ENGLISH Spirodoc User Manual Rev. 1.3 Issued on Approved on 27/04/2010 27/04/2010 INDEX 1. 2. EQUIPMENT AND ACCESORY LIST ................................................................ 3 INTRODUction ................................................................................................... 4 2.1 Intended use ................................................................................................ 4 2.1.1 User category ....................................................................
Spirodoc cod. 980156 Rev 1.3 EN 2/67 ENGLISH 3.7.2 Patient data modification ....................................................................... 35 3.8 Visualization of memory data..................................................................... 36 3.8.1 Database research modality .................................................................. 36 3.8.2 Visualization of database info ................................................................ 36 3.
EQUIPMENT AND ACCESORY LIST ENGLISH 1. Thank you for choosing a MIR product MEDICAL INTERNATIONAL RESEARCH The original packaging of the product contains one of the following spirometers with the following accessories: spirometer configuration Accesssories sold with COD.
Should this be the case, please follow these guidelines: Return the complete device in the original packaging. Shipping costs any any customs duties must be paid by the sender. Manufacturer‟s address: MIR SRL VIA DEL MAGGIOLINO, 125 00155 ROME (ITALY) Tel ++ 39 0622754777 Fax ++ 39 0622754785 Web site: www.spirometry.com Email: mir@spirometry.com MIR has a policy of continuous product development and improvement.
User category SPIRODOC spirometer + oximeter calculates a series of parameters relating to human respiratory function. Typically the doctor “prescribes” a spirometry test and is responsible for analysing and checking the results obtained. 2.1.2 Ability and experience required The correct use of the device, the interpretation of the results and the maintenance of the device all require qualified personnel.
Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results. 2.1.4 Who can or must make the installation The device requires installation by qualified personnel. The doctor will configure the device before handing it over to the patient for homecare use. 2.1.5 Patient effect on the use of the device A spirometry test should only be carried out when the patient is at rest and in good health, in suitable testing conditions.
WARNING The safety and the correct performance of the device can only be assured if the user respects all of the relevant safety rules and regulations. The manufacturer will not be held responsible for damage due to user’s neglect to correctly to follow these instructions. The device must be used only and exclusively as a spirometer following the indications given by the manufacturer with particular attention to the paragraph on INTENDED USE, and utilizing only original spare parts and accessories.
The following information applies to both turbine models. The turbine must never be held under running water or direct air pressure and must never come into contact with hot fluids. Do not allow dust or foreign bodies to enter the turbine sensor which may alter the correct functioning and possibly cause damage. The presence of any impurities such as hair, sputum, threads etc. within the body of the turbine sensor may seriously compromise the accuracy of the measurements. 2.2.
3043 3078 3178 3444 3044 universal Y sensor ear sensor pediatric finger sensor, reusable adult sensor reusable (Comfort Clip) adult finger sensor, reusable ENGLISH BCI BCI BCI BCI BCI These sensors require the use of an extension cable (product code 919200) for a proper connection to the device. The same sensors are also available with a microconnector for a direct connection. Prolonged use and/or the patient‟s condition may require changing the sensor site periodically.
Autoclaving, ethylene oxide sterilizing, may cause sensor damage. Do not attempt to sterilize the sensor. Unplug the sensor from spirodoc before cleaning or disinfecting to prevent damaging sensor or device, and to prevent safety hazards for the user. 2.2.5 Device WARNING The maintenance operations detailed in this manual must be fully and accurately carried out. If these instructions are not followed this may cause measurement errors and/or an incorrect test interpretation.
Unforeseen errors In case device internal memory data is damaged, when the device is switched on, the following message appears: Error on RAM memory Recovery data Please wait If data has been successfully recovered, the device completes the standard turn on procedure, otherwise please contact an authorized technical assistance center or the manufacturer. In case of a problem with the device, a message indicating the nature of the problem will appear on the screen, together with a warning “beep”.
During battery pack use Recharge the battery pack with a specifically designated battery charger and observe the charging procedure as specified by the manufacturer. Recharging without adhering to proper recharging conditions may cause the battery to overcharge at extremely high voltage. Various abnormal chemical reactions may occur such as acid leakage, overheating of the battery, smoke emission, breakage and fire. The battery pack may be used within a temperature range from −20°C e to approximately 60°C.
