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DATOSPIR TOUCH

1. Sibelm ibelmed ed DATOSPIR TOUCH User s Manual Biocompatibility Biological evaluation of medical devices EN ISO 10993 1 2009 AC 2010 Usability EN 60601 1 6 2010 Usability EN 62366 2008 Spirometers for forced spiratory volumes measurement EN ISO 26782 2009 AC 2009 Spirometers for peak spiratory flow EN ISO 23747 2009 Software of medical devices EN 62304 2006 AC 2008 Pulsioximetry ISO 80601 1 2 61 2011 Vibration and temperature Series EN 60721 1995 and Series EN 60068 1999 Documentation and information EN 1041 2008 EN ISO 15223 1 2012 EN 980 2008 Waste disposal according to WEEE Directive 2002 96 CE Electronic Device 2011 65 EU Rohs Directive starting on July 22nd 2014 Spirometry standards ATS ERS Standards in force 1 Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 26 153 161 2 Miller MR Hankinson J Brusasco V et al Standardisation of spirometry Eur Respir J 2005 26 319 338 3 V Brusasco R Crapo and G Viegi Standardisation of the measurement of lung volumen Eur Respir J 2005 26 511 522 SEPAR Sanchis et al Normativa para la espirometria forzada Recomendaciones SEPAR num 1 Arch Bronconeumol 1989 25 132 142 NLHEP Ferguson et al Office Spirometry for Lung Health Assessment in Adults Chest 2000 117 1146 1161 511 BOO MU2 e REV 1 06 Sibelmed ed DATOSPIR TOUCH User s Manual
2. Interference may occur in the vicinity of equipment marked with the following symbol OI Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which DATOSPIR TOUCH is used exceeds the applicable RF compliance level above DATOSPIR TOUCH should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such reorienting or relocating DATOSPIR TOUCH P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Recommended separation distances between portable and mobile RF communications equipment and DATOSPIR TOUCH DATOSPIR TOUCH is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of DATOSPIR TOUCH can help prevent electromagnetic
3. 6 2 SYMBOLS SERIAL NUMBER E 2 MANUFACTURER Manufacturing date manufacturer s name and address LOT NUMBER p o PRODUCT REFERENCE EXPIRATION DATE DO NOT REUSE TEMPERATURE LIMITATION LIMITATION OF MOISTURE LIMITATION OF PRESSURE CONSULT THE INSTRUCTIONS FOR USE PRECAUTION START UP STANDBY BF APPLIED PART NO PHISIOLOGICAL PULSE OXIMETRY ALARMS BICEE QA SOK Fi IPX2 PROTECTED AGAINST DRIPPING WATER WHEN TILTED UP TO 15 5 zZ z WASTE DISPOSAL ACCORDING THE WAEE DIRECTIVE af SENSITIVE CONNECTOR TO ELECTROSTATIC DISCHARGES See Annex 1 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Lei ENTRANCE EXTERNAL POWER SUPPLY 6 3 TESTS FUNCTIONS AND PARAMETERS Available Information on tests e Percentage deviation in relation to predicted values e Standardized values of predicted that can be selected from several standards e Patiente ID details e Atmospheric data on temperature pressure and relative humidity e Availability of up to 8 maneuvers in the same study e Graphs in flow volume and volume time for FVC Bronchodilatation and Bronchoconstriction tests e Graphs in flow volume for VC and MVV tests FORCED VITAL CAPACITY FVC e FVC l Forced Vital Capacity e FEVO 5 l Forced Expiratory Volume in 0 5seconds e FEV1 l Same in 1 second e FEV3 l Same in 3 seconds e FEV 5 FVC Ratio e FEV1 FVC Ratio e FEV3 FVC Ratio
4. The patient s symptoms and capacity to perform a spirometry test must be taken into account by medical staff before any spirometric testing is undertaken Acceptability of a test is the responsibility of the medical professionals The spirometer should not be used when it is likely that the validity of the results could be compromised by external factors Take care NOT to place the equipment where it could be splashed by water or other liquids or cover it with objects that prevent air from circulating around it while it is running 511 BOO MU2 e REV 1 06 Sijbelmed TI DATOSPIR TOUCH User s Manual OAA The device should NOT be used stacked or adjacent to other equipment All accessories and spare parts must be originals and they must be requested from the manufacturer or authorized dealer in order to ensure the safety of the patient and the correct working order of the spirometer Failure to do so may result in an increase of emissions or in a decrease of the immunity of the equipment The equipment must be stored and used within the temperature pressure and humidity ranges specified in the section 6 1 WATER INGRESS PROTECTION LEVEL IPX2 Equipment Protected against falling water equivalent to 3 5mm rainfall per minute during 10 minutes Unit placed tilted 15 degrees in each direction from normal operating position In compliance with ISO 80601 2 61 2011 ELECTRICAL RISKS To avoid the risk of electric shock this e
5. In order to assess the pulmonary function of the patient it is necessary to obtain acceptable test quality The test quality depends on cooperation of the patient and this in turn depends on the quality of the technician s instructions Accordingly DATOSPIR TOUCH incorporates an automatic quality control function based on the recommendations of the National Lung Health Education Program NLHEP with prompts to assist the technician in providing the good instructions to the patient to produce high quality spirometry tests At the end ofa maneuver a message on the screen will inform you as to whether the maneuver was acceptable or not If not a prompt will guide you on how to coach the patient to do it better See the rows in white of the following table As soon as the message Good test Session appears do not carry out further maneuvers If even after repeated attempts it is not possible to obtain an adequate number of good maneuvers you 511 BOO MU2 e REV 1 06 Sibelmed BATOSPIRI should take a break depending on how the patient feels or stop measurement A Only one of the following QC prompts is displayed after a performed maneuver in the order of priority listed below QC Prompt Criteria How to improve the maneuver Don t Hesitate The patient must start exhaling Don t Hesitate Ex error Thepatientmuststartexhaling Blast Out Time to PEF higher than The patient must exhale as Faster 120ms hard firm
6. e FEV1 VC Ratio e PEF l s Peak Expiratory Flow e PEFT s Peak Expiratory Flow e FEF25 l s Forced Expiratory Flow 25 into the maneuver e FEF50 l s Same 50 into the maneuver e FEF75 l s Same 75 into the maneuver e FEF25 75 l s Mean expiratory flow between 25 and 75 of the FVC e FEF75 85 l s Mean flow between 75 85 of FVC e FET25 75 s Forced expiratory time between 25 75 of FVC e FET100 s Forced Expiratory Time e MEF50 MIF50 Ratio e FEV1 FEV 5 Ratio e FEV1 PEF Ratio e MIF50 l s Maximum Inspiratory flow with 50 of FVC inspired 511 BOO MU2 e REV 1 06 l Sibelmed DATOSPIR TOUCH User s Manual e FIVC l Forced Inspiratory Vital Capacity e FIV1 l Forced Inspiratory Volume in 1 second e FIV1 FIVC Ratio e FEV1 FIV1 Ratio e PIF l s Inspiratory Flow Apex e MTT s Mean Transit Time e PEF PIF Ratio e Vext Yo Extrapolated Volume e MVVInd l min Maximum Voluntary Ventilation 30 x FEV1 e FEV6 l Forced Expiratory Volume in 6seconds e FEV1 FEV6 Ratio e EPOC rate Parameter that depends on the number of cigarettes smoked a day the age and FEV1 Indicates the risk of EPOC e Lung Age Parameter that depends on the height and FEVI This indicates the equivalent age of the lung e Quality alerts to assure compliance with ATS ERS and NLHEP criteria e Acoustic and graphic indication of the start and end of each maneuver e Start FVC expiration U
7. 51 6 COMMUNICATIONS SYSTEM 0 52 6 1 TRANSFERRING TESTS TO THE PO 2 52 6 2 TRANSFERRING EQUIPMENT CHECK DATA eee SE 6 3 ADDING MODULE OPTIONS AND OR TRANSDUCER ooo aaa 54 6 4 UPDATING FIRMWARE E 33 6 5 EXPORTING TESTS TO OTHER SYSTEMS tisi ae 55 7 TECHNICAL SPECIFICATIONS cece 57 7 1 GENERAL SPECIFICATION nennen 57 Ze d ee 59 7 3 TESTS FUNCTIONS AND PARAMETERS use 60 2 PREDICTED SETS errr eee ence ments te R a 62 7 5 FVC INTERPRETATION DIAGNOSIS espontanea stes 62 220 TRAN DODUCER EE 63 Tae MANUFACTURER S LIABILITY a 63 8 CLEANING AND MAINTENANCE l 64 8 1 CLEANING DISINFECTION sen een 64 8 2 PREVENTIVE MAINTENANCE en ee 66 8 3 CORRECTIVE MATNTENANCE een en 67 Annex 1 ELECTROMAGNETIC COMPATIBILITY 63 Annex 2 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 467 EE 73 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual er The DATOSPIR TOUCH Spirometer has been designed by the R D I Department of SIBEL S A with the collaboration of the Pneumology Service of 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 Society and National Institutions SEPAR Spanish Pneumology and Thoracic Surgery Society 01 d COMPLIANT PRODUCT 93 42 EEC Medical Device Directive Class IIa Revised Approved Date 20
8. 6 kV contact 6 kV contact Floors should be wood concrete or ESD 8 kV air SONS dir ceramic tile If floors are covered with EN IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Yo Electrical fast 2 kV for power supply 2 kV for power Mains power quality should be that of a transient burst lines supply lines typical commercial or hospital EN IEC 61000 4 4 1 kV for input output environment k 1 kV for input output lines To Ethernet cable Surge 1 kV differential 1 kV differential Mains power quality should be that of a EN IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment Voltage dips short 5 Yo Ut gt 95 Yo dip in 5 Yo Ut gt 95 Yo dip Mains power quality should be that of a interruptions and Ut for 0 5 cycle in Ut for 0 5 cycle typical commercial or hospital voltage variations on o Y din i o Y din i environment If the user of the DATOSPIR power supply input ren 40 Ut Gu 2 pin TOUCH requires continued operation lines during power mains interruptions it is EN IEC 61000 4 11 70 Yo Ut 30 Yo dip in Ut 70 Ut 30 dp in recommended that the DATOSPIR for 25 cycles Ut for 25 cycles TOUCH be powered from an 95 Yo Ut gt 5 Yo dip in Ut 95 Ut 25 Yo dip uninterruptible power supply or a battery for 5 seconds in Ut for 5 seconds for 5 cycles Ut for 5 cycles Power frequency 50 60 Power frequency magnetic fields should Hz
