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Sibelmed DATOSPIR TOUCH User Manual
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Sibelmed DATOSPIR TOUCH User Manual

Sibelmed DATOSPIR TOUCH User Manual

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DATOSPIR TOUCH
USER'S MANUAL
511-B00-MU2 • REV. 2.02 • 2024-05

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  • Page 1 DATOSPIR TOUCH USER’S MANUAL 511-B00-MU2 • REV. 2.02 • 2024-05...
  • Page 2 Raimon Casellas, 6-8. 08205-Sabadell (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 Web: www.sibelmed.com COPYRIGHT No part of this publication may be reproduced, transmitted, transcribed,...
  • Page 3 touch DATOSPIR User’s Manual INDEX 1. SAFETY ..............6 1.1 INTENDED USE ............. 6 1.2 INTENDED USERS ............6 1.3 INDICATIONS FOR USE ..........7 1.4 INTENDED PATIENT POPULATION ........7 1.5 LIMITATIONS FOR USE ..........8 1.6 CONTRAINDICATIONS ........... 8 1.7 SIDE EFFECTS ..............
  • Page 4 touch DATOSPIR User’s Manual 3.7 CALIBRATION RECORD ..........37 4. SPIROMETRIC TESTS PROCEDURES ....37 4.1 FORCED VITAL CAPACITY «FVC» TEST ......38 4.1.1 ENTERING PATIENT DATA ..........38 4.1.2 DISPLAYING RESULTS AND OPTIONS ......42 4.1.3 DELETING AN EXISTING MANEUVER ......45 4.1.4 SAVING A TEST TO THE INTERNAL DATABASE ....45 4.1.5 VIEWING THE INTERPRETATION .........45 4.1.6 PRINTING A MANEUVER ..........46 4.1.7 OTHER TESTS ON THE SAME PATIENT ......46...
  • Page 5 touch DATOSPIR User’s Manual DATOSPIR TOUCH 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 TASK FORCE 2019 (American Thoracic Society/ European Respiratory Society) and National Institutions: SEPAR (Spanish Pneumology and Thoracic Surgery Society).
  • Page 6 touch DATOSPIR User’s Manual 1. SAFETY This user manual includes the necessary information for: - the use of the DATOSPIR (Easy-D, Easy-F, Easy-T, Diagnostic-D, TOUCH Diagnostic-F, Diagnostic-T) with the Transducer Module (Disposable, Fleisch or Turbine) to perform spirometry tests (measurement of lung flows and volumes), - and the DATOSPIR...

  • Page 7: Intended Patient Population

    touch DATOSPIR User’s Manual necessary for its operation is available in this Manual. For additional training on the techniques or on the product, contact SIBEL, S.A.U. or your dealer. 1.3 INDICATIONS FOR USE DATOSPIR is a portable desktop spirometer to measure the TOUCH amount (volume) and speed (flow) of air that a patient breathes in and out in a given time.

  • Page 8: Limitations For Use

    touch DATOSPIR User’s Manual The intended patient population for Maximal Respiratory Pressures testing is defined in the MIP-MEP Module User’s Manual. 1.5 LIMITATIONS FOR USE An analysis of the results of spirometry or maximum pressures 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.

  • Page 9: Residual Risks

    touch DATOSPIR User’s Manual the specified accuracy and/or indicating that the manoeuvre is not correct), the display of results, saving and integrity of data in memory. It is not considered essential performance the communication with the computer nor the printing of the results. 1.9 RESIDUAL RISKS According to the application of the EN ISO 14971 standard, all risks related to the use of the...
  • Page 10 touch DATOSPIR User’s Manual from circulating around it while it is running. The equipment should NOT be used adjacent to or stacked with other equipment. 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.
  • Page 11 DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION Never dispose the DATOSPIR TOUCH, the Modules, its accessories and/or 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.

  • Page 12: Instructions For Installation

    2. INSTRUCTIONS FOR INSTALLATION 2.1 INTRODUCTION DATOSPIR is a compact device based on different types of TOUCH 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.

  • Page 13: Models And Operating Modes

    touch DATOSPIR User’s Manual 2.2 MODELS AND OPERATING MODES DATOSPIR series is available in 6 different models TOUCH • DATOSPIR EASY-T • DATOSPIR DIAGNOSTIC-T TOUCH TOUCH • DATOSPIR EASY-F • DATOSPIR DIAGNOSTIC-F TOUCH TOUCH • DATOSPIR EASY-D • DATOSPIR DIAGNOSTIC-D TOUCH TOUCH This manual is intended for all models and options of the...