Do not in any way disassemble or modify the battery-pack; the battery pack comes with an internal safety protector, which if tampered with may cause acid leakage, overheating, smoke, breakage and/or fire. Do not solder the battery pack. Do not use a heavily scratched or deformed battery back as this may be cause for acid leakage, overheating, smoke, breakage and/or fire.
2.5 Labels and symbols 2.5.1 Identification label The label shows: Serial number of the device Product name Name and address of the manufacturer Electrical safety symbol CE mark in compliance with the Directive 93/42 EEC. WEEE symbol 2.5.2 CE mark for medical devices 0476 This product is certified to conform to the Class II requirements of the 93/42/EEC medical device directive. 2.5.
2.5.6 Warning symbol for the SpO2 port for oximetry SpO2 2.5.7 Warning symbol for the WEEE As laid down in the European Directive 2002/96/EEC requirements regarding the disposal of electrical and electronic devices (WEEE), at the end of its useful life this device must not be thrown away together with normal domestic waste as it contains materials which would cause damage to the environment and/or represent a health risk.
2.5.9 ENGLISH Labels and symbols are displayed on the device as shown in the following images: Product description SPIRODOC…. is a pocket spirometer, with an optional pulse oximetry module. It can operate either in stand alone mode or it can be connected to a PC or to a printer using any one of several methods: RS232, USB, Bluetooth. Spirodoc… is specifically designed to measure a range of respiratory parameters and to monitor the saturation of oxygen in the blood and the heart beat.
ENGLISH REUSABLE TURBINE DISPOSABLE TURBINE The following precautions must be observed to ensure that the characteristics of the turbine remain unaltered over time: for the disposable turbine: must always be substituted from one patient to the other. for the reusable turbine: always clean the turbine between patients, to ensure the maximum level of hygiene and safety of the patient.
2.6 Technical specifications A comprehensive description of the main features of the device, the flow and volume measurement turbine and also of the oximetry sensor follows: 2.6.
Average flow of inspiration, at rest tE/(tI+tE) Maximum voluntary ventilation Estimated lung age L/min \ L/min year *= best values Flow/volume measurement system Temperature sensor Measurement principle Volume range Flow range Volume accuracy Flow accuracy Dynamic resistance at 12 L/s 2.6.2 Bi-directional digital turbine semiconductor (0-45°C) Infrared interruption 10 L 16 L/s 3% or 50 mL 5% or 200 mL/s <0.
\ ENGLISH N° Events > 120 Tachycardia events during the entire period of BPM analysis Desaturation events during the entire period of Tot. Desat.
Recording time Baseline Time Walking Time Tachycardia events during the entire period of analysis Total time measure of SpO2 Duration of baseline phase Duration of walking phase Time for SpO2 value 99% of the average \ hh:mm:ss hh:mm:ss hh:mm:ss Recovery Time base value calculated during the initial phase hh:mm:ss of the test. Predicted Pred.
Average pulse frequency in the first 3 minutes Minimum pulse frequency during the period of BPM Min analysis Maximum pulse frequency during the period of BPM Max analysis Average pulse frequency during the period of BPM Mean analysis Recording time Total time measure of SpO2 T < 90% Time passed with SpO2 < 90 % T < 89% Time passed with SpO2 < 89 % T < 88% Time passed with SpO2 < 88 % T < 87% Time passed with SpO2 < 87 % N° Events SpO2 < Fall of SpO2 below 89 % for at least 20 seconds 89% Index of SpO2 fluct
Other features Memory Display Keyboard Interface Duration of the CR2032 3V lithium battery (memory backup) Power supply Dimensions Weight Type of electrical protection Type of electrical protection Grade of protection against water ingress Safety level in the presence of inflammable anaesthetic gas, oxygen or nitrogen Conditions of use Storage conditions Operating conditions Applied norms 3.
3.2 ENGLISH To visualize the list of information flick through the left part of the screen. Accensione e spegnimento di SPIRODOC To turn on the SPIRODOC press and release the key placed in the middle on the side of the device. To turn off the SPIRODOC press the same key for at least two seconds. 3.
