Sibelmed DATOSPIR TOUCH Series User Manual
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Sibelmed DATOSPIR TOUCH Series User Manual

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DATOSPIR TOUCH
SPIROMETER
USER'S MANUAL
511-B00-MU2 • REV. 1.09 • 2019-05

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  • Page 1 DATOSPIR TOUCH SPIROMETER USER’S MANUAL 511-B00-MU2 • REV. 1.09 • 2019-05...
  • Page 2 SIBEL S.A.U., Rosellón 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 511-B00-MU2 •...

  • Page 3: Table Of Contents

    DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 1. SAFETY ................5 2. INSTRUCTIONS FOR USE AND INSTALLATION..... 10 2.1 INTRODUCTION ............10 2.2 MODELS AND OPERATING MODES....... 10 2.3 LAYOUT OF CONTROLS AND CONNECTORS ....15 2.4 INSTALLATION AND START-UP ........16 3.
  • Page 4 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual The DATOSPIR TOUCH Spirometer has been designed by the R+D+I Department of SIBEL S.A.U., 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...

  • Page 5: Safety

    DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 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.
  • Page 6 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 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 supervised qualified technician in the art. Before using the spirometer on patients, you should be familiar with the operation of equipment.
  • Page 7 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 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. The device should NOT be used stacked or adjacent to other equipment.
  • Page 8 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual It is considered essential performance the measurement parameters related with spirometry (flow and volume), maximal pressures and pulse oximetry (fulfilling the specified accuracy and/or indicating that the maneuver is not correct), the display of results, saving and integrity of data in memory.
  • Page 9 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 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.

  • Page 10: Instructions For Use And Installation

    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:  DATOSPIR TOUCH EASY - T  DATOSPIR TOUCH DIAGNOSTIC - T ...
  • Page 11 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 11 1 The spirometer has three possible different transducers:  Turbine Transducer  Fleisch Transducer  Disposable Transducer (Lilly type) And two software configuration choices:  Easy – for occupational and primary care ...
  • Page 12 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 12 1  Diagnostic Mode (DG): Orientated Lung Function Laboratories. This is the most complete mode. Practically all the functionalities of the device are available and it allows you to perating mode. whatever o ...
  • Page 13 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 13 1 A model can be upgraded at any time by adding the corresponding parts. To do so, please contact the SIBEL S.A.U. Sales Department or your dealer. 2.2.3 PACKING LIST Easy Diagnostic TRANSDUCERS 1.
  • Page 14 DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 14 1 Easy Diagnostic 2.2.4 ACCESSORIES, OPTIONS AND SPARE PARTS 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...

  • Page 15: Layout Of Controls And Connectors

    DATOSPIR TOUCH User’s Manual DATOSPIR TOUCH User’s Manual 15 1 2.3 LAYOUT OF CONTROLS AND CONNECTORS FRONT PANNEL REAR PANNEL BASE Do not connect accessories not supplied by SIBEL,S.A.U. 1- Internal printer (thermal paper roll). 10- USB connector for PC 2- Lever to lock/unlock the paper roll.

  • Page 16: Installation And Start-Up

    DATOSPIR TOUCH User’s Manual 2.4 INSTALLATION AND START-UP This spirometer 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 therefore wise to initially check its condition and that of its accessories before installing them.
  • Page 17 DATOSPIR TOUCH User’s Manual 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 test Quality control procedure: Calibration check Access to the Internal database/ Database customization Printing a report...
  • Page 18 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 ≥2000mAh) with autonomy of 1.5 hours approx.
  • Page 19 DATOSPIR TOUCH User’s Manual 2.4.4 PLACEMENT OF THE PAPER INTO THE INTERNAL PRINTER Lift the printer cover and press the tab located on the right-hand side of the printer to unlock the cylinder. Place the paper roll into its housing and pull out about 20 cm of paper towards the unit screen, ensuring that it is properly aligned.
  • Page 20 DATOSPIR TOUCH User’s Manual 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.
  • Page 21 DATOSPIR TOUCH User’s Manual The Bluetooth is enabled (and disabled) by accessing the Bluetooth option on the screen of the spirometer. COMMON CUSTOMIZATION (See section ). Once the Bluetooth adapter has been 3.2.3 configured in the PC, a connection will be established every time the equipment and the PC are started.