  • Page 14: Operating Modes

    USB to PC Bluetooth module Included Optional Not included 2.2.1 OPERATING MODES There are 3 operating modes available. Choose the settings that best fit your needs: • 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.
  • Page 15 touch DATOSPIR User’s Manual DIAG FUNCTIONALITIES Bronchodilation (Post) Bronchoconstriction Alternated V-T & F-V plots Simultaneous V-T & F-V plots 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...

  • Page 16: Packing List

    2.2.2 PACKING LIST Easy Diagnostic TRANSDUCERS 1. Disposable transducer module 2. Turbine transducer module 3. Fleisch transducer module ACCESSORIES STANDARD 4. Thermal paper 110x50 (2 u) 5. USB and printer cable connection 6. Nose clip (5 u) 7. Bacterial-viral filter (5 u) 8.
  • Page 17 touch DATOSPIR User’s Manual 2.2.3 OTHER PRODUCTS, ACCESSORIES OR SPARE PARTS Easy Diagnostic COD. TRANSDUCER MODULES 09888 Disposable transducer module 09890 Turbine transducer module 09889 Fleisch transducer module OPTIONS 09891 PIM-PEM module (includes probe 03052 and mouthpiece 09803) FIRMWARE OPTIONS 07060 Bronchoconstriction module 07061...

  • Page 18: Rear Pannel

    2.3 LAYOUT OF CONTROLS AND CONNECTORS FRONT PANNEL REAR PANNEL BASE Do not connect any product, accessory or component not provided by SIBEL,S.A.U. 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).

  • Page 19: Installation And Start-Up

    touch DATOSPIR User’s Manual 2.4 INSTALLATION AND START-UP This device 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 therefore wise to initially check its condition and that of its accessories before installing them.

  • Page 20: Equipment Protection

    Enter the PIN number, if equipment protection is enabled. See the chapter 3.2.4 EQUIPMENT PROTECTION. The first time the equipment is started, the protection is disabled and the PIN is set to 0000. If equipment protection is not enabled or if the correct PIN has been entered, the MAIN MENU will then be displayed, which varies...
  • Page 21 touch DATOSPIR User’s Manual Access to the Bronchoconstriction test Access to the MIP-MEP test Quality control procedure: Calibration check Access to the Internal database/ Database customization Printing a report Access to the Setup options: Calibration, Customization and Maintenance. Pressing on the black area of the screen you may enable / disable the main menu buttons.

  • Page 22: Power Saving

    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.

  • Page 23: Usb Connection To Pc

    touch DATOSPIR User’s Manual 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.
  • Page 24 Then, in both cases, connect the Bluetooth adapter to the PC and simply install the software included. To do so, consult 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...

  • Page 25: Device Configuration

    touch DATOSPIR User’s Manual 3. DEVICE 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 device, by pressing on the yellow square.
  • Page 26 The device has been developed to make it user-friendly. Ease of use is assured through context sensitive help screens that explain every DATOSPIR TOUCH feature, by touching this icon Touch this icon to adjust brightness. Reloj – Calendario: Pulse encima de este icono para ajustar la hora y la fecha.
  • Page 27 touch DATOSPIR User’s Manual 3.2.3 PERSONALIZACIÓN COMÚN 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 memorizes a user-defined customization program status.
  • Page 28 touch DATOSPIR User’s Manual Main menu icons (enable/disable) Equipment Protection code (PIN) Bluetooth: (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 of the report in accordance with the recommendations of the program CWHSP of the US National Institute for Occupational Safety and Health (NIOSH).
  • Page 29 touch DATOSPIR 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 according to ATS/ ERS, Miller, Snider/Kory/Lyons or NLHEP.

  • Page 30: Enter Pin

    touch DATOSPIR User’s Manual Press 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. 3.2.4 EQUIPMENT PROTECTION In compliance with the General Data Protection Regulation, the DATOSPIR has a protection option accessed by a PIN of 4 TOUCH...

  • Page 31: Internal Database

    touch DATOSPIR User’s Manual 3.3 INTERNAL DATABASE DATOSPIR has an internal database to store the tests TOUCH 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»...

  • Page 32: Maintenance Program

    touch DATOSPIR User’s Manual Database customization: • Number of records • Save 1 or 3 maneuvers in tests, etc. • Choose type of organization (ID or last name) 3.4 MAINTENANCE PROGRAM The equipment has an internal diagnostic program to perform system checks and several adjustments.
  • Page 33 touch DATOSPIR User’s Manual 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 calibration factors. Adding a new option.
  • Page 34 touch DATOSPIR User’s Manual Test procedure: Couple the transducer to the outlet port of the syringe (between 3 and 6 L): Power up the DATOSPIR and press from the main TOUCH menu. Discharge the syringe once at every one of the following flow rates between 0-12L/s: Low flow level: 0,4 –...
  • Page 35 touch DATOSPIR User’s Manual To simplify the procedure, the spirometer allows you to carry out a single maneuver at Mid-flow level: 2 - 5 l/s. Press to cancel the maneuver or pto accept it and go to the next range of flow. At the end of the operation, press to see the results of the maneuvers performed: the percentages of variation and calibration...