To perform a sleep oximetry test To perform a 6MWT/ to move on to the walking phase of the test Tom move on to the recovery phase of the 6MWT To access spirometry testing type to perform a forced vital capacity test FVC To perform a slow vital capacity spirometry test VC To perform a maximum voluntary ventilation spimetry test MVV To perform a spirometry test with a broncodilator To print via Bluetooth connection 3.
3.
Adults ERS Knudson USA ERS MC-Barcelona ENGLISH Selection of the Predicted values Select the option by touching the display. A list of Predicted values is visualized; select the desired Predicted value. Pediatric Knudson Knudson Knudson Zapletal Zapletal Select the pair of Predicted values; automatically the desired predicted values are set and the device will return to the service menu. WARNING If the NAHNES III standard is chosen the Predicted values cannot be set or modified.
month day month ENGLISH day month year year year day Select the desired format; this will be set automatically and the device will return to the service menu. Unit format Select the option by touching the display. Imperial Metric (in,lb) (cm kg) Scegliere la modalità desiderata; automaticamente questa viene impostata ed il dispositivo torna al menu di servizio. Turbine selection Select the option by touching the display. Select the type of turbine to be used (reusable or disposable).
Firmware Information The user can access the menu to view information of the version control of the following components: Spirodoc Bluetooth After approximately 10 seconds the device automatically displays the Service Menu, otherwise press . Oximetry Alarms Access to this function allows the setup of reference values for SpO2 and BPM; an acoustic alarm will warn the user if the SpO2 and BPM during a test fall below the minimum or rise above the maximum set reference SpO2 and BPM values.
Personal mode Doctor mode Personal mode is set by the doctor when the device will be used by the patient for home care use; for health condition screening. Doctor mode enables full use of the device for expert use. By touching the desired mode the device is set and automatically returns to the service menu. Parameter Settings Three different types of parameter calculations can be selected for spirometry and oximetry testing.
Patient Mode This mode allows to simplify the use of the device for a patient during the day and lets the doctor setup various functions useful to assess the patient‟s state of health as it evolves in time. In patient mode the main screen appears as follows.
Personal best value setup Use predicted source Questions Setup Specific questions can be written so that when the patient turns-on the device a table will be displayed with a series of questions. The following table displays the items which can be selected and the response options which can be used by the patient. A multiple selection can also be implemented.
BTPS 300 300 000 ◄ %Corr. 0.00 0.00 ENGLISH VOL. 300 Ultima FVC UltimaFIVC Nuova FVC Nuova FIVC FVC=0 CALIBR. DI FABBRICA The Old FVC and the Old FIVC values shown are those values from the last calibration performed. The values under the %Corr. column indicate the correction factor. These are pre-set or 0 by default. To perform a calibration: 1 - Insert the volume in cL of the calibration syringe in use (e.g. for a 3L syringe, insert 300 cL).
3.7 Patient Data From the main screen the user can access the patient data management by using the icon . . By entering in the menu it is possible to: Modify the current patient data Create a new patient 3.7.1 Inserting data of a new patient Touch the icon and insert the patient information in the required sequence. First screen (name) Write the name of the patient with the touchscreen keyboard.
Male Female To move from one item to the next touch the OK icon.
ENGLISH 3.8 Visualization of memory data 3.8.1 Database research modality From the main screen it is possible to access the database of the device by using the icon. Four methods of research are available: Reseach by patient date of birth. Research by the date of testing. Visual of all tests in the database starting form the most recent. Research by patient sirname. Research by patient date of birth: patient date of birth must be inserted; after all the data has been inserted touch the OK icon.
ENGLISH Once a testing session has been selected the database screen will show the adjacent image. By scrolling the screen as in paragraph 3.1 the user may select the desired test of a session. The three icons on the lower part of the screen allow access to the following functions: To perform a new testing session with the selected patient. To send via Bluetooth to a printer the parameters of a selected test. To view the parameters of a selected test.
