temperature and re assemble the group again B TURBINE TRANSDUCER 1 Remove the turbine from its housing by pressing slightly its tab so that it comes away from its fi...

Страница 64: ...cts can affect the transducer s mesh inducing a loss of accuracy in the measurement D HANDLE AND TRANSDUCERS HOUSING Clean the external parts of the transducer s housing and handle with a wipe moisten...

Страница 65: ...U After Sales Service or your distributor to review or repair it Actions carried out by skilled technical personnel According to the different regulations particularly the 93 42 EEC Medical Device Dir...

Страница 66: ...epairing the equipment that has stopped working due to malfunctioning or misuse leaving it in a good state On detecting any fault with equipment which interferes with its normal use disconnect the equ...

Страница 67: ...s intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Emissions test Emissions test Emissions test RF Radi...

Страница 68: ...ains power quality should be that of a typical commercial or hospital environment The input output line cables are shorter than 3 meters long Surge EN IEC 61000 4 5 0 5 1 kV differential mode Line to...

Страница 69: ...est Electrostatic discharge ESD EN IEC 61000 4 2 8 kV contact 2 4 8 15 kV air 8 kV contact 2 4 8 15 kV air Radiated RF EN IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM at 1kHz 3 V m Proximity fields fro...

Страница 70: ...tion Power W Distance m E V m 385 380 390 Pulse 18Hz 1 8 0 3 27 450 430 470 FM D 5kHz 1kHz sinus 2 0 3 28 710 745 780 704 787 Pulse 217Hz 0 2 0 3 9 810 870 930 800 960 Pulse 18Hz 2 0 3 28 1720 1845 19...

Страница 71: ...processing the data of his patients according to the Law The observance of the recommendations included in this section does not guarantee in any case the complete adequacy of the user s activity to...

Страница 72: ...rmore in the event of users deciding to dispose of the printed documents their effective physical destruction must be ensured to avoid unauthorized access thereto DATA TRANSMISSION This spirometer can...

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