  • Page 36: Calibration Procedure

    touch DATOSPIR User’s Manual menu, to require a daily calibration check before allowing access to any test. By default, this option is disabled. 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.

  • Page 37: Calibration Record

    touch DATOSPIR User’s Manual 3.7 CALIBRATION RECORD The spirometer has a record containing the information of the last 350 calibrations check and calibrations performed, indicating: date, time, volume accuracy percentage and average 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.

  • Page 38: Entering Patient Data

    touch DATOSPIR User’s Manual 4.1 FORCED VITAL CAPACITY «FVC» TEST 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 Fleisch disposable turbine Turn on the device and press on the Main Screen.
  • Page 39 touch DATOSPIR User’s Manual Patient identifier, 10-character alphanumeric. 20-character alphanumeric field Name: 25-character alphanumeric field Surname: 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 40 touch DATOSPIR User’s Manual on the field data type required. Enter patient’s data and pres 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 To achieve high quality results, always use the nose clip.
  • Page 41 touch DATOSPIR User’s Manual • Starting the maneuver with FORCED EXPIRATION followed by 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 42 touch DATOSPIR User’s Manual 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 sum of FVC+FEV1 is considered the best. Perform at least 3 maneuvers, but no more than 8, as this would tire the patient.
  • Page 43 touch DATOSPIR User’s Manual PRED: indicates the patient’s Predicted value *: indicates the current maneuver Mx: indicates the selected maneuver 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.
  • Page 44 touch DATOSPIR User’s Manual in the reports for a further monitoring. • Press on ID area to access the patient’s data Screen. • Press the to display all parameters data of maneuvers performed. • Observed values of the parameters selected in the CUSTOMIZATION MENU.
  • Page 45 touch DATOSPIR User’s Manual The screen only displays the results of 3 maneuvers and the predicted. By default, it appears the data of the 3 best maneuvers: . To view the data of the other maneuvers performed, press on its button: The BEST maneuver is set at M1.
  • Page 46 touch DATOSPIR User’s Manual 4.1.6 PRINTING A MANEUVER Print the test report via the internal or external printer. Select the desired printer on the CUSTOMIZATION menu. Then, select the maneuver to be printed and press to print the report of the maneuver selected and to print the report of the 3 best maneuvers, if the “Save 3 Maneuvers”...
  • Page 47 touch DATOSPIR User’s Manual 4.1.8 CHANGING PATIENT DATA/ ENTER A NEW PATIENT This option allows you to enter a new patient data or to 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.
  • Page 48 touch DATOSPIR User’s Manual 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).
  • Page 49 touch DATOSPIR User’s Manual 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? patient must start exhaling Don't Hesitate EX error harder.
  • Page 50 touch DATOSPIR User’s Manual GRADE TEST CRITERIA At least 2 acceptable maneuvers with the largest 2 FEV1 values matching within 100mL VERY GOOD and the largest 2 FEV6 values matching better than 100mL. At least 2 acceptable maneuvers with FEV1 GOOD values matching between 101 and 150mL At least 2 acceptable maneuvers with FEV1...
  • Page 51 touch DATOSPIR 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 52 touch DATOSPIR 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 53 touch DATOSPIR 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 54 touch DATOSPIR User’s Manual Comunication can be made via USB (standard) or Bluetooth (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: Save the tests required in the device’s internal Database Install the W20s Spirometry Software, as detailed in its...
  • Page 55 touch DATOSPIR User’s Manual Ejecutar el Software W20s, previamente instalado. Run the previously installed W20s Spirometry Software, making ” is selected in Configuration - Links sure that “DATOSPIR TOUCH 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...

  • Page 56: Updating Firmware

    touch DATOSPIR User’s Manual Press to add a new transducer and / or press 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.
  • Page 57 touch DATOSPIR User’s Manual Hardware Test option. Run a communications test to check that the connections are correct Access the Configuration - Utilities - Update Flash option. A dialogue box will be opened. Next step number 5 is only necessary to update from version 1.07 to a new version.
  • Page 58 touch DATOSPIR User’s Manual 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: •...

