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Spirodoc

cod. 980156

Rev 1.3

EN 58/67

E

N

GLI

S

H

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. MED

– 9826

MIR srl Medical International Research, declares that the Device subject of this
declaration together with its standard accessories conforms to the requirements
of the Council Directive 93/42/EEC Annex I.

Device Description

Spirometer/Oximeter

Device Name

spirobank

II

Classification

IIa

This Device is marked

Any modifications to the Device which are not authorised by MIR will invalidate
this Declaration

Roma

01 / 01/ 2006

Paolo Sacco Bochetti
President of the Board of Trustees.

Rev.0

– Mod. PO-10DDC_

SPIRODOC

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Содержание Spirodoc

Страница 1: ...tery pack warning 11 2 5 Labels and symbols 14 2 5 1 Identification label 14 2 5 2 CE mark for medical devices 14 2 5 3 Electrical safety symbol 14 2 5 4 Warning symbol for the RS232 serial port 14 2...

Страница 2: ...gle Patient Sensor 49 4 datA TRANSMISSION 50 4 1 Data Transmission via Bluetooth to a cell phone 51 4 1 1 Preliminary Operations 51 4 1 2 Bluetooth data transmission 51 4 2 Data transmission via Bluet...

Страница 3: ...001 3 disposable turbines 910001 1 oximetry sensor 919010 Accessori COD Accessori COD Battery charger with micro USB connector 920680 Battery charger with micro USB connector 920680 Disposable adult o...

Страница 4: ...d or comments regarding this product may be sent via email to mir spirometry com MIR accepts no responsibility for any loss or damage caused by the user of the device due to instructions contained in...

Страница 5: ...C has been designed for use in the doctor s office in a hospital or directly by the patient to continuously monitor her his physical conditions during routine daily activities All information necessar...

Страница 6: ...before a spirometry test is made The user is responsible to assess both the mental and the physical condition of the patient in order to perform a proper test furthermore in the evaluation of test res...

Страница 7: ...thium battery pack In normal conditions the lifespan of the battery pack is estimated to be around 10 years The device constantly monitors the state of charge of this battery and a message informs the...

Страница 8: ...ce 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 3 Mouthpiece Any disposable mouthpieces include...

Страница 9: ...sensors supplied with or specifically intended for use with SPIRODOC Use of oximetry sensors not intended for use with the SPIRODOC may cause inaccurate readings Oximetry measurements may be inaccurat...

Страница 10: ...h as a TV radio portable phone etc and other electronic units are operated at the same time in the same room The device may give inaccurate readings if operated in the presence of strong electromagnet...

Страница 11: ...lied with the device which delivers 3 7 volts For proper use of the battery pack please read carefully the warning below WARNING Do not use the battery pack for any purposes different from those speci...

Страница 12: ...fire Do not use or store the battery near a fire or if the temperature inside a vehicle may reach 60 C or become higher Do not immerge the battery pack in water or salt water and do not leave it wet S...

Страница 13: ...ore using the battery pack carefully read the manual paying attention to all the recommendations for proper handling For information concerning the installation and removal of the battery pack careful...

Страница 14: ...duct is certified to conform to the Class II requirements of the 93 42 EEC medical device directive 2 5 3 Electrical safety symbol In accordance with the IEC 60601 1 Standard this product and its comp...

Страница 15: ...following conditions 1 this device must not cause harmful interference 2 this device must accept any interference received including interference that may cause undesired operation Any modifications n...

Страница 16: ...rement device intended for use by a respiratory specialist or by a suitably trained general practitioner The spirometer calculates up to 30 functional respiratory parameters providing the pharmacodyna...

Страница 17: ...ivo utilizzando la connessione Bluetooth al PC del medico Pertanto il medico pu valutare a distanza i parametri legati alla patologia del paziente SPIRODOC can also be connected to a PC or to another...

Страница 18: ...test L FEV1 FVC FEV1 FVC x 100 FEV1 VC FEV1 best between EVC and IVC x 100 PEF Peak expiratory flow L s FEF2575 Average flow between 25 and 75 of the FVC L s FEF25 Forced Expiratory Flow at 25 of FVC...