9. DES Bronchodilation Post Bronchoconstriction LI Alternated V T amp F V plots Simultaneous V T amp F V plots I ooo Superposed curves Acoustic signal for begin and end of maneuver Time based progress bar adult incentive Volume based progress bar adult incentive Parameter and plot selection customization Calibration program Cal check Large graphs on reports Print save 3 maneuvers Print 3 PRE maneuvers data and graphs Time audit module Miller Interpretation Snider Kory amp Lyons NLHEP Ferguson Interpretation ATS ERS McKay Interpretation Quality of the FVC test NLHEP QC prompts QC grades Keess Ess Help screen in all menus Pediatric incentives Device auto check program Import external patient data Export data to Health Information Systems Included Optional Kees Not included A model can be upgraded at any time by adding the corresponding parts To do so please contact the SIBEL S A Sales Department or your dealer 511 BOO MU2 e REV 1 06 PS Sibelmed DATOSPIR TOUCH User s Manual 2 82217 2 2 3 ACCESSORIES Easy Diagnostic DIT FF DT E TRANSDUCERS TRANSDUCERS Jn 1 Disposable KE Er 2 Turbine KI LC w 3 Fleisch EI EA ACCESSORIES STANDARD Thermal paper 110x50 USB and printer cable connection Nose clip Plastic Mouthpiece Bi Es Disposable mouthpiece pack 25 u K RS Disposable transducers pack 25 u ka ES ENE 10 Exte
10. It will be necessary to perform 3 maneuvers at each flow level within the flow range O 12 L s To simplify the Calibration procedure the spirometer allows you to carry out at least 3 maneuvers at Mid flow level 2 5 I s To carry out the calibration procedure press La and then QI Enter the necessary data described below and follow the instructions detailed in the section 3 6 e Volume of the syringe 1 6L e No of Pulses of the Turbine transducer Each turbine is factory calibrated individually and is associated to a factor 3 digits equivalent to the pulses liter detected and printed on it e Transducer Factor the Lilly Disposable transducers are factory pre calibrated with an associated calibration 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 If several sessions have been performed only the correct last one will be saved Then you can print a report with the calibration record If calibration is performed to more than one level of flow the results on screen and on the report will be sorted from lowest to highest flow 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual QLIVENTT 3 7 CALIBRATION RECORD The spirometer has a record containing the information of the last 30 calibrations check and calibrations performed indicating date time volume accuracy percentage and average
11. MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 25 C 760mmHg 60 PATIENT DETAIL a 0 pr los 33 3 Name Surnames Age Ethnic F Smoke yrs ES Cig day ID Patient identifier 10 character alphanumeric Name 20 character alphanumeric field Surname 25 character alphanumeric field Age Number of years between 4 and 100 Weight Between 15 and 200 kg Between 33 and 440 Lb Height Between 50 and 230 cm Between 20 and 90 In Sex Male or female Race Ethnic Factor between 80 and 120 It is used in areas without their own predicted equations so data needs to be corrected to a specific percentage 100 is equivalent to the unmodified standard value of the predicted If the NHANESIII predicted set has been chosen in the Customization menu the 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 O and 100 This helps to calculate the COPD index parameter Technician 10 character alphanumerical technician s code or name Transducer Transducer s pre calibration factor Code 1 The disposable and Fleisch transducers are factory pre calibrated with an associated calibration code that have to be entered into the spirometer for a correct measurement a unique factor for each Fleisch transducer or for each lot of disposable transducers A The calibration factor may va
12. be stored in the same location and then follow these instructions 1 Switch on the device 2 Run the W20s Spirometry Software the W20s in demo mode provided upon purchasing the equipment is enough 3 Access the Configuration Links option Then check that the DATOSPIR TOUCH is selected Access the Configuration Hardware Test option Run a communications test to check that the connections are correct 4 Access the Configuration Utilities Update Flash option A dialogue box will be opened A Next step number 5 is only necessary to update from version 1 07 to a new version 5 Select in the computer system the file D150B tsk and press Send selecting previously TSK type files The new file will transmitted in one minute depending on the computer Switch off and on the device 6 Select now in the computer the file Load prj and press again the button Send The new program will be transmitted The process may take around 10 minutes depending on the PC 7 Switch off the DATOSPIR TOUCH 8 Once loaded the program turn on the spirometer holding pressed the ON OFF button for 5 seconds 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 5 5 EXPORTING TESTS TO OTHER SYSTEMS The DATOSPIR TOUCH spirometer can export the tests saved previously in the Internal Database to other management systems at other locations The equipment shows the information in comma delimited mode making it compati
13. e Easy for occupational and primary care e Diagnostic for lung function laboratories occupational and primary care also included Di T F D TF Disposable AER BT Turbine EI Fall Fleisch ES ES SETTINGS Occupational Medicine Mode Primary care Mode Diagnostic mode 1 000 test internal database with graphics 3 000 test internal database with graphics Bronchoconstriction module W20s Spirometry software CONNECTIVITY USB to extern printer connection USB to PC Ethernet module Bluetooth module Included RS Optional KES Not included 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 2 2 2 OPERATING MODES There are 3 operating modes available Choose the settings that best fit your needs e Diagnostic Mode DG Orientated to Lung Function Laboratories This is the most complete mode Practically all the functionalities of the device are available and it allows you to use whatever operating mode e Primary care Mode PC Orientated to Primary Care It includes quality alerts to assist you in producing high quality spirometry tests Direct access to FVC Bronchodilatation VC and MVV tests e Occupational Medicine Mode OC Orientated to Prevention Centers and Mutual Ideal for screening it is easy to use and allows you to perform FVC and Bronchodilatation tests 511 BOO MU2 e REV 1 06 Sibe med DATOSPIR TOUCH User s Manual AE li foc pc DIAG FVC VC MW
14. 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 252c 760mmHg 60 fin 1 D PWC FEMI PRED 4 37 3 81 2 E E E E EE l 1 1 I I nan N N Fi an LI y ISS E G00C8 834 At the end of the test e The current predicted and best maneuver graphs are shown e On the summary frame the FVC and FEV values of all the maneuvers performed will appear PRED indicates the patient s Predicted value indicates the current maneuver Mx indicates the selected maneuver 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Maneuvers are sorted from best M1 to worst M8 according to ATS ERS criteria and are shown in different colors green for those that are acceptable and repetitive and from yellow to red the lower quality maneuvers In white the current maneuver a e Press to enlarge or reduce the graph e Press on the plot to switch from one graphic type to the other Flow Volume Volume Time both or incentive and a Small Flow Volume graph u E e Selection of the desired maneuver Mx the scroll allows you to move over the maneuvers performed and select the desired one to see the graph view the parameters consult the diagnosis delete or save a maneuver or print out a report Consult the sections from 4 1 4 to 4 1 9 AN ay default the maneuver selected is the best Mi e Press to change
15. the Incentive chart a Temporal bar Progress bar in function of time in three colors red indicating less than 4 seconds orange between A and 6 seconds and green for more than 6 seconds b Volume bar Progress bar in terms of the expired volume Red indicates 75 below the predicted value the orange between 75 and 100 and green 100 above the predicted value c Incentives for children 511 BOO MU2 e REV 1 06 Sibe med DATOSPIR TOUCH User s Manual A E e Time audit show the exact time of testing have been carried out in the reports for a further monitoring e Press on ID area to access the patient s data Screen e Press the to display all parameters data of maneuvers performed 252c 760mmHg 60 TEST DATA a li S fe 2 08 36 08 36 1 50 4 93 0 70 e Observed values of the parameters selected in the CUSTOMIZATION MENU e Predicted values REF If patient s data has been filled in e between both parameters If an appears after the REF test this means that the predicted values have been extrapolated e The best FVC and FEV1 values not necessary from the Same maneuver e QC grade e ATS ERS alerts e Time audit 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual A The screen only displays the results of 3 maneuvers and the predicted By default it appears the data of the 3 best maneuvers m m and m To view the data of the other maneuvers perf
