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Related Manuals for Sibelmed DATOSPIR TOUCH EASY - F
Summary of Contents for Sibelmed DATOSPIR TOUCH EASY - F
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Page 1: Datospir Touch User's Manual 3
DATOSPIR TOUCH SPIROMETER USER’S MANUAL 511-B00-MU2 • REV. 1.02 • 2011/09... - Page 2 DATOSPIR TOUCH User’s Manual SIBEL S.A., Rosselló 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...
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Page 3: Table Of Contents
DATOSPIR TOUCH User’s Manual 1. SAFETY…………………………………………………………… 5 2. INSTRUCTIONS FOR USE & INSTALLATION ..….…… 10 2.1. INTRODUCTION …………………………………………………………………… 10 2.2. MODELS AND OPERATING MODES ……………………………………… 10 2.3. LAYOUT OF CONTROLS AND CONNECTORS ……………………… 17 2.4. INSTALLATION AND START-UP …………………………………………… 18 3. - Page 4 DATOSPIR TOUCH User’s Manual 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...
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Page 5: Safety
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 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.
- Page 7 DATOSPIR TOUCH User’s Manual 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.
- Page 8 DATOSPIR TOUCH User’s Manual 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.
- Page 9 DATOSPIR TOUCH User’s Manual 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.
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Page 10: Instructions For Use & Installation
The DATOSPIR TOUCH series is available in 6 different models: • DATOSPIR TOUCH EASY - T • DATOSPIR TOUCH DIAGNOSTIC - T • DATOSPIR TOUCH EASY - F • DATOSPIR TOUCH DIAGNOSTIC - F • DATOSPIR TOUCH EASY - D • DATOSPIR TOUCH DIAGNOSTIC - D This manual is intended for all models and options of the DATOSPIR TOUCH spirometer. - Page 11 DATOSPIR TOUCH User’s Manual The following table shows the standard features and optional functions for each model. The spirometer has three possible different transducers: • Turbine Transducer • Fleisch Transducer • Disposable Transducer (Lilly type) And two software configuration choices: •...
- Page 12 DATOSPIR TOUCH User’s Manual 2.2.2. OPERATING MODES There are 3 operating modes available. Choose the settings that best fit your needs: • 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.
- Page 13 DATOSPIR TOUCH User’s Manual DIAG FUNCTIONALITIES Bronchodilatation (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 14 DATOSPIR TOUCH User’s Manual 2.2.3 ACCESSORIES Easy Diagnostic TRANSDUCERS 1. Disposable 2. Turbine 3. Fleisch ACCESSORIES STANDARD 4. Thermal paper 110x50 5. USB and printer cable connection 6. Nose clip 7. Plastic Mouthpiece 8. Disposable mouthpiece pack (25 u) 9. Disposable transducers pack (25 u) 10.
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Page 15: Spare Parts
DATOSPIR TOUCH User’s Manual 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 MEP-MIP module 07146 Sniff module FIRMWARE OPTIONS 07060 Bronchoconstriction module 07061 Concurrents display of V/t &... - Page 16 DATOSPIR TOUCH User’s Manual 03052 Shutter probe MEP-MIP 07147 Sniff probe (for MEP-MIP module) 05602 Adult MEP-MIP mouthpieces 01149 Paediatric Mouthpiece adapter 07221 Fleisch additional filter Included Optional Not included 511-B00-MU2 • REV. 1 .02...
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Page 17: Layout Of Controls And Connectors
DATOSPIR TOUCH User’s Manual 2.3 LAYOUT OF CONTROLS AND CONNECTORS FRONT PANNEL REAR PANNEL BASE Do not connect accessories not supplied by SIBEL,S.A. 1- Internal printer (thermal paper 9- Power supply connection roll). 10- USB connector for PC 2- Lever to lock/unlock the paper roll. 11- USB connector for external printer 3- ON /OFF button 12- Ethernet Connection... -
Page 18: 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 19 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 20 DATOSPIR TOUCH User’s Manual 2.4.2 RECHARGEABLE BATTERY: INSTALLATION AND LOAD The DATOSPIR TOUCH spirometer operates optionally with rechargeable Ni-Mh battery (10.8V 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.
- Page 21 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.
- Page 22 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 base of the spirometer and insert the bluetooth board where is shown in Figure.
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Page 23: 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 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 24 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 25 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 from the main screen, and then The options included in the CUSTOMIZATION MENU are:...
- Page 26 DATOSPIR TOUCH User’s Manual Set units: cm/Kg, in/lb, ºC/ºF or mmHg/hPa Main menu icons (enable/disable) Equipment Protection code (PIN) 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 Incentive for children and adults...
- Page 27 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 Interpretation: Select diagnosis according ATS/ERS, Miller, Snider/Kory/Lyons NLHEP.
- Page 28 DATOSPIR TOUCH User’s Manual 3.2.4 EQUIPMENT PROTECTION 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.
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Page 29: Internal Database
DATOSPIR TOUCH User’s Manual 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»... -
Page 30: Maintenance Program
DATOSPIR TOUCH User’s Manual MAINTENANCE PROGRAM The equipment 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. -
Page 31: Quality Control: Calibration Check
DATOSPIR TOUCH User’s Manual 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. Enter the new Activation code delivered by the After-sales service to enable the new option purchased. - Page 32 DATOSPIR TOUCH User’s Manual influence of the turbulence caused by the abrupt departure of the air: DISPOSABLE SYRINGE HOSE TRANSDUCER CALIBRATION ADAPTER CALIBRATION SYRINGE Power up the DATOSPIR TOUCH and press from the main menu. Discharge the syringe once at any range of the following flows varying between 0-12L/s: Low flow level: 0 - 1 L/s Mid-flow level: 2 - 5 L/s...