Страница 19: ...try SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 Average in first three minutes SpO2 Min SpO2 Minimum during period of analysis SpO2 Max SpO2 Maximum during period of analysis SpO2 Mean SpO2 Average du...

Страница 20: ...above 5 minutes hh mm ss NOD 90 Time passed with SpO2 90 for continued periods above 5 minutes with minimum value 86 Nadir hh mm ss DELTA Parameters measured for six minute walk test analysis SYMBOL...

Страница 21: ...rea under SpO2 curve base relative to distance covered Dyspnea Borg CHG Variation in grade of dyspnea during walking Fatigue Borg CHG Variations in level of fatigue during walking DELTA There follows...

Страница 22: ...frared absorption Range of measurement SpO2 0 100 with 1 increments SpO2 Resolution 1 SpO2 accuracy 2 between 70 100 SpO2 Average number of heart beats for the SpO2 calculation 8 beats Range of measur...

Страница 23: ...l protection BF Grade of protection against water ingress IPX1 device protected against water drops Safety level in the presence of inflammable anaesthetic gas oxygen or nitrogen Device not suitable C...

Страница 24: ...access the default settings service menu To access patient data from the main display To perform a new test of a patient recalled from the patient records To insert new patient data To modify patient...

Страница 25: ...on after approximately 10 seconds of disuse the display enters energy saving mode thereby lowering the display contrast level automatically If the device remains in disuse for approximately 5 minutes...

Страница 26: ...Date Time Date Format Unit Format Turbine selection Standards setting LCD setting BLUETOOTH setting Firmware information Oximetry alarms SpO2 sampling rate Spirodoc mode Parameter settings Menu type S...

Страница 27: ...rom left to right 1 2 2 3 3 3 If an error occured during insertion of the password the following message will appear Password Error Press OK and try again If you fail to insert the password again the...

Страница 28: ...HANES III The selection will be saved automatically and the device will return to the service menu LCD setting This menu allows for Setting of display luminance and contrast Two scales ranging from 0...

Страница 29: ...onents 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...

Страница 30: ...plified mode the user can only view the main parameters as per actual standards The personalized mode allows to select the parameters of interest The complete mode allows to view all the parameters th...

Страница 31: ...rd To access the service menu select the item Inser password and enter the following password 1 2 2 3 3 3 In this mode the service menu displays the following items Spirodoc mode Personal best Turbine...

Страница 32: ...e chosen by the patient Domanda Possibili risposte Tiredness on waking NO MED MAX Daytime drowsiness NO MED MAX Breathless on waking NO MED MAX Troubled sleep NO MED MAX Wheezing NO MED MAX Cough NO M...

Страница 33: ...these are displayed next to the New FVC and New FIVC parameters The message ENTER OK TO CONFIRM will appear By touching the ESC icon the device will automatically return to the service menu without a...

Страница 34: ...ibrated correctly then the FVC syringe value will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS If the ambient temperature is 20 C the FIVC syringe value will be 3 00 FIVC x 1 102 BTPS 3 31 L FIVC at BT...

Страница 35: ...n Oriental 100 Afro American Hong Kong Chinese 100 Other Giapanese 89 polinesian 90 North Indian 90 South Indian 87 Pakistani 90 African descendant 87 For ATS ERS standards the correction is applied t...

Страница 36: ...ouch the OK icon The data returned by the device are all the test sessions performed during that specific day Complete database shows data starting from the most recent session The end of the database...

Страница 37: ...sage EMPTY LIST Device search Touch OK to confirm By touching the OK icon the device will search for any nearby devices if any devices are found these can be memorized in the specific Bluetooth list 3...

Страница 38: ...er to perform proper spirometry testing the following instructions are to be followed carefully Insert the turbine in the appropriate housing until it reaches the mechanic stop and successively rotate...

Страница 39: ...nspiratory parameters FIVC FIV1 FIV1 PIF are not of interest The optional initial inspiration phase can also be performed before inserting the mouthpiece in the mouth After inspiring slowly and deeply...