16. 14 06 Date 2014 06 Technical Director Sales Director 511 BOO MU2 e REV 1 06 Sibelmed TI DATOSPIR TOUCH User s Manual A 1 SAFETY SPECIAL PRECAUTIONS The DATOSPIR TOUCH spirometer has been designed for use with the safety in mind All operating instructions must be read before using it Failure to do so could cause injury to the user or patient and damage to the equipment and or accessories INTENDED USE a Measurement of lung flows and volumes for the diagnostic and control of respiratory diseases Asthma COPD etc b Measurement of peripheral blood oxygen saturation and cardiac pulse for the respiratory diagnostic c Measurement of inspiratory and expiratory maxima pressures for the respiratory 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 be used under high ambient noise levels to ensure that the patient may hear the acoustic signal of the device The equipment should be placed in a safe position to avoid falling that may result in equipment damage or harm to the patient and or user The spirometer is NOT designed for use under other conditions or using other power sources not indicated in this manual Use only accessories specified in this manual The spirometer is intended to be used in the following patient population a Age more than 4 years unti
17. 2 seconds e The axes are displayed in VOLUME TIME mode The maximum time allowed for the maneuver is 15 seconds e The equipment saves a maximum of 8 maneuvers ordered according to the MVV value where M1 is the best MVV and M8 the worst 25 C 760mmHg 60 1D 1 mw WR Q pr 08 53 OM BE MIN 1 I min PRED 129 47 N 500 Mi 150 82 44 12 450 ki 400 350 300 250 200 150 100 50 0 3 6 9 12 15 vi a E N w a n 511 BOO MU2 e REV 1 06 belmed DATOSPIR TOUCH User s Manual SI 5 COMMUNICATIONS SYSTEM One of the strengths of the DATOSPIR TOUCH spirometer is its Communications System which allows the user to 1 Transfer patient tests to a PC 2 Transfer Equipment Checking Data 3 Update Internal Software 4 Export patient tests to other Management Systems Communications can be made via USB standard Bluetooth optional or Ethernet optional 5 1 TRANSFERRING TESTS TO THE PC If you want to view print manage and or save the tests to the PC you must have W20s Spirometry Software The process to follow is 1 Save the tests required 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 a on the W20s Software The screen shows a list of the tests transferred and you can select those to be imported to the PC Database selected in the W20s Software SETUP opt
18. DATOSPIR TOUCH SPIROMETER USER S MANUAL 511 BOO MU2 e REV 1 06 e 2014 06 Sibelmed Sibelmed DATOSPIR TOUCH User s Manual Sibelisss SIBEL S A Rossell6 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 Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com SIBEL S A belongs to SIBELGROUP 511 BOO MU2 e REV 1 06 Sibelmed ed DATOSPIR TOUCH User s Manual AAPP e ae 5 2 INSTRUCTIONS FOR USE 8 INSTALLATION 10 2L INTRODUC TION A ou ene ee 10 2 2 MODELS AND OPERATING MODES Abee ed AE 10 2 3 LAYOUT OF CONTROLS AND CONNECTORS u 17 2 4 INSTALLATION AND START UP anne 18 3 SPIROMETER CONFIGURATION gt 23 Sale EFOR EE 23 A I ZA TION WE 23 3 3 INTERNAL BPATABA SE een ee 29 3 4 MAINTENANCE PROGRAM unse ee 30 3 3 QUALITY CONTROL CALIBRATION CHECK essees 31 3 6 CALIBRATION ROCEDURE u 34 4 CALIBRATION RECORD tet ttaaatttaaatataaaesanaossanasssanossesnosstasosesononon 35 5 SPIROMETRIC TESTS PROCEDURES 36 5 1 FORCED VITAL CAPACITY FVC TEST eerren 36 EN I LITT OF FYC TESTS eto ene ere eer 45 5 3 POS BRONCHODILATION TEST cts 48 5 4 SLOW VITAL CAPACITY VE TEST een 50 5 5 MAXIMUM VOLUNTARY VENTILATION MVV TEST
19. G Clean the external parts of the transducer s housing and handle with a wipe moistened with soapy neutral water or with 960 alcohol Then they can be wiped dry Pay attention to avoid inserting strange elements into the pressure inlets of the Lilly handle clean it with the handle in inverted position Do not use abrasive substances or solvents 7 1 3 CLEANING THE SPIROMETER The spirometer case can be cleaned with a wipe moistened with soapy neutral water or with 96 alcohol Then they can be wiped dry Take particular care to ensure that no liquid enters the interior of the device or the connectors and connections Do not use abrasive substances or solvents 7 2 PREVENTIVE MAINTENANCE Preventive maintenance consists of any actions aimed at keeping the equipment in a good working order Actions which can be carried out by the same user 1 Each time the spirometer is turned on the equipment will check certain parts and or functions In addition the user can access the Maintenance Program to adjust and or check any parts of the equipment as indicated in detail in the corresponding section 2 A second procedure which can be performed by the user consists of regular monitoring of the appearance of the different connections and other external parts of the 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual equipment Check that all connections are perfectly connected that no cable and or connector or
20. IZATION MENU I ATS ERS ALERTS To ensure good spirometry the technician will pay particular attention to ensure that the patient has made the utmost effort that the start has been good and that no coughing or Valsava s maneuver due to glottis closure has occurred Special attention must be paid to preventing expiration from ending too soon Once the maneuver is finished one or two Alerts may appear on the screen indicating that the maneuver has 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 was over 25 ml or that the maneuver lasted for less than 6 seconds in individuals 10 or older or less than 3 seconds in children under 10 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual EX This indicates that the expiration did not start satisfactorily because the extrapolated volume was greater than 5 of the FVC or 0 15 liters According to the ATS ERS recommendations this volume should be lower than 5 of the FVC or 0 15 liters whichever is greater A The technician performing the spirometry may disable these alerts in the CUSTOMIZATION MENU In this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when classifying the order of the maneuvers II NLHEP ALERTS QC PROMPTS
21. MEP module to measure Maximal Inspiratory and Expiratory Pressures an electronic Pulse oximetry module exclusively for taking Oxygen Saturation and Pulse Rate samples SpO gt and an Ethernet 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 device to permanent records print hard copies of selected data or transfer test to telemedicine platforms or clinical information systems Thus it allows carrying out interactive real time testing on your PC and transfer status device data 2 2 MODELS AND OPERATING MODES 2 2 1 MODELS The DATOSPIR TOUCH series is available in 6 different models e DATOSPIR TOUCH EASY T e DATOSPIR TOUCH DIAGNOSTIC T e DATOSPIR TOUCH EASY F e DATOSPIR TOUCH DIAGNOSTIC F e DATOSPIR TOUCH EASY D e DATOSPIR TOUCH DIAGNOSTIC D This manual is intended for all models and options of the DATOSPIR TOUCH spirometer Therefore only specific options and functions of the model available will be applicable in each case 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual AA ba The following table shows the standard features and optional functions for each model The spirometer has three possible different transducers e Turbine Transducer e Fleisch Transducer e Disposable Transducer Lilly type And two software configuration choices
22. O MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 2 4 4 PLACEMENT OF THE PAPER INTO THE INTERNAL PRINTER Open the printer cover lift the lever that unlocks the pull cylinder and insert the paper roll Pull a small amount of paper out put down the header lever pass the paper through the slot of the cover and close it A screen will appear to pull the paper in out Cut the paper pulling it forwards 2 4 5 CONNECTION TO AN EXTERNAL PRINTER Select the external printer option in the COMMON CUSTOMIZATION menu Connect the USB cable into the socket n 11 PRINT and the other end to the printer Contact the manufacturer or dealer for a list of compatible printers 2 4 6 USB CONNECTION TO PC To connect the device to a PC install the USB driver and the W20s Spirometry Software in the PC Consult the W20s Spirometry Software User s Manual Then connect the correct end of the USB cable to the socket n 10 and the other end to the computer I LI Cc ro e EDAMA 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 2 4 7 BLUETOOTH CONNECTION TO PC If you have purchased this module with the spirometer it will be already installed Otherwise you must remove the cover from the s base of the spirometer and insert the bluetooth board where is shown in Figure Then in both cases connect the Bluetooth adapter to the PC and simply install the software included To do so consult
23. PIN code user configurable that seeks to prevent access by unauthorized people to the equipment and more specifically to the private data it contains To comply with current legislation users must enable this option and configure their PIN They will be held responsible for providing this PIN to the authorized people Thus when the spirometer is started the PIN will be requested and the equipment locked where this PIN is entered erroneously three times On restarting the equipment the unlock code PUK provided by the manufacturer upon purchasing the equipment will be requested If this code is not available the equipment will remain locked e PRINTING DOCUMENTS In the event of saving paper printouts containing patient details these documents must be properly stored so that only duly authorized personnel have access to them Furthermore in the event of users deciding to dispose of the printed documents their effective physical destruction must be ensured to avoid unauthorized access thereto e DATA TRANSMISSION This spirometer can transmit files containing patient details via PC connection so that work can be Subsequently carried out on them using the W20s Spirometry Software This software is also compliant with the Data Protection Act as explained in its User s Manual 511 BOO MU2 e REV 1 06