  • Page 22: Spirometer Configuration

    DATOSPIR TOUCH User’s Manual 3. SPIROMETER CONFIGURATION 3.1 SETUP Press and access to the options of the SETUP MENU: 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 operate with the spirometer, by pressing on the yellow square.
  • Page 23 DATOSPIR TOUCH User’s Manual 3.2.2 TOOLBAR CUSTOMIZATION 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;...
  • Page 24 DATOSPIR TOUCH User’s Manual 3.2.3 COMMON CUSTOMIZATION If you wish to change any logging parameter, do so under this menu. Access this option by pressing from the main screen, and then The options included in the CUSTOMIZATION MENU are: Default Configuration: This option...
  • Page 25 DATOSPIR TOUCH User’s Manual Bluetooth: (enable/disable) Ethernet: (enable/disable) Initial customization: main menu icons, spirometry parameters, units, predicted, interpretation, incentive chart, pin, printer configuration and report header. Spirometry customization Select the Operating mode Selection of mode NIOSH. Enables the check and printing report accordance...
  • Page 26 DATOSPIR TOUCH User’s Manual Graphs and report customization: Save graphs on the database F/V- FVC Report V/T- FVC Report VC Report MVV Report D/R Report Present ZSCORE Print large curves Print 3 curves PRE Print Data of 3 best maneuvers PRE Interpretation: Select diagnosis...

  • Page 27: Internal Database

    DATOSPIR TOUCH User’s Manual 3.2.4 EQUIPMENT PROTECTION compliance with 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.

  • Page 28: Maintenance Program

    DATOSPIR TOUCH User’s Manual 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 from the CUSTOMIZATION MENU (Section 3.2.3). possible save spirometric, Bronchoconstriction, MIP-MEP or pulse oximetry test.
  • Page 29 DATOSPIR TOUCH User’s Manual From the main screen, press and then MAINTEANCE options are: MENU Equipment’s hardware Check-up: ADCs check-up Touch panel Printer Reindex the database Reset all variables ATS curves pre-saved: checkup of the product with pre-saved standard curves FVC, VC, MVV Calibration and/or maintenance alerts.

  • Page 30: Quality Control: Calibration Check

    DATOSPIR TOUCH User’s Manual 3.5 QUALITY CONTROL: CALIBRATION CHECK recommends that all spirometers 2005 ATS/ERS TASK FORCE be daily checked for calibration, before further testing begins. The possible aging or the accumulated dirt of transducers may do inaccurate measure. Pneumotachometers, the relationship between the pressure drop and the airflow depends on the gas viscosity.
  • Page 31 DATOSPIR TOUCH User’s Manual Discharge the syringe once at every one of the following flow rates 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 To simplify the procedure, the spirometer allows you to carry out a single maneuver at Mid-flow level: 2 - 5 l / s.

  • Page 32: Calibration Procedure

    DATOSPIR TOUCH User’s Manual If the session is correct, the results will be automatically saved to the calibration record. Press to see the data of the record (See section 3.7). Once calibration check performed satisfactorily, access the Spirometry program to begin the tests. If the calibration check is not correct, do a full calibration of the instrument.

  • Page 33: Calibration Record

    DATOSPIR TOUCH User’s Manual To simplify the Calibration procedure, the spirometer allows you to carry out at least 3 maneuvers at Mid-flow level: 2- 5 l/s. To carry out the calibration procedure, press and then Enter necessary data described below follow instructions detailed in the section 3.6.
  • Page 34 DATOSPIR TOUCH User’s Manual 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 desired. 511-B00-MU2 • REV. 1 .09...