Страница 40: ...iratory Slow Vital Capacity VC After the acoustic signal inspire slowly as much as air as possible and expire slowly as much air as possible Inspiratory Slow Vital Capacity IVC After the acoustic sign...

Страница 41: ...sion a new patient is inserted or another is recalled from the archive the device will automatically exit the current POST session 3 12 Viewing the spirometric results Following a FVC test the spirome...

Страница 42: ...more than one but the FEV1 values not matching to within 200 mL with no interpretation F No acceptable manoeuvres with no interpretation POST test A two acceptable 1 FEV1 values matching within 100 m...

Страница 43: ...RNING If SPIRODOC has been purchased without the oximetry option only spirometry testing can be performed If the oximetry option is purchased afterwards please contact a service center or the manufact...

Страница 44: ...probe Ensure that the bottom part of the finger completely covers the detector If the finger cannot be placed properly inside the sensor try another finger Position the sensor so that the cable is und...

Страница 45: ...itself and the device starts recording data For any type of oximetry test if the sensor is not properly connected the following message will be displayed on screen after a few seconds WARNING Sensor n...

Страница 46: ...formation concerning the proper setup of this function please refer to paragraph 3 6 WARNING A test is saved with the name of the last patient displayed If a test refers to a previously saved patient...

Страница 47: ...the timer is reset to zero so that the user can immediately see of the duration of each single phase The data on the display is the same as shown before This stage will continue for a minimum of 2 min...

Страница 48: ...calculated during the initial stage of the test 3 13 2 Sleep Oximetry To access the oximetry area from the main screen touch the icon next select the icon to select the test This test records overnigh...

Страница 49: ...refer to paragraph 4 2 for a data printout an example can be found in the attachments inside this user manual 3 13 4 Instructions for Adult Single Patient Sensor WARNING The oximetry sensor used in t...

Страница 50: ...ector Wrap the adhesive around the finger or toe to secure the sensor Route the cable along the palm or the bottom of the foot and secure with adhesive tape if necessary Connect the sensor to the devi...

Страница 51: ...n on the SPIRODOC Touch the icon on the main screen The type of transmission selected is shown if this is correct then confirm with OK to activate the connection to the default device that was initial...

Страница 52: ...est of interest was performed Upon entering the test session select the test and touch the icon If no device was setup to print via Bluetooth a message will appear on screen which allows the device to...

Страница 53: ...matic driver installation for Windows 98 2000 ME or request some information for Windows XP Vista and Seven To avoid making any errors at this stage please read the Advanced section of the winspiroPRO...

Страница 54: ...advantage of requiring no periodic calibration In order to maintain the default characteristics of the reusable turbine a simple cleaning procedure is required before use Cleaning of the disposable tu...

Страница 55: ...s housing making sure to turn it clockwise as shown by the symbol of the lock printed on SPIRODOC The turbine is inserted properly by pushing it all the way in and subsequently rotating it clockwise u...

Страница 56: ...on SPIRODOC and the following icon will appear on the main screen showing the charge level of the battery pack The maximum charge level is displayed with all 6 bars inside the battery If only one bar...

Страница 57: ...evice 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 a...

Страница 58: ...No 0476 Certificate No MED 9826 MIR srl Medical International Research declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the C...

Страница 59: ...oes not conform to the current safety norms in the country of installation If the product is utilised differently from the use described in the User s Manual If any alteration adjustment modification...

Страница 60: ...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 ALLEGATO 1 O...

Страница 61: ...Spirodoc cod 980156 Rev 1 3 EN 61 67 ENGLISH...

Страница 62: ...Spirodoc cod 980156 Rev 1 3 EN 62 67 ENGLISH...

Страница 63: ...Spirodoc cod 980156 Rev 1 3 EN 63 67 ENGLISH ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE...

Страница 64: ...ser of the Spirobank II should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The SPIRODOC uses RF energy on...

Страница 65: ...mmon mode Not Applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 6100...

Страница 66: ...res objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broa...

Страница 67: ...smitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 P 3 80 MHz to 800 MHz d 3 5 P 3 800 MHz to 2 5 GHz d 7 P 3 0 01 0 12 0 24 0 24 0 1 0 37 0 37 0 74 1 1 17 1...

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