24. The patient breathes normally and when indicated by the technician takes a deep breath completely filling his lungs and then performs a FORCED EXPIRATION followed by FORCED INSPIRATION if desired 6 The device will detect the end of maneuver 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 G which will appear on the bottom left hand of the screen 25 C 6Dmahy BOX Y 23339323083 At the end of the maneuver one or more of the QC Alerts if the option is enabled in the Customization menu may appear alerting the technician as to whether the maneuver is in compliance with ATS ERS or NLHEP Quality Control criteria Consult the section 4 2 A ATS ERS Criteria The maneuver with least warnings is considered the best ET EX With the same number of ATS ERS warnings ET EX the maneuver with the highest 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual sum of FVC FEV1 is considered the best 7 Perform at least 3 maneuvers but no more than 8 as this would tire the patient If 3 or more maneuvers have been performed and the FVC and or FEV parameters blink on and off this indicates that the repeatability criteria has been fulfilled for one or both parameters according to the ATS ERS criteria This criteria indicates that the two best FVC or FEV values do not differ by more than 150 ml if FVC
25. V 1 06 Sibelmed DATOSPIR TOUCH User s Manual 3 2 2 TOOLBAR CUSTOMIZATION 25 C 760mmHg 60 DI AGNOSTIC MODE 25 C 760mmHg 60 gt a 60 It displays the values of atmospheric parameters Temperature Pressure and Humidity The temperature is automatically obtained from an internal sensor incorporated to the spirometer and its value will always appear in the tools bar If you acquire the weather station module besides temperature will be shown the real values of pressure and humidity Otherwise touch this label to enter them manually DIAGNOSTIC MODE Touch on this label to choose the operating mode among Occupational Medicine Primary Care or Diagnostic EASY OC AP DIAGNOSTIC OC AP DG m The spirometer has been developed to make it The DATOSPIR TOUCH sel roneter incas at e user friendly Ease of use is assured through context sensitive help screens that explain t clarifies the manise of the various icons Icons avaliable an the min EE every DATOSPIR TOUCH feature by touching Pul spox l ma try this icon 4 Touch this icon to adjust brightness 17 37 S Clock calendar Touch the displayed time to adjust time and date Power supply cord detection Battery status It displays the levels of battery charge by the segmented battery icon When this icon turns red the battery is nearly discharged and it must be recharged See the battery s chargin
26. accessories transducers cables and spare parts 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 decrease the immunity of the equipment DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION Never dispose of the DATOSPIR TOUCH its accessories and its batteries in the household trash It must be disposed of properly and may need to be recycled in accordance with the statutory requirements in your country Devices commercialized before July 22nd 2014 The device contains lead for the electric soldering It uses a lithium battery and could use an optional NiMh battery Information on proper disposal is available from your dealer or from Technical Support at SIBEL S A 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual A E Lalla 2 INSTRUCTIONS FOR USE AND INSTALLATION 2 1 INTRODUCTION The DATOSPIR TOUCH spirometer is a compact device based on different types of transducers Fleisch Turbine or Lilly disposable a wide high resolution color touch screen and an internal thermal printer Has an internal database to store the performed tests and also allows connection to an external printer via USB or Bluetooth In addition it may incorporate a Weather Station to measure pressure and humidity it includes a temperature sensor a MIP
27. and fast as possible The patient has abruptly Blow Out interrupted exhalation The Longer ET error patient must exhale even more and expel as much air as possible from his her lungs The maneuver differs significantly from the previous ones The patient can exhale even more vigorously and achieve a higher peak flow If there are not 2 acceptable The maneuver differs maneuvers with at least the significantly from the previous Deeper Breath largest 2 FVC values matching ones The patient must inhale within 150mL and 1L s for more deeply and exhale even PEF more air Good Test After 2 acceptable maneuvers TEST COMPLETE Adequate kk ke e number of good maneuvers Referring to the quality of the last maneuver performed Referring to the reproducibility of the maneuvers performed If there are not 2 acceptable Blast Out maneuvers with at least the Harder largest 2 PEF values matching within 1 L s III NLHEP QUALITY GRADING QC GRADES At the end of the test maneuvers session a quality grading from A to F will be displayed to indicate the reliability of the results according to NLHEP criteria A B and C grades indicate a reliable result but a grade D or F indicates a poor quality test in this case the results should be interpreted with caution 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual GRADE TEST CRITERIA At least 2 acceptable maneuvers with the VERY GOOD largest 2 FEV values
28. any other element is broken or damaged 3 Execute a calibration check with a 3 L syringe Calibration checks must be undertaken daily 4 Define the periods in days between calibrations or preventive maintenance work on the CUSTOMIZATION MENU of the equipment If the days specified are exceeded the equipment warns of such by displaying a sign every time it is started If O days is entered a warning is never given In the event of detecting any problem that the user cannot solve contact the SIBEL S A 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 Directive electromedical devices should be verified and or calibrated regularly to ensure reliable functions and the safety of patients users and the environment This Technical check will be performed every year following the DATOSPIR TOUCH Verification and Adjustment Procedures available from the manufacturer SIBEL S A This type of operation must be carried out by skilled technical staff from the distributor s or manufacturer s technical service On all accounts SIBEL S A as the manufacturer must provide written authorization for at least the guarantee period for the corresponding technical personnel to carry out said maintenance and will not be held liable under any circumstances for any damage malfunction etc that may
29. arise as a result of defective maintenance by people not employed by SIBEL S A 7 3 CORRECTIVE MAINTENANCE Corrective maintenance consists of repairing the equipment that 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 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 equipment from the mains and contact SIBEL S A After Sales Service Specify the problem in as much detail as possible 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual LALA TARA Annex 1 ELECTROMAGNETIC COMPATIBILITY 1 1 ELECTROSTATIC DISCHARGE The Datospir Touch uses the exception of electrostatic discharge test on the Ethernet connector as described in EN60601 1 2 2007 For this reason as stated in paragraph 5 1 2 of the standard the A symbol Ate must be placed next to the Ethernet connector This symbol does not imply any problem of safety to the technician or to the patient Neither implies that the Ethernet module is damaged It would only cause that the Ethernet communication stops running for a moment However to avoid any slightest problem you should take the following precautions Connect and disconnect the Ethernet cable when the device is turned off During the functioning of the equipment do not touch the connector with your fingers Inform to all staff involved
30. ble with many different systems The information is available in the following files PRUEBAS CSV Contains the database tests PATIENTS CSV Contains the database patients GRAFxx CSV Contains the graphs in Flow Time mode The graph file as indicated contains the graphs for each test in Flow Time mode If you want to display the graphs in Volume Time or Flow Volume mode in the new management system the following aspects must be taken into account e The Flow signal is sampled at 100Hz e The ratio of the axes in the Volume Time graph must be e adjusted to 1 liter 2 seconds e The ratio of the axes in the Flow Volume graph must be adjusted to 2 l s 1 l In the event of doubt or queries contact the SIBEL S A Technical Support or your distributor who will provide any further information you may require 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 6 TECHNICAL SPECIFICATIONS 6 1 GENERAL SPECIFICATIONS Power supply Input 100 to 240V 50 to 60Hz Output 12V 2 5 A Electrical Protection Class 1 Compatible external e MEANWELL MES30A 3P1J power supplies e EMERSON DP4012N3M e DANUBE FRMO30 S124 Medical device Class Ila classification Protection level IPX2 Device not power supply is protected against vertically dripping water when the enclosure is tilted up to 15 degrees and Weight 1 7 kg with battery approx Storage capacity e 2 types of database according to their storage capacity Da