  • Page 59: Technical Specifications

    touch DATOSPIR User’s Manual 6. TECHNICAL SPECIFICATIONS 6.1 GENERAL SPECIFICATIONS Input 100 to 240VAC, 50 - 60Hz Power supply Output 12V 2.5 A (Electrical Protection: Class I) Compatible - MEANWELL GSM40A12 external power - DANUBE FRM030-S124 supplies Medical device Clase IIa classification Dimensions 195 x 270 x 100mm...
  • Page 60 Max. Nº of maneuvers per 8 FVC maneuvers, 8 VC maneuvers, 8 MVV maneuvers subject 7 years (see section 6.6 for each transducer and the User’s Manuals of Device lifetime the modules) Pressure: 500 to 1040 hPa, accuracy: ± 6.67 hPa Weather station (375 to 780mmHg, accuracy: ±...
  • Page 61 touch DATOSPIR 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 MOISTURE LIMITATION PRESSURE LIMITATION PRECAUTION WARNING, IDENTIFIED RISK MEDICAL DEVICE START-UP (STANDBY) BF APPLIED PART WASTE DISPOSAL ACCORDING THE WAEE DIRECTIVE INPUT (EXTERNAL POWER SUPPLY)

  • Page 62: Forced Vital Capacity Fvc

    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 63 touch DATOSPIR User’s Manual • FIV1/FIVC (%) Ratio • FEV1/FIV1 (%) Ratio • PIF (l/s) Inspiratory Flow Apex • MTT (s) Mean Transit Time • PEF/PIF (-) Ratio • BEV (%) Extrapolated Volume • MVVInd (l/min) Maximum Voluntary Ventilation (30 x FEV1) •...
  • Page 64 • Tt (s) Total time • Ti/Tt (-) Ratio 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.
  • Page 65 touch DATOSPIR User’s Manual 6.5 FVC INTERPRETATION (DIAGNOSIS) • Miller chart • Snider, Kory & Lyons • Interpretation ATS/ERS. Pellegrino et al. Task force: Standardisation of Lung Function Testing. Eur Respir J 2005; 26: 948–968 • Interpretation NLHEP. (Only valid for predicted values that calculates the LLN.
  • Page 66 6.7 MANUFACTURER’S LIABILITY SIBEL, S.A.U. is only liable for the safety, reliability and working order of this equipment if: • The place where the equipment is installed or used is compliant with the requirements related to the IEC electrical installation and other applicable regulations.

  • Page 67: Cleaning And Maintenance

    touch DATOSPIR User’s Manual 7. CLEANING AND MAINTENANCE DATOSPIR requires cleaning and maintenance aimed at TOUCH 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 68 A) FLEISCH PNEUMOTACHOMETER Remove the filter and then the transducer by pressing its tab so that it comes away from its fixtures. See the figure. . Immerse the transducer and filter in a Orthophthaldehyde solution (CIDEX® OPA), or in a disinfectant solution based on peracetic acid, hydrogen peroxide or N-Duopropenide according to the concentration defined by the...
  • Page 69 touch DATOSPIR User’s Manual Do not use abrasive substances or solvents. Then rinse the turbine by immersion in distilled water. Do not rinse the turbine by holding it under running water. Given that the turbine reliability depends on its good condition, examine it for possible damages.

  • Page 70: Preventive Maintenance

    Keep the device firmware up to date. Check the BIOS and program version on the startup screen. Check the availability of new versions at https://www.sibelmed.com/support In the event of detecting any problem that the user cannot solve, contact the SIBEL S.A.U.

  • Page 71: Corrective Maintenance

    On detecting any fault with equipment which interferes with its normal use, disconnect the equipment from the mains and contact SIBEL S.A.U. After-Sales Service. Specify the problem in as much detail as possible. SIBEL S.A.U. After-Sales Service Tel. +34 93 433 54 50 e-mail: sat@sibelmed.com 511-B00-MU2 • REV. 2.02...

  • Page 72: Annex 1. Electromagnetic Compatibility

    Annex 1. ELECTROMAGNETIC COMPATIBILITY 1.1. GUIDANCE & MANUFACTURER’S DECLARATION Guidance and manufacturer’s declaration – electromagnetic emissions TOUCH is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in DATOSPIR such an environment.
  • Page 73 touch DATOSPIR User’s Manual Guidance and manufacturer’s declaration – electromagnetic immunity TOUCH is intended for use in the electromagnetic environment specified below. The costumer or the user of TOUCH DATOSPIR DATOSPIR should assure that it is used in such an environment. Below mentioned tests are applicable to enclosure.

  • Page 74: Important Warning

    • The observance of the recommendations included in this section does not guarantee, in any case, the complete adequacy of the user’s activity to the regulation on data protection. CONFIGURATION OF DATOSPIR TOUCH PROTECTION DATOSPIR has a device protection option that uses a PIN...
  • Page 75 touch DATOSPIR 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 to data.

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