  • Page 35: Spirometric Tests Procedures

    DATOSPIR TOUCH User’s Manual 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»...
  • Page 36 DATOSPIR TOUCH User’s Manual 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:...
  • Page 37 DATOSPIR TOUCH User’s Manual Enter patient’s details pressing each field. alphanumeric 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 retrieve patient’s details from memory.
  • Page 38 DATOSPIR TOUCH User’s Manual Patients can carry out the spirometry maneuvers in either of two different ways:  Starting maneuver with FORCED EXPIRATION followed FORCED INSPIRATION, if desired.  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.
  • Page 39 DATOSPIR TOUCH User’s Manual 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.
  • Page 40 DATOSPIR TOUCH User’s Manual • Press to enlarge or reduce the graph. • 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. • Selection of the desired maneuver Mx: the scroll allows you to move over the maneuvers performed and select the desired...
  • Page 41 DATOSPIR TOUCH User’s Manual • Press the to display all parameters data of maneuvers performed.  Observed values of the parameters selected in the CUSTOMIZATION MENU.  Predicted values <REF> (If patient’s data has been filled in)  % between both parameters. If an * appears after the REF test, this means that the predicted values have been extrapolated ...
  • Page 42 DATOSPIR TOUCH User’s Manual The BEST maneuver is set at M1. 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 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...
  • Page 43 DATOSPIR TOUCH User’s Manual The report will include the parameters and graphs corresponding to the selected maneuver o 3 maneuvers. If you do not want graphs, certain parameters, the diagnosis and/or ATS/ERS warnings to appear, disable them on the CUSTOMIZATION MENU. Moreover, by pressing in the Main menu you may print: The last test performed...

  • Page 44: Quality Of Fvc Test

    DATOSPIR TOUCH User’s Manual 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 CUSTOMIZATION 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.
  • Page 45 DATOSPIR TOUCH User’s Manual II. NLHEP ALERTS: QC PROMPTS 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.
  • Page 46 DATOSPIR TOUCH User’s Manual QC Prompt Criteria How to improve the maneuver? The patient must start exhaling Don't Hesitate EX error harder. Blast Out Time to PEF higher than The patient must exhale as Faster 120ms hard, firm and fast as possible. The patient has abruptly interrupted exhalation.

  • Page 47: Post Bronchodilation Test

    DATOSPIR TOUCH User’s Manual GRADE TEST CRITERIA At least 2 acceptable maneuvers with FEV values ACCEPTABLE matching between 151 and 200 mL Only one acceptable maneuver, or more than POOR one, but the FEV values match > 200 ml (with no interpretation) NOT ACCEPTABLE No acceptable maneuvers (with no interpretation)
  • Page 48 DATOSPIR TOUCH User’s Manual Select the PRE test with which to be compared and press (FVC selected by default). Using keys , the VC and MVV tests can be seen and saved in PRE mode. The screen then shows the two graphs (PRE and POST) for comparison purposes: 511-B00-MU2 •...

  • Page 49: Slow Vital Capacity "Vc" Test

    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.  Weighted % between PRE and POST  % between REF (Predicted) and POST ...

  • Page 50: Maximum Voluntary Ventilation "Mvv" Test

    DATOSPIR TOUCH User’s Manual 4.5 MAXIMUM VOLUNTARY VENTILATION «MVV» TEST Press , from the main screen. 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. •...

  • Page 51: Communications System

    DATOSPIR TOUCH User’s Manual 5. COMMUNICATIONS SYSTEM One of the strengths of the DATOSPIR TOUCH spirometer is its Communications System, which allows the user to: Transfer patient tests to a PC Transfer Equipment Checking Data Update Internal Software Export patient tests to other Management Systems Communications can be made via USB (standard), Bluetooth (optional) or Ethernet (optional).

  • Page 52: Adding Modules, Options And/Or Transducer

    DATOSPIR TOUCH User’s Manual Start up the spirometer, press from the main menu and select . Access the Equipment Check option and MANITENANCE run all the sub options, following the instructions on the screen. Connect the equipment and the PC via USB or Bluetooth. Run the previously installed W20s Spirometry Software, making sure...

  • Page 53: Updating Firmware

    DATOSPIR TOUCH User’s Manual Press to add a new transducer and / or press to activate a 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. 5.4 UPDATING FIRMWARE The Datospir TOUCH contains internal software (firmware).
  • Page 54 DATOSPIR TOUCH User’s Manual 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. Select now in the computer the file Load.prj and press again the button “Send”.

  • Page 55: Technical Specifications

    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 I) Compatible external  MEANWELL GSM40A12 power supplies  EMERSON DP4012N3M  DANUBE FRM030-S124 Medical device Class IIa classification...
  • Page 56 DATOSPIR TOUCH User’s Manual  Electromagnetic Compatibility EMC – Healthcare Environment (EN 60601-1-2:2015)  Biocompatibility: Biological evaluation of medical devices. (EN ISO 10993-1: 2009+AC: 2010)  Usability (EN 60601-1-6:2010+A1:2015)  Usability (EN 62366:2008+A1:2015)  Spirometers forced spiratory volumes measurement (EN ISO 26782:2009+AC:2009) ...