31. e med DATOSPIR TOUCH User s Manual A Elia 06611 03052 07147 05602 01149 06186 08187 Ethernet cable MIP MEP Shutter probe Sniff probe for MIP MEP module MIP MEP mouthpiece Paediatric Mouthpiece adapter Fleisch Transducer Fleisch filter 3u Included MM Optional 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual AA it 2 3 LAYOUT OF CONTROLS AND CONNECTORS FRONT PANNEL REAR PANNEL BASE f ben 1 Internal printer thermal paper roll 2 Lever to lock unlock the paper roll 3 ON OFF button 4 Color graphic touch screen 640 x480 pixels 5 Printer casing 6 Transducer Connection Fleisch turbine or Lilly disposable 7 MIP MEP Connection 8 Pulse oximetry sensor connection A Do not connect accessories not supplied by SIBEL S A 9 Power supply connection 10 USB connector for PC 11 USB connector for external printer 12 Ethernet Connection 13 Rechargeable battery location 14 Pulse oximetry board connection 15 Electronic Weather Station board connection 16 Bluetooth board connection 17 Lithium battery CR1815 18 Specifications plate 511 BOO MU2 e REV 1 06 Sibelmed TI DATOSPIR TOUCH User s Manual A 2 4 INSTALLATION AND START UP This spirometer has been manufactured using solid state professional components under strict quality controls However accidents may occur during the transportation or storage of the equipment and it is
32. ers If you do not want graphs certain parameters the diagnosis and or ATS ERS warnings to appear disable them on the CUSTOMIZATION MENU A Moreover by pressing in the Main menu you may print The last test performed All the tests carried out during the day MEN Whatever test you want of the database 4 1 7 OTHER TESTS ON THE SAME PATIENT After carrying out the FVC test on a patient you may do the following e A VC test on the same patient e An MVV test on the same patient s A Post bronchodilator test on the same patient e Enter data for a new patient e Print the general report of all tests on the same patient A The spirometer saves the best maneuver of each FVC VC MVV and or bronchodilator test to print a general report 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 4 1 8 CHANGING PATIENT DATA ENTER A NEW PATIENT EN This option allows you to enter a new patient data or to kg modify existing patient data Follow the procedure described in the section ENTERING PATIENT PARAMETERS You may access to this menu by pressing on the ID area from the tool bar in any test A If you have modified existing patient data age height sex etc the predicted parameters will be calculated again A 4 2 QUALITY OF FVC TEST The DATOSPIR TOUCH spirometer includes quality alerts to assist you in producing high quality spirometry tests These alerts may be enabled or disabled in the CUSTOM
33. est Quality control procedure Calibration check Access to the Internal database Database customization Printing a report Access to the Setup options Calibration Customization and Maintenance 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Pressing on the black area of the screen you may enable disable the main menu buttons 2 4 2 RECHARGEABLE BATTERY INSTALLATION AND LOAD The DATOSPIR TOUCH spirometer operates optionally with rechargeable Ni Mh battery 9 6V 2500mAh with an autonomy of 1 5 hours approx Connect To install the battery remove the base cover and insert it where indicated in the figure The battery is recharged by connecting the spirometer to the power supply even though the device is turned off The charging time is about 20 hours A 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 save power when working with battery the device includes an auto switch off system that turns the equipment off when the screen is not accessed for one minute except in tests screens In this case you will be prompted to save the data before powering off When the spirometer is connected to the power supply the backlight turns off after not accessing the screen for two minutes The device will sleep until one key is pressed recovering the information previously displayed 511 BO
34. flow for inspiratory and expiratory factors This is extremely useful for centers requiring a quality control of the processes they use and also to help define day to day laboratory variability From the results screen ET 760mmHg 60 CALIBRATION REGISTER an e Sei L J H 18 13 01 10 10 09 14 Cal 3 00 0 96 0 97 a CID Press E to delete a record and to delete the entire database Press lad to print the calibration report Use to select the record desired 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual AL 4 SPIROMETRIC TESTS PROCEDURES The procedures to be completed to carry out the Forced Vital Capacity FVC slow Vital Capacity VC and Maximum Voluntary Ventilation MVV tests are very similar Therefore only one detailed description will be given in this section 4 1 FORCED VITAL 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 aze Fleisch a 0 disposable si and 7 turbine A 7 if Wwe 2 Turn on the spirometer and press on the Main Screen Ar first time per day you carry out a spirometric test the spirometer may advise you to check the calibration as TAS ERS recommends Enable this option on the SETUP MENU 4 1 1 ENTERING PATIENT DATA Then the following screens will appear 511 BOO
35. g procedure in section 2 4 2 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Touch this icon to enter directly to the SETUP MENU 3 2 3 COMMON CUSTOMIZATION If you wish to change any logging parameter do so under this menu Access this option by pressing Lal from the main screen and then The options included in the CUSTOMIZATION MENU are Default Configuration This option memorizes a user defined customization program status A Load configuration restores the default customization OG Save configuration Allows you to save the current configuration as the default LR Internal Database customization e Number of registers to be advanced if performing a fast advance using the database search engine e Save 3 maneuvers from the FVC test e Sort database Common customization Language Enter a report header Select the printer type internal or external 2 Set clock calendar time and date 511 BOO MU2 e REV 1 06 helmed DATOSPIR TOUCH User s Manual Bibeli wc ER Set units cm Kg in lb C F or mmHg hPa Main menu icons enable disable A Equipment Protection code PIN Bluetooth enable disable Ethernet enable disable san Initial customization main menu icons spirometry parameters units predicted interpretation incentive chart pin printer configuration and report header Spirometry customization el Mi a f Select the Operating m
36. interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and DATOSPIR TOUCH as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter Maximum output power of transmitter De 150 kHz a 80 MHz De 80 MHz a 800 MHz 800 MHz to 2 5 GHz d kaki d GHP m 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 800 MHz the separation distance for the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absortion and reflection from structures objects and people 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Annex 2 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC REQUIREMENTS AFFECTING THE USER OF THE EQUIPMENT According to current legislation the user of this equipment is the only party responsible for saving and processing the details of his patients according to the Law CONFIGURATION OF DATOSPIR TOUCH PROTECTION The DATOSPIR TOUCH spirometer has an equipment protection option that uses a
37. ion For USB compatible spirometers a driver must be installed on the PC 4 Then you can select view or print any of the tests imported or transferred to the PC 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 5 2 TRANSFERRING EQUIPMENT CHECK DATA The DATOSPIR TOUCH includes a program that auto checks the working order of certain parts of the equipment displaying the information on the screen and saving it in an internal file e Hardware checkup e Firmware checkup e Equipment customization e Calibration Record e FVC test with standard curves 1 Start up the spirometer press La from the main menu and select MANITENANCE Access the Equipment Check option and run all the sub options following the instructions on the screen 2 Connect the equipment and the PC via USB or Bluetooth 3 Run the previously installed W20s Spirometry Software making sure that DATOSPIR TOUCH is selected in Configuration Links and access the Configuration Utilities Download Data option The transferred information is saved in the DATA directory of the application in the files STATUS CSV Contains the errors detected CALIBRA CSV Contains the calibration data CONFIG CSV Contains the equipment customization 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 information of an
38. ionship between the pressure drop and the airflow depends on the gas viscosity This viscosity is also depending 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 fails its calibration check then new calibration procedure or equipment maintenance is required to ensure the proper use of the Spirometer To verify that transducer operates properly the spirometer includes a simple check up procedure based on measuring the known volume of a calibration syringe Test procedure 1 Connect the spirometer to the 3 or 6L syringe as in the following figure inserting a tube one meter long to avoid the influence of the turbulence caused by the abrupt departure of the air DISPOSABLE SYRINGE HOSE TRANSDUCER 511 BOO MU2 e REV 1 06 Sibelned DATOSPIR TOUCH User s Manual CALIBRATION ADAPTER CALIBRATION SYRINGE 1 Power up the DATOSPIR TOUCH and press Q from the main menu 2 Discharge the syringe once at any range of the following flows varying between 0 12L s Low flow level 0 4 1 2 L s Mid flow level 2 5 L s High flow level 6 12 L s 25 C 760mmHg 60 l QUALITY CONTROL a Gad A To simplify the procedure the spirometer allows you to carry out a single maneuver at Mid flow level 2 5 1 s 3 Press Se to cancel the maneuver or a to accept it and go to the next ra