- Page 33 DATOSPIR TOUCH User’s Manual Press to cancel the maneuver or to 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: percentages variation calibration factors calculated as the average of all the maneuvers performed on a range flow.
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Page 34: Calibration Rocedure
DATOSPIR TOUCH User’s Manual menu, to require a daily calibration check CUSTOMIZATION before allowing access to any test. By default, this option is disabled. 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 35: Calibration Record
DATOSPIR TOUCH User’s Manual 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 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 36: 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 37 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 2 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 38 DATOSPIR TOUCH User’s Manual 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 to retrieve If patient already exists in the database, press the patient’s details from memory.
- Page 39 DATOSPIR TOUCH User’s Manual • 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 40 DATOSPIR TOUCH User’s Manual sum of FVC+FEV1 is considered the best. 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 41 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. •...
- Page 42 DATOSPIR TOUCH User’s Manual • Time audit: show the exact time of testing have been carried out 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.
- Page 43 DATOSPIR TOUCH 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 44 DATOSPIR TOUCH User’s Manual 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” option is activated. The report will include the parameters and graphs corresponding to the selected maneuver o 3 maneuvers.
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Page 45: Quality Of Fvc Tests
DATOSPIR TOUCH 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 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 46 DATOSPIR TOUCH User’s Manual - 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.
- Page 47 DATOSPIR TOUCH User’s Manual should take a break, depending on how the patient feels or stop measurement. 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? The patient must start exhaling...
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Page 48: Post Bronchialdilator Test
DATOSPIR TOUCH User’s Manual GRADE TEST CRITERIA At least 2 acceptable maneuvers with the largest 2 FEV values matching within 100mL VERY GOOD and the largest 2 FEV values matching better than 100mL. At least 2 acceptable maneuvers with FEV GOOD values matching between 101 and 150mL At least 2 acceptable maneuvers with FEV... - Page 49 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 •...
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Page 50: 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 51: 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 52: 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: 1. Transfer patient tests to a PC 2. Transfer Equipment Checking Data 3. Update Internal Software 4. -
Page 53: Transferring Equipment Check Data
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. • Hardware checkup •... -
Page 54: Adding Module, Options And/Or Transducer
DATOSPIR TOUCH User’s Manual 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 (SpO , MIP-MEP, bluetooth, weather... -
Page 55: Updating Firmware
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. - Page 56 DATOSPIR TOUCH User’s Manual The information is available in the following files: Contains the database tests PRUEBAS. CSV Contains the database patients PATIENTS.CSV Contains the graphs in Flow/Time mode GRAFxx. CSV The graph file, as indicated, contains the graphs for each test in Flow/Time mode.
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Page 57: 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 MES30A-3P1J power supplies • EMERSON DP4012N3M • DANUBE FRM030-S124 Medical device Class IIa classification... - Page 58 DATOSPIR TOUCH User’s Manual (EN ISO 10993.1: 2009 / AC: 2010) • Usability (EN 60601-1-6:2007) • Aptitude of use (EN 62366:2008) • Spirometers 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) •...
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Page 59: 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 CONSULT THE INSTRUCTIONS FOR USE PRECAUTION START-UP (STANDBY) BF APPLIED PART NO PHISIOLOGICAL PULSE OXIMETRY ALARMS IPX2 WASTE DISPOSAL ACCORDING THE WAEE DIRECTIVE SENSITIVE CONNECTOR TO ELECTROSTATIC DISCHARGES (See Annex 1) -
Page 60: 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 61 DATOSPIR TOUCH User’s Manual • FIV1/FIVC (%) Ratio • FEV1/FIV1 (%) Ratio • PIF (l/s) Inspiratory Flow Apex • MTT (s) Mean Transit Time • PEF/PIF (-) Ratio • Vext (%) Extrapolated Volume • MVVInd (l/min) Maximum Voluntary Ventilation (30 x FEV1) •...
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Page 62: 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 Region... -
Page 63: Transducers
DATOSPIR TOUCH User’s Manual 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 Dispos. Measurement Scale (BTPS) Flow 0 to ±16 l/s Volume 0 to 10 l Dynamic flow resistance <... -
Page 64: 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 65 DATOSPIR TOUCH User’s Manual B) TURBINE TRANSDUCER Remove the turbine from its housing by pressing slightly its tab so that is comes away from its fixtures. Wash the turbine with water and soap, avoiding solvents or abrasive substances that may damage the components.
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Page 66: Preventive Maintenance
DATOSPIR TOUCH User’s Manual thereafter the remanent humidity. Pay attention to avoid the introduction of strange elements in the pressure inlets of the Lilly handle. Do not use abrasive substances or solvents. 7.1.2. CLEANING THE SPIROMETER The spirometer should be cleaned gently with a cloth moistened with water and dishwasher detergent. -
Page 67: Corrective Maintenance
DATOSPIR TOUCH User’s Manual 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. -
Page 68: Annex 1. Electromagnetic Compatibility
DATOSPIR TOUCH User’s Manual Annex 1. ELECTROMAGNETIC COMPATIBILITY 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 symbol must be placed next to the Ethernet connector. - Page 69 DATOSPIR TOUCH User’s Manual 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 Complian Electromagnetic environment - Guidance...
- Page 70 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...
- Page 71 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 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.
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Page 72: Annex 2. Compliance With The Data Protection Act. Directive 95/46/Ec
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.
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