Other than the usual spirometric parameters and the F/V in real-time the Spirodoc also plots the most refined indices such as the ventilatory profile and the extrapolated volume (Vext). The PC software incorporates the most up to date bronchial provocation protocols displaying the dose-response and time-response of the FEV1 WARNING When the device is connected to the PC it cannot be remotely controlled from the device itself.
test with broncodilator Once a test is selected the screen will display information concerning the type of turbine in use (reusable or disposable) including the necessary info to complete the test in the correct manner. WARNING A test is saved with the name of the last patient displayed. If a test refers to a previously saved patient, then prior to performing a test the user must recall that patient from the database as described in paragraph 3.8.2 3.11.
Six seconds from the start of the forced expiratory test, the Spirodoc emits a continuous beep. This is useful for the doctor to understand if the patient has reached the minimum expiry time, as per the requirements of the major international pneumology associations. 3.11.2 Test VC Ventilatory Profile The slow vital capacity test can be started by carrying out several breaths at tidal volume.
Simplified menu To access the spirometry area touch the subsequently touch the icon on the main screen and icon. A “POST” test refers to a spirometry test after having administered to a patient a pharmacological bronchodilation protocol. Before carrying out the test is is necessary to indicate the drug dosage administered as a reference when checking the results of the measured parameters.
Through the use of a mathematical analysis applied to certain indices and parameters calculated in the FVC test , the SPIRODOC is capable of producing a list of quality control comments useful to assess the quality and reproducibility of the manouvers performed.
Blow out all air in lungs Between tests, the SPIRODOC checks the repeatability of the following parameters: PEF repeatable when the difference between the two largest PEF is ≤ 0.67 L/s; VC repeatable when the difference between the two largest VC ≤ 150 mL; If FVC is > 1.0 L then: FEV1 repeatable when the difference between the two largest FEV1 is ≤ 150 mL; FVC repeatable when the difference between the two largest FVC is ≤ 150 mL; if FVC is ≤ 1.
For the non-invasive measurement of SpO2 oxygen saturation and blood pulse rate, utilize the re-usable finger sensor. This sensor is recommended for patients weighing more than 20 Kg while remaining still during testing. For the 6 minute walk test other types of sensors are recommended which are less influenced by the movement of the hand.
Low battery level Touch the ESC icon to exit the test, otherwise after a seconds will start the test. In the event that a test is interrupted due to a complete battery discharge, the next time the device is turned on the following message is displayed: WARNING Wrong interruption of last oximetry test At the same time an intermittent beep is emitted for ten seconds. Subsequently the SPIRODOC returns to the main screen.
ENGLISH If the alarms are activated during oximetry testing the icon will always show up on screen. The alarms function can be activated/deactivated even during oximetry testing. By touching the icon the screen on the right-hand side will appear which allows to check the threshold values; to activate/deactivate the alarms function simply touch the ON or OFF icons. If the screen remains untouched for a few seconds the device will return to the screen of the oximetry test in progress.
walking recovery ENGLISH Initial Rest In this stage the display will show the following data: Test time duration Signal quality indication Current stage SPO2 percentage value and the cardiac pulse rate (heart symbol) The “initial rest” stage must continue for a minimum of 2 minutes, after which the icon will appear on screen. Simply touch the icon to move on the next “walking” stage.
SEVERITY None Very Very Slight (Just Noticeable) Very Slight Slight Moderate Some What Severe Severe “ Very Severe “ Very Very Severe (Almost Maximum) Maximum ENGLISH SCALE 0 0.5 1 2 3 4 5 6 7 8 9 10 All the data from the walk test can be viewed in the following 6 screen shots and can also be printed by following the instructions found in paragraph 4.2.
ENGLISH 3.13.3 Oximetry SpO2/BPM To access the oximetry area form the main screen touch the icon, next select the icon. The test duration is unlimited and the aim is to record variations of the oximetry values during a length of time decided by the doctor. During the test the display shows the information that appears in the image to the right. The BEEP and ALARM icons allow to modify the following settings: BEEP, allows to activate/deactivate the heart beat acoustic signal during the test.
ENGLISH Choose an application site on the patient‟s finger or toe where the light source will be directly over and in-line with the detector. The preferred sites are the forefinger or smaller thumb. Remove nail polish or artificial fingernails. Insert the patient‟s digit in the sensor nail-side up, lining up the digit‟s pad over the detector. The sensor‟s positioning line runs across the mid axis of the fingertip Wrap the bottom adhesive around the digit, being careful not to cover the nail.