39. l elderly b Weight gt 15 Kg c Height gt 50 cm d Health status physical and mental condition that allows the performance of the forced maneuver 511 BOO MU2 e REV 1 06 Sibelmed TI DATOSPIR TOUCH User s Manual MAA USER PROFILE The spirometer is intended to be used by or under the direction of a medical professional Specific training on the Spirometry technique is recommended Bronchoconstriction test must be supervised by a qualified technician in the art Before using the spirometer on patients you should be familiar with the operation of equipment All information necessary for its operation is available in this Manual For additional training on the technique or on the product contact SIBEL S A or your dealer EFFECTS ON PATIENTS USING THE SPIROMETER The spirometry tests require patient cooperation Complete forced expiration is required 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 and the disabled LIMITATIONS FOR USE CONTRAINDICATIONS An analysis of the results of spirometry tests is not enough to give a correct diagnosis of the patient s clinical condition The patient s records and any tests that the clinician believes necessary must therefore also be considered A doctor must interpret all data to determine the course of treatment required
40. magnetic field be at levels characteristic of a typical EN IEC 61000 4 8 location in a typical commercial of hospital environment NOTE Ut is the a c mains voltage prior to application of the test level 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR TOUCH is intended for use in the electromagnetic environment specified below The costumer or the user of DATOSPIR TOUCH should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of DATOSPIR TOUCH including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 5 80 MHz to 800 MHz EN IEC 61000 150KHz to 80 MHz d E JP 4 6 Radiated RF 3 V m a 80 MHz to 800 MHz EN IEC 61000 80 MHz to 2 5 GHz d E JD 4 3 d Ak 800 MHz to 2 5 GHZ E where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
41. matching within 100mL and the largest 2 FEV values matching better than 100mL GOOD At least 2 acceptable maneuvers with FEV values matching between 101 and 150mL ACCEPTABLE At least 2 acceptable maneuvers with FEV values matching between 151 and 200 mL Only one acceptable maneuver or more than POOR one but the FEV values match gt 200 ml with no interpretation NOT ACCEPTABLE No acceptable maneuvers with no interpretation 4 3 POST BRONCHODILATION TEST The DATOSPIR TOUCH spirometer allows spirometry tests FVC VC or MVV after 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 Bronchodilator spirometry is 1 Complete an FVC VC or MVV test to the patient as described in the 4 1 section before administration of the bronchodilating drug 2 Save the PRE test in the database KE for comparison to the POST Drug test 3 Administer the dose of the bronchodilator drug prescribed and wait for the standardized period 4 On the main screen press amp A screen similar to the following will appear which displays the tests saved in PRE mode 511 BOO MU2 e REV 1 06 25 C 760mmHg 60 l PRE BRONCHIAL TESTS 5 Select the PRE test with which to be compared and FVC selected by default 6 Using keys and the VC and MVV tests can be seen and saved in PRE mode The
42. mization See the Pulse oximetry user s manual MIP MEP customization See the MIP MEP user s manual Press a to validate the values entered and to pass to the following screen to cancel and to escapes the actual screen and to move back to the previous one 511 BOO MU2 e REV 1 06 Sibelmed TI DATOSPIR TOUCH User s Manual 3 2 4 EQUIPMENT PROTECTION a In compliance with the data protection Act Directive 95 46 EC the DATOSPIR TOUCH has a protection option accessed by a PIN of 4 digits to prevent access to the equipment and more specifically to the private data it contains by unauthorized people Enable this option in the CUSTOMIZATION MENU consult section 3 2 3 by ticking the PIN Enabled checkbox and enter the PIN in the New Pin boxes To change the PIN you must enter the current one in the Current Pin box and then the new one in the New Pin boxes The PIN can be disabled again by entering the current PIN and unticking the PIN 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 entered three times the equipment will lock and switch off On restarting it a screen will appear requesting the unlock code or PUK supplied upon purchasing the equipment UNLOCK CODE PUK 000000000000000 If the correct code is entered the device
43. nge of flow 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual ee 4 At the end of the operation press fox to see the results of the maneuvers performed the percentages of variation and calibration factors calculated as the average of all the maneuvers performed on a range flow 252c 760mmHg 60 QUALITY CONTROL REPORT gy e Ca f18 02 5 If the session is correct the results will be automatically saved to the calibration record Press 6 to see the data of the record See section 3 7 6 Once calibration check performed satisfactorily access the Spirometry program to begin the tests 7 If the calibration check is not correct do a full calibration of the instrument To do so see 3 6 CALIBRATION PROCEDURE A The error at each flow should be less than 3 5 The expiratory and inspiratory factors remain unchanged in this routine A You can program the spirometer in the COMMON CUSTOMIZATION menu to require a daily calibration check before allowing access to any test By default this option is disabled 511 BOO MU2 e REV 1 06 Sibelmed TI DATOSPIR TOUCH User s Manual 3 6 CALIBRATION PROCEDURE This procedure should be followed if the calibration check is not correct The Calibration procedure is similar to the Calibration check but in this case the calibration factors expiratory and inspiratory will be recalculated as the average of all maneuvers performed and applied on the spirometer
44. nly valid for predicted values that calculates the LLN For example Hankinson Ferguson et al Office Spirometry for Lung Health Assessment in Adults Chest 2000 117 1146 1161 6 6 TRANSDUCERS RANGES AND MEASUREMENTS According to ATS ERS2005 Turbine Lilly Dispos Measurement Scale BTPS Flow O to 16 l s Volume Oto 101 lt 1 47 hPa 1 5 cmH20 l s a 14 Us Precision of measurements BPTS the highest value Volume 3 or 50 ml Flow 5 or 200 ml s PEF 10 or 300 ml s Transducer lifetime 1400 1400 Only one disinfect disinfect use Expir or 3 years or 3 years 3 years 6 7 MANUFACTURER S LIABILITY SIBEL S A is only liable for the safety reliability and working order of this equipment if e The place where the equipment is installed or used is compliant with the requirements related to the IEC electrical installation and other applicable regulations e All repairs services and modifications inside and outside the guarantee period are carried out by SIBEL S A technical staff 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual A TEE e The equipment is used by skilled staff according to the recommendations of this User s Manual 511 BOO MU2 e REV 1 06 belmed DATOSPIR TOUCH User s Manual SI 7 CLEANING AND MAINTENANCE DATOSPIR TOUCH spirometer requires cleaning and maintenance aimed at keeping the equipment functioning correctly and at ensuring safety of patient
45. ode OR Incentive for children and adults E tou Time audit enable disable show the time when the oe maneuver was performed e Predicted sets Choose predicted set among several authors for children and adults Prioritizes the age range selected for adults if a different table is chosen for children Extrapolates the values for the ages outside the selected table range Ethnic factor Observed parameters This is only at display level or for the report All the parameters are saved on the database and can be enabled at any time Graphs and report customization 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Save graphs on the database F V FVC Report V T FVC Report VC Report MVV Report D R Report Print large curves Print 3 curves PRE Print Data of 3 best maneuvers PRE BN x CA Interpretation Select diagnosis according to ATS ERS Miller Snider Kory Lyons or NLHEP Printing the interpretation gt Quality control alerts Display of quality alerts to assure compliance with ATS ERS EX ET or NLHEP criteria QC Prompts ao id Calibration check alerts Date of the last calibration Require a daily Calibration check Enable the use of the Spirometer without Calibration check Bronchodilation test customization leg Bronchoconstriction test customization See the Bronchoconstriction user s manual Pulse oximetry custo
46. of the meaning of the symbol and the precautions about discharge sensitivity 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual ELA IAS 1 2 GUIDANCE 8 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 eee Complian Electromagnetic environment Guidance RF Radiated emissions Group 1 DATOSPIR TOUCH uses RF energy only for its internal function CISPR 11 EN 55011 Class B Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Conducted emissions Group 1 DATOSPIR TOUCH uses RF energy only for its internal function CISPR 11 EN 55011 Class B Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions Class A EN IEC 61000 3 2 Voltage fluctuations Flicker Yes emissions EN IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR TOUCH is intended for use in the electromagnetic environment specified below The costumer or the user of DATOSPIR TOUCH should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge
47. or a USB separation device provided by the manufacturer SIBEL S A NEVER immerse any part of the equipment in liquid THIS COULD CAUSE AN ELECTRIC SHOCK Consult the section 7 1 RISKS OF EXPLOSION NOT suitable for use in the presence of volatile anesthetics flammable gases or in oxygen rich environments THIS MAY CAUSE AN EXPLOSION RISKS OF CONTAMINATION To avoid the risk of contamination or cross infection the Turbine and Fleisch transducers and some of the optional modules must be disinfected before use in a new patient or must be used with an adequate protective barrier filter compatible with the equipment see section 7 1 Reusable mouthpieces must also be disinfected Disposable transducers and disposable mouthpieces must NOT be reused DO NOT use mouthpieces or other supplies from manufacturers that have not tested their biocompatibility since it could endanger patient health RISKS OF INTERFERENCE This is an electronic medical device therefore requires special precautions regarding electromagnetic compatibility EMC it must be installed and put in service according to the information attached in Annex 1 ELECTROMAGNETIC COMPATIBILITY As this is an electronic product high frequency emissions may 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual interfere with its correct use Thus keep the spirometer away from products that may generate interference radios cell phones etc All
48. ormed press on its button m Im m m or m Ar BEST maneuver is set at Mi Therefore this will be used to display the interpretation to print the report or to save the maneuver The technician has the option to override this selection by pressing m m m m w me m or m 4 1 3 DELETING AN EXISTING MANEUVER Select the maneuver that you want to delete and press 4 1 4 SAVING A TEST TO THE INTERNAL DATABASE 1 Select the maneuver you wish to save The maneuver selected by default is the best M1 2 Press to save the best 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 n Press ZAM to view the interpretation According to the diagnosis available on your device s operating mode or depending on the customized option selected on the CONFIGURATION MENU Miller ATS ERS Snider Kory 8 Lyons or NLHEP 4 1 6 PRINTING A MANEUVER Print the test report via the internal or external printer Select the desired printer on the CUSTOMIZATION menu 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual Then select the maneuver to be printed and press Cd to print Cd the report of the maneuver selected and to print the report of the 3 best maneuvers if the Save 3 Maneuvers option is activated The report will include the parameters and graphs corresponding to the selected maneuver o 3 maneuv
49. pment has an internal diagnostic program to perform system checks and several adjustments DO NOT OPEN the instrument to carry out the maintenance program Doing so within the WARRANTY PERIOD WILL VOID THE WARRANTY Bo nal From the main screen press w and then Al The MAINTEANCE MENU options are Equipment s hardware Check up CPU ADCs check up Touch panel Printer Reindex the database Oe Reset all variables ATS curves pre saved checkup of the product with pre saved standard curves FVC VC MVV Calibration 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 transducer Enter the pre calibration code delivered by the After sales service with the new transducer to activate it and to load the corresponding 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual calibration factors Adding a new option Enter the new Activation code e delivered by the After sales service to enable the new option purchased Display the current activation code 3 5 QUALITY CONTROL CALIBRATION CHECK The 2005 ATS ERS TASK FORCE recommends that all spirometers be daily checked for calibration before further testing begins The possible aging or the accumulated dirt of transducers may do an inaccurate measure In the Pneumotachometers the relat
50. quipment 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 electrical discharge is provided by the connection of the chassis to an electrical earth connection The earth connection is only effective when the three wire power cable supplied with the equipment is connected to a suitably earthed electrical socket DO NOT use multiple mains sockets to NOT degrade the electrical safety DO NOT disassemble the equipment or accessories casing The device must only be serviced and repaired by skilled personnel The contact with voltage inside the device may cause serious injury DO NOT connect a line phone to the MIP MEP connector DO NOT use damaged accessories DO NOT use the equipment if the power cable is in poor condition or cracked 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual OAA ELECTRICAL DISCHARGE To ensure vital safety features under the EN 60601 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect DATOSPIR TOUCH to a non medical device as a printer or PC they must be compliant with EN60950 and the installation must provide an additional safeguard This 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
51. rnal power supply VD ON OU gt 11 Transducer holder 12 User s manual Included EE Optional ks Not included 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual EA SEEN Easy Diagnostic 2 2 4 ACCESSORIES OPTIONS AND SPARE PARTS D T F D T F REF OPTIONAL ACCESSORIES TRANSDUCERS KITS 07046 Disposable 07053 Turbine 07052 Fleisch OPTIONS 07272 Pulse oximetry module 07144 MIP MEP module 07146 Sniff module FIRMWARE OPTIONS 07060 Bronchoconstriction module 07061 Concurrent display of V t amp F V 07062 Database upgrade to 3000 records Diagnostic model Upgrade Includes weather station and Bluetooh modules ACCESORIES 02249 Calibration syringe 3 L 02692 Nose clip 5 u 01569 Plastic Mouthpiece 01555 Cartoon mouthpiece 28x60 100 u 03169 Disposable transducers 25 u 06391 SpO soft sensor adult M50B 07725 SpO soft sensor children M50E 02117 Antibacterial filter disposable 02118 Antibacterial filter reusable oo 02759 Antibacterial filter disposable membrane 50u MM EE Nen 03175 Turbine transducer Mi 07828 Software W20s CD SPARE PARTS AND COMPONENTS 07233 Weather station module 07193 Bluetooth module 06610 Ethernet module 02634 Thermal paper 110x50 5 u 07238 Rechargeable battery a 07283 Carrying Bag nn 01145 Bluetooth adapter for PC Enn 03658 USB 2 0 and printer cable connection 08165 Galvanic isolator for USB 2 0 07068 511 BOO MU2 e REV 1 06 Sib
52. ry between Fleisch transducers or between disposable transducers lots Verify that the factor entered into the equipment mathces with the one of the transducer that you are currently using 511 BOO MU2 REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 3 Enter the patient s details by pressing on each field An alphanumeric or numeric keyboard that will appear depending on the field data type required Enter patient s data and press If patient already exists in the database press to retrieve the patient s details from memory Once patient selected the patient s ID will appear at the top of the screen When finish press we to go to the test screen 3 Instruct the patient on the test performance his cooperation is essential for proper implementation A The test must be carried out by medical staff Review spirometry technique bibliography or request information about spirometry courses to SIBEL S A 4 When the patient is ready and have assumed a correct posture fit the nose clip The subject must hold the transducer without moving it and wait until a blinking arrow appears on the screen The transducer must remain in the same position until the end of the maneuver 5 Patients can carry out the spirometry maneuvers in either of two different ways 511 BOO MU2 e REV 1 06 belned DATOSPIR TOUCH User s Manual SI e Starting the maneuver with FORCED EXPIRATION followed by FORCED INSPIRATION if desired e
53. s and operators 7 1 CLEANING DISINFECTION The person who carries them out does not require any special technical knowledge other than their own understanding of the functioning and handling of the equipment It is usually done by the normal user of the equipment A 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 a wipe moistened with soapy neutral water or with 96 alcohol Then they can be wiped dry Take particular care to ensure that no liquid enters the interior of the device or the connectors and connections Do not use abrasive substances or solvents 7 1 2 CLEANING DISINFECTION OF THE TRANSDUCER A HIGH LEVEL DISINFECTION OF THE TRANSDUCERS The Fleisch and Turbine transducers must be disinfected before using them in a new patient specially if you suspect microbial contamination To do so proceed as follows A FLEISCH PNEUMOTACHOMETER 2 1 Remove the filter and then the transducer by pressing its tab so that it comes away Pp from its fixtures See the figure Sibelmed DATOSPIR TOUCH User s Manual 2 Immerse the transducer and filter in a CIDEX OPA solution follow the manufacturer s instructions Then rinse them in destilled water Do not use abrasive substances or solvents 3 Shake the transducer and filter for removing the water droplets leave them to dry at room
54. screen then shows the two graphs PRE and POST for comparison purposes 252C 760mmHg 603 fin 1 FYC POST i e s los 46 A MEN J H n Q 2 N W co Q N oo 0 2 4 6 8 10 12 14 16 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual The data screen shows the observed values in PRE and POST mode and the method of comparison between them depending on the option selected in the CUSTOMIZATION MENU e Weighted between PRE and POST e between REF Predicted and POST s between PRE and POST e Difference between PRE and POST Thus 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 screen 252c 760mntg 60 in 1 vc TV A Be ER EY 15 20 25 3 35 40 4 a a SEET e Theaxes are always displayed in VOLUME TIME mode e The equipment saves a maximum of 8 maneuvers ordered according to the VC value where M1 is the best VC and M8 the worst e The maximum time allowed for the maneuver is 45 seconds e To measure the ERV and TV parameters correctly each maneuver must have at least four respiratory cycles 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 4 5 MAXIMUM VOLUNTARY VENTILATION MVV TEST 1 Press from the main screen 2 Inhale and exhale completely without interruption for at least 1