  • Page 57: Symbols

    DATOSPIR TOUCH User’s Manual 6.2 SYMBOLS SERIAL NUMBER MANUFACTURER’ (Manufacturing date, manufacturer’s name and address) LOT NUMBER PRODUCT REFERENCE EXPIRATION DATE DO NOT REUSE TEMPERATURE 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 ALARMS...

  • Page 58: Tests, Functions And Parameters

    DATOSPIR TOUCH User’s Manual 6.3 TESTS, FUNCTIONS AND PARAMETERS Available Information on tests: Percentage deviation in relation to predicted values.  Standardized values of predicted that can be selected from  several standards. Patient’s ID details.  Atmospheric data on temperature, pressure and relative humidity. ...
  • Page 59 DATOSPIR TOUCH User’s Manual MTT (s) Mean Transit Time  PEF/PIF (-) Ratio  Vext (%) Extrapolated Volume  MVVInd (l/min) Maximum Voluntary Ventilation (30 x FEV1)  FEV6 (l) Forced Expiratory Volume in 6seconds  FEV1/FEV6 (%) Ratio  EPOC rate Parameter that depends on the number of cigarettes ...

  • Page 60: Predicted Sets

    DATOSPIR TOUCH User’s Manual MAXIMUM VOLUNTARY VENTILATION MVV (l/min) Maximum Voluntary Ventilation  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 Contry / Age range (years) Region...

  • Page 61: Transducers

    DATOSPIR TOUCH User’s Manual  Interpretation NLHEP. (Only 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) Fleisch Turbine Lilly...

  • Page 62: Cleaning And Maintenance

    DATOSPIR TOUCH User’s Manual 7. CLEANING AND MAINTENANCE DATOSPIR TOUCH spirometer requires cleaning and maintenance aimed at keeping the equipment functioning correctly and at ensuring safety of patients 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.
  • Page 63 DATOSPIR TOUCH User’s Manual A) FLEISCH PNEUMOTACHOMETER Remove the filter and then the transducer by pressing its tab so that comes away from fixtures. See the figure. Immerse the transducer and filter in a CIDEX® OPA solution (follow the manufacturer's instructions). Then rinse them in destilled water.

  • Page 64: Preventive Maintenance

    DATOSPIR TOUCH User’s Manual 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®...
  • Page 65 DATOSPIR TOUCH User’s Manual 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 equipment. Check that all connections are perfectly connected, that no cable and/or connector or any other element is broken or damaged.

  • Page 66: Corrective Maintenance

    DATOSPIR TOUCH User’s Manual 7.3 CORRECTIVE MAINTENANCE Corrective maintenance consists of repairing 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 equipment from the mains and contact SIBEL S.A.U.

  • Page 67: Annex 1. Electromagnetic Compatibility

    DATOSPIR TOUCH User’s Manual Annex 1. ELECTROMAGNETIC COMPATIBILITY 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 Emissions test Emissions test...
  • Page 68 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. Tests EN-IEC 61000-4-4 y -4-5 are applicable to AC/DC power inputs, and input/output signal.
  • Page 69 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. Below mentioned tests are applicable to enclosure.
  • Page 70 DATOSPIR TOUCH User’s Manual Proximity fields EN-IEC 61000-4-3 Frecuency Band Modulation Power Distance (MHz) (MHz) (V/m) 380-390 Pulse 18Hz 430-470 D:+/-5kHz 1kHz sinus 704-787 Pulse 217Hz 800-960 Pulse 18Hz 1720 1845 1700-1990 Pulse 217Hz 1970 2450 2400-2570 Pulse 217Hz 5240 5500 5100-5800 Pulse 217Hz...

  • Page 71: Act

    DATOSPIR TOUCH User’s Manual Annex 2. COMPLIANCE WITH THE DATA PROTECTION ACT REQUIREMENTS AFFECTING THE USER OF THE EQUIPMENT This section is aimed at facilitating the user to comply with the regulation in force related to the treatment of personal data that are regulated and covered by REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing...
  • Page 72 DATOSPIR TOUCH User’s Manual  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.

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