4.1 Data Transmission via Bluetooth to a cell phone SPIRODOC incorporates a “Bluetooth” wireless data transmission system. This radio wave connection allows SPIRODOC to connect to a suitable mobile phone. All the data in SPIRODOC can be transferred with this method of data transmission. The step by step procedure is described below. 4.1.
4.2 ENGLISH Should there be any errors during the data transfer the message on the right will appear on screen. The device will automatically return to the main screen; repeat the procedure again. Data transmission via Bluetooth for printing WARNING Data printing from the patient management function will only work if the printer too has a Bluetooth connection; another possible solution is with the use of a USB adaptor installed on the printer, thus enabling a Bluetooth connection.
Before connecting the SPIRODOC via USB to the PC, the WinspiroPRO software must be installed on the PC first to enable the software to interface with the device. Before initiating the following procedure it is important to know the operating system version installed on the PC used for the connection (from control panel click on “System”, where the type of operating system installed on the PC can be checked). If winspiroPRO is already installed on the PC then a new installation is not required.
ENGLISH SPIRODOC requires very little maintenance The operations to perform periodically are: Cleaning and checking the reusable turbine. Changing the disposable turbine before each test. Cleaning the oximetry sensor (for reusable sensors). Changing the adhesive tape of the oximetry wrap sensor. Changing the battery. The maintenance operations described in the User‟s Manual must be carried out with extreme care.
Do not place the turbine under a direct water jet or other liquid. If no detergent solution is available, clean the turbine in clean water. MIR suggests the use of Perasafe, manufactured by Dupont, which has been tested on all MIR sensors. Rinse the turbine by immerging it in clean water (not hot). Shake off the excess water from the turbine and let it dry, position the turbine vertically on a dry surface.
ENGLISH WARNING Do not sterilize by irradiation, steam or by using ethylene oxide. Unplug the sensor from the device before cleaning or disinfecting it. 5.3 Changing the adhesive wrap sensor The adhesive tape is made with latex-free material. Gently remove the used adhesive tape from the sensor and dispose of it. The back of the sensor has alignment pins. Place the sensor with the alignment pins facing the adhesive part of the tape and align the pins to the holes on the tape.
While in use the device turns off and on again. - An internal error has occured, please check on the website www.spirometry.com for new internal software upgrades. Should there be a newer internal software version please upgrade the device by using the winspiroPRO software. For further information please refer to the winspiroPRO user manual available inside the software itself. At the end of a spirometry test the data measurements are not reliable. - Clean the turbine as shown in paragraph 5.
ENGLISH srl MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125, 00155 Roma - ITALY Declaration of CE Conformity Quality Management System according to the requirements of Annex II of the Medical Device Directive 93/42/EEC implemented by the Legislative Decree 46 dated 24/02/97 Notified Body CERMET No. 0476 - Certificate No.
spirobank II, together with its standard accessories is guaranteed for a period of: 12 months if intended for professional use (doctors, hospitals, etc.) 24 months if the product has been purchased directly by the end user. The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase. The warranty is effective from date of sale which must be shown on the relevant sales invoice or proof of purchase.
ALLEGATO 1 Spirodoc OXIMETRY TEST REPORTS EXAMPLES cod. 980156 Rev 1.3 EN 60/67 ENGLISH MIR – Medical International Research reserves the right to modify the device if required, and a description of any modification made will be sent along with the returned goods.
ENGLISH Spirodoc cod. 980156 Rev 1.
ENGLISH Spirodoc cod. 980156 Rev 1.
Spirodoc ENGLISH ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE cod. 980156 Rev 1.
CORRECT USE IN AN Guidance and manufacturer’s declaration – electromagnetic emissions The spirobank II is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirobank II should assure that it is used in such an environment.
The spirobank II is intended for use in the electromagnetic environment specified below. The customer or the user of the spirobank II should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment – test level guidance Electrostatic Floors should be wood, concrete or ceramic 6 kV contact 6 kV contact discharge (ESD) tile.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE UT is the a.c. mains voltage prior to application of the test level. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
The spirobank II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the spirobank II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the spirobank II as recommended below, according to the maximum output power of the communications equipment.