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MIROxi

User Manual cod. 980265

Rev 1.6

Page 1 of 32

MIROxi

User Manual

User Manual Rev. 1.6

Issued on: 06/10/2008

Approved on: 06/10/2008

Содержание MIROxi

Страница 1: ...MIROxi User Manual cod 980265 Rev 1 6 Page 1 of 32 MIROxi User Manual User Manual Rev 1 6 Issued on 06 10 2008 Approved on 06 10 2008...

Страница 2: ...hardware will be recognised by the PC The device can then be used with the winspiroPRO software Keep the original packaging In the event that your device requires service then always use the original...

Страница 3: ...evel 13 2 3 Information 13 2 4 Initial Set up 13 2 5 Patient Data 15 2 6 Displaying data in memory 16 2 7 Online operating mode connected to a PC 16 2 8 Oximetry testing 16 2 8 1 Walk Test 6MWT 18 2 8...

Страница 4: ...her own health The procedures for using the device at home are described according to the type of test to be made the display will show all instructions messages suggestions etc step by step which all...

Страница 5: ...tery is discharged Contact Technical Service to have this battery changed In the event of any incident or accident of any kind resulting from the use of the device the user is required to inform the m...

Страница 6: ...manufacturer Never attempt to make a repair oneself The set up of configurable parameters should only be made by qualified personnel However an incorrect set up of the parameters does not put the pati...

Страница 7: ...1 4 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 1 4 3 Electrical safety symbol In accordance with the...

Страница 8: ...his equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by...

Страница 9: ...BPM hh mm ss T 120 BPM Time passed with pulse frequency 120 BPM hh mm ss N Events 40 BPM Bradycardia events during the entire period of analysis N Events 120 BPM Tachycardia events during the entire a...

Страница 10: ...f the method for calculating the area below the SpO2 baseline curve Parameters requested for six minute walk test analysis SYMBOL DESCRIPTION Units Dyspnea Borg Baseline Grade of dyspnea before walkin...

Страница 11: ...brane keyboard with 6 keys Interface RS232 USB Bluetooth Duration of the CR2032 3V lithium battery memory backup Circa 10 years under normal conditions of use and storage Power supply 4 x AAA batterie...

Страница 12: ...et up Service Menu To manage or enter new patient data from the main screen To enter new patient data To modify patient data To carry out an oximetry test To access previous tests To access transmissi...

Страница 13: ...i x y device name and software revision number Power means USB or battery symbol Current date and time icon Access to the Service Menu SpO2 BPM icon Press OK to go to the second display Press ESC to g...

Страница 14: ...Oxi will start to search for Bluetooth devices in the area once one or more devices are found the screen will display profiles press OK to set the device as printer or phone select one of the two opti...

Страница 15: ...y To enter new patient data From the Patient Data Management menu press to access the data input screen First screen name and surname Use and to select required letters confirm or delete using or To i...

Страница 16: ...ut searching Use from the data screen icon to print out data through a Bluetooth connection automatic use to display all test data of relevant file on memory use and to scroll through data press OK to...

Страница 17: ...DESCRIPTION Walk test 6MWT Sleep oximetry Oximetry SpO2 BPM WARNING In order not to compromise the reproducibility of the measurements and the integrity of the sensor avoid twisting the sensor cable...

Страница 18: ...o pass to the following walking phase The number of bars I symbol on the right upper of the screen is proportional to the quality of the oximetry signal the higher the quality of the signal the more b...

Страница 19: ...i will go on standby i e it stops beeping and the display turns off The led signal remains on To control the correct functioning while on standby press then after 1 minute MIROxi will return to standb...

Страница 20: ...se of this sensor is indicated for patients weighing more than 30 Kg and contraindicated for patients with allergy to adhesive tape WARNING The materials used for manufacturing the sensor are NATURAL...

Страница 21: ...rious tests to the doctor s PC follow this procedure Dial the doctor s phone number for example the doctor s office telemedicine services or any other structure directly on the telephone in use Place...

Страница 22: ...or s office telemedicine service etc To enter the telephone number see the main menu when the machine is turned on Refer to Paragraph 2 4 A device must also be set up for the connection refer to Parag...

Страница 23: ...ortant prior to initiating the following procedure to know the version of the operating system installed on the PC used for the connection from control panel click on System where the type of operatin...

Страница 24: ...nsor 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 Push the sensor to insert the pins into the holes of t...

Страница 25: ...of oximetry testing the test data is incorrect Clean the sensor and then control it otherwise use a new one All data in memory lost due to an unforeseeable event All data in memory has been deleted Co...

Страница 26: ...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...

Страница 27: ...utilised differently from the use described in the User s Manual If any alteration adjustment modification or repair has been carried out by personnel not authorised by the manufacturer If the fault...

Страница 28: ...MIROxi User Manual cod 980265 Rev 1 6 Page 28 of 32 ANNEX 1 OXYMETRY TEST REPORT EXAMPLES...

Страница 29: ...MIROxi User Manual cod 980265 Rev 1 6 Page 29 of 32...

Страница 30: ...MIROxi User Manual cod 980265 Rev 1 6 Page 30 of 32 MIROxi...

Страница 31: ...4 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not Applicable Mains power...

Страница 32: ...een portable and mobile RF communications equipment and the MIROxi The MIROxi is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the...

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