55. sing the retrograde extrapolation method eEnd FVC expiration When the volume accumulated in the last second is below 25ml BRONCHODILATATION TEST e Same parameters and characteristics as in FVC e Several methods of comparison among PRE POST and REF values e Superimposing of PRE and POST graphs SLOW VITAL CAPACITY e VC l Slow vital capacity e TV l Tidal volume e ERV l Expiratory Residual Volume e IRV l Inspiratory Residual Volume e IC l Inspiratory Capacity e Ti s Inspiratory time e Te s Expiratory time 511 BOO MU2 e REV 1 06 belmed DATOSPIR TOUCH User s Manual SI e Tt s Total time e Ti Tt Ratio MAXIMUM VOLUNTARY VENTILATION e MVV I min Maximum Voluntary Ventilation e Br min Br min Breathing frequency of MVV 6 4 PREDICTED SETS The spirometer includes several predicted tables that the user can select in the CUSTOMIZATION MENU Spirometry Predicted set KNUDSON EEUU Gto8dew ZAPLETAL CSF EUROPE 4to17 MORRIS CF EEUU 24 to 100 POLGAR WENG 1 4t0100 CANDELA CST SPAIN ri 2to7 1 If other ages are used the predicted values are extrapolated 6 5 FVC INTERPRETATION Diagnosis e Miller chart e Snider Kory 8 Lyons 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual e Interpretation ATS ERS Pellegrino et al Task force Standardisation of Lung Function Testing Eur Respir J 2005 26 948 968 e Interpretation NLHEP O
56. tabase L Small DB gt 1000 tests including F V loops and V t curves H Large DB gt 3000 tests including F V loops and V t curves Storage of spirometry pulse oximetry and MIP MEP tests Communications PC USB 2 0 Bluetooth 2 0 op Ethernet op Printer USB 2 0 Bluetooth 2 0 op Printer protocol PCL 3 HPA PCL 5e Display high resolution touch screen LCD VGA of 640x480 Battery pack Ni Mh Rechargeable 9 6V 2 5Ah Operating Conditions Temperature 5 to 40 C Humidity lt 85 without condensation Pressure 850 to 1060 hPa 638 a 795 mmmHg 1500 a 0 m measurement 10 35 0C 17 35 C 30 75 sin condesad n 638 a 795 mmHg 1500 a Om aprox Temperature 20 to 70 C Humidity lt 85 without condensation Internal temperature 5to 40 QC 1 C sensor per subject Manuals of the modules Weather station Pressure 500 to 1040 hPa accuracy 6 67 hPa 375 to 780mmHg accuracy 5 mmHg Humidity 0 to 100 accuracy 5 Applicable standards European directive concerning medical devices 93 42 EEC RD 1591 2009 Quality EN ISO 13485 2012 AC 2012 EN ISO 9001 2008 and EN ISO 14971 2012 Compliance with data protection Act Directive 95 46 EC Safety Medical devices EN 60601 1 2006 AC 2010 Electro magnetic Compatibility EN 60601 1 2 2007 AC 2010 511 BOO MU2 e REV 1 06 aprox Peak Flow Forced expiratory ATS ERS Recomended EN ISO 23747 2007 volume Take Force Conditions er ME EN ISO 2678 2009
57. 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 I away from its fixtures 2 Immerse the turbine in a CIDEX OPA solution follow the manufacturer s instructions Then rinse the turbine by immersion in destilled water Do not rinse the turbine by holding it under running water Do not use abrasive substances or solvents 3 Given that the turbine reliability depends on its good condition examine it for possible damages A Leave it to dry at room temperature and re assemble the turbine in the housing When performing an intensive use of the spirometer it is recommended to have several transducers for replacing them while the used ones are being disinfected If a bacterial filter is used in conjunction with the Fleisch or Turbine transducers the CIDEX OPA solution indicated in Step 2 can be replaced by soapy neutral water C LILLY DISPOSABLE PNEUMOTACHOMETER This transducer does not need any kind of cleaning as they are 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual only for single use They must be thrown away once the patient has carried out the tests A Reutilization of the disposables transducers induces a risk of cross infection between patients The use of disinfectant products can affect the transducer s mesh inducing a loss of accuracy in the measurement D HANDLE AND TRANSDUCERS HOUSIN
58. the Bluetooth adapter user s manual Install the W20s Spirometry Software to the PC and choose the Bluetooth link option consult the W20s Spirometry Software User s Manual included in the CD The Bluetooth is enabled and disabled by accessing the Bluetooth option on the COMMON CUSTOMIZATION screen of the spirometer See section 3 2 3 Once the Bluetooth adapter has been configured in the PC a connection will be established every 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 the weather station module with the spirometer it will be ready to use Otherwise remove the bottom case of the spirometer and insert the weather station s board as shown in the figure 511 BOO MU2 e REV 1 06 Sibelmed d DATOSPIR TOUCH User s Manual 3 SPIROMETER CONFIGURATION 3 1 SETUP Press La and access to the options of the SETUP MENU ASA 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 LANGUAGE f ENGLISH Y Select the desired language to operate with the spirometer by pressing on the yellow square This mark vV will appear on the option selected Validate the selection by pressing a 511 BOO MU2 e RE
59. therefore wise to initially check its condition and that of its accessories before installing them If you detect any damage to the packaging contact the haulier agency and distributor immediately before starting the installation Packaging must not be disposed of until the correct working order of the device has been fully verified 2 4 1 START UP 1 Connect the external power supply to the socket no 9 located on the rear of the device and to the mains 2 Insert the plug of the transducer cord into the socket no 6 3 Connect the other optional modules that you have acquired Consult the specific user s manuals 4 Press the ON OFF button no 3 5 Choose the language 6 Enter the PIN number if equipment protection is enabled See the chapter 3 3 EQUIPMENT PROTECTION A The first time the equipment is started the protection is disabled and the PIN is set to 0000 7 If equipment protection is not enabled or if the correct PIN has been entered the MAIN MENU will then be displayed which varies according to the model 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual SSL IO O 25 C 760mmHg 25 C 760nnio 60 DIAGNOSTIC MODE DIAGNOSTIC MODE d e B 7 5 54 Le AO SIE Q Access to the FVC test Access to the Post Bronchodilation test Access to the VC test Access to the MVV test Access to the Bronchoconstriction test Access to the Pulse oximetry test Access to the MIP MEP t
60. will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN OOOO If an erroneous code is entered the equipment will remain locked 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 3 3 INTERNAL DATABASE The DATOSPIR TOUCH has an internal database to store the tests performed for later review print and or transfer to a computer using the W20s Spirometry Software or other computerized systems There are two storage capacities Database L 1000 tests Database H 3000 tests The database always saves all the spirometric parameters despite them not being selected in CUSTOMIZATION MENU Section 3 2 3 Ar is possible to save spirometric Bronchoconstriction MIP MEP or pulse oximetry test A The base information remains even when the equipment is turned off or the rechargeable battery is removed Press from the main menu Browse database Display of the registers saved Search patient by ID code or last name In addition you may e Display tests e Print tests e Delete tests Delete database Print summarized report of all the test saved into the database E Database customization e Number of records e Save 1 or 3 maneuvers in tests etc e Choose type of organization ID or last name 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 3 4 MAINTENANCE PROGRAM The equi
61. y of the files load them using EXCEL 5 If a problem is detected that the user is unable to solve send the 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual A li auto check information by e mail or fax to the SIBEL S A After sales Service or to your distributor who will analyze it and assess the cause of the problem providing or proposing a suitable solution 5 3 ADDING OPTIONS AND OR TRANSDUCER If you want to add a module option SpO5 MIP MEP bluetooth weather station bronchoconstriction etc and or a new transducer please contact the After sales Service who will send you the necessary components and the activation code Enter this code to the device by pressing on La from the main Se screen and then 43 MAINTEANCE MENU y Press Z to add a new transducer and or press new module option In both cases the following screen will appear where you must enter the activation code that will be delivered with the module or transducer 25 C 760mmHg 60 ACTIVATION CODE T B 13 40 Enter Code Serial number 511 BOO MU2 e REV 1 06 Sibelmed DATOSPIR TOUCH User s Manual 5 4 UPDATING FIRMWARE The Datospir TOUCH contains internal software firmware SIBEL SA carries out improvements on it continuously If you want to incorporate them into your spirometer and use the last version of the program contact After sales Service This will send you some files to

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