BIOCORP Mallya Скачать руководство пользователя страница 1

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10-2020

IFU_MAL_EN_V6

Instructions For Use

Designed for Flexpen

Novo

Nordisk

Designed for Kwikpen

Eli Lilly

Designed for Solostar

Sanofi

Embedded software version 3.7.

Helping you keep track of your insulin doses

Содержание Mallya

Страница 1: ...0 IFU_MAL_EN_V6 Instructions For Use Designed for Flexpen Novo Nordisk Designed for Kwikpen Eli Lilly Designed for Solostar Sanofi Embedded software version 3 7 Helping you keep track of your insulin...

Страница 2: ...YOUR MALLYA 10 5 2 1 CHARGING YOUR MALLYA 10 5 2 2 CALIBRATING YOUR MALLYA 11 5 3 ASSEMBLING YOUR MALLYA TO THE INSULIN PEN 12 5 3 1 ATTACHING BASE TO PEN 12 5 3 2 ATTACHING BUTTON TO PEN 12 5 4 PAIR...

Страница 3: ...IST TABLE 1 SYMBOLS USED IN IFU 4 TABLE 2 ABREVIATIONS LIST 4 TABLE 3 MALLYA COMPATIBILITIES MOLECULES AND CONCENTRATIONS 2 TABLE 4 MALLYA PARTS NUMBERS 3 TABLE 5 PARTS NECESSARY FOR OPERATION 4 TABLE...

Страница 4: ...injury means electrical shock or poisoning that causes a subsequent complication or requires hospitalization or long term outpatient treatment 2 Bodily injury means an injury burn electrical shock and...

Страница 5: ...sage environment The Mallya device is intended for use in a medical office or at home Healthcare data protection The terms of the regulation EU 2016 679 of the European Parliament and of the Council o...

Страница 6: ...d concentration The molecules and associated concentrations compatible with the Mallya device are listed in the table below MALLYA MODEL INSULINE INN CONCENTRATION WARNING EXCLUDED VERSIONS MALLYA IS...

Страница 7: ...patient s smartphone Injected Insulin Dosage UI Injection Date Injection Hour The compatible Mallya mobile application allows the patient to securely display treatment information This improves the pa...

Страница 8: ...lya button 0 006 kg KWIKPEN 11 6 x 22 mm FLEXPEN 26 3 x 19 3 mm SOLOSTAR 24 4 x 20 mm Mallya total weight 0 022 kg Table 6 Weight and size of the main elements 4 SAFETY INFORMATION 4 1 SYMBOLS ON THE...

Страница 9: ...these instructions before you use Mallya for the first time Keep these instructions in a safe place The device must be used in the specified ambient conditions do not expose the device to temperature...

Страница 10: ...function Contact your authorized BIOCORP PRODUCTION dealer for inspection Mallya is not waterproof and will not be protected against the infiltration of water or moisture Do not immerse the device in...

Страница 11: ...IEC 60529 Type of protection against the access to hazardous parts and the infiltration of water as detailed in the current edition of IEC IP22 Table 9 Mains standards classification 4 5 MALLYA BASE L...

Страница 12: ...SPOSAL Dispose of Mallya according to your local guidelines According to Directives 2012 19 UE WEEE and 2011 65 UE RoHS II on the restriction of hazardous substances in electrical and electronic equip...

Страница 13: ...TOUJEO DOUBLESTAR Refer to section 2 Mallya compatibilities Molecules and concentrations 5 1 UNPACKING YOUR MALLYA AND ITS ACCESSORIES 5 1 1 PACKAGE CONTENTS Mallya base x1 Mallya button x 2 USB Cable...

Страница 14: ...2 1 CHARGING YOUR MALLYA NOTE Mallya must be charged before first time use CAUTION Mallya is supplied with a USB cable Do not use any other cable Use the cable supplied with the device to connect it t...

Страница 15: ...ase side to side to CALIBRATE Continue tilting until The base beeps and the LED light turns green Then the light will turn off NOTE If the orange LED does not light up after disconnecting the USB cabl...

Страница 16: ...allya base window is perfectly aligned with the pen dose window NOTE A pen symbol is represented on the side of the Mallya base to help you position the pen in the correct orientation square window or...

Страница 17: ...started Download the Mallya application from Once installed select the following icon to open up the application The first time you open the application you are prompted to choose the country in whic...

Страница 18: ...he next screens will guide you through the 4 operations required to start up your Mallya Switch on as explained in section 5 2 1 Charging your Mallya Calibrate as explained in section 5 2 2 Calibratin...

Страница 19: ...take few seconds Choose the insulin pen model onto which the Mallya device is assembled from the proposed list Confirm the pen model currently assembled with the Mallya device NOTE In case you cannot...

Страница 20: ...should only be used with this pen model unless you make a new adjustment Your insulin pen can now be used as usual and Mallya will track your insulin intake When Mallya is paired to the compatible mo...

Страница 21: ...riming step WARNING If the liquid does not come out of the needle tip during the safety test do not use the pen and refer to the manufacturer s injector pen user manual for more information to solve t...

Страница 22: ...lete dose injection 6 2 4 Keep the injection button pressed in and the needle in the skin While the Mallya s green LED is flashing Until Mallya emits an audible signal BEEP signaling the end of the in...

Страница 23: ...Y OF THE RECORDED DATA Select the injections icon of the application to display information related to the history of injections Injected doses or priming injections are then displayed as follows The...

Страница 24: ...o a dose see section 7 2 2 You can delete a dose or a priming see section 7 2 3 You can add an injection that was not recorded to the history see section 7 2 4 You can fill in a dose that was not capt...

Страница 25: ...Page 21 41 IFU_MAL_EN_V6 7 2 3 YOU CAN DELETE A DOSE OR A PRIMING 7 2 4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY...

Страница 26: ...EVICE The information Dose not recorded is displayed if a disturbance occurs during the injection You can add the dose information as follows Tap to modify the information related to the injection 7 3...

Страница 27: ...n pens are activated and can be used independently They both have the status Ready WARNING Make sure you do not switch the pens between the two Mallya devices In case you have any doubt you can use th...

Страница 28: ...d after approximately 2 hours 4 bars are displayed Device status This Mallya is connected or This mallya is disconnected since CAUTION A Bluetooth connection is necessary to transmit the injection dat...

Страница 29: ...ke the Mallya ring in order to identify or locate the device Only if the Mallya is on standby About Information about Mallya application Manufacturer Model Serial number Hardware revision Firmware rev...

Страница 30: ...lso available The Version of the application is displayed in the About tab 8 TRANSFERRING MALLYA TO A NEW PEN 8 1 REMOVE MALLYA FROM THE EMPTY PEN Follow the procedure indicated below when your insuli...

Страница 31: ...you may either 1 inject the amount left in your pen and then use a new pen to deliver the rest of your dose the Mallya application will then display 2 successive injections or 2 get a new pen and inj...

Страница 32: ...4 and 5 4 2 5 are displayed You have to select the new pen model on which your Mallya is currently assembled The new pen model currently assembled is then displayed at the top of the screen Apidra in...

Страница 33: ...ions data as usual if no mounting event occurred during the disconnection period eg your base and or the button have has not been removed from the original pen in the meantime or Your Mallya applicati...

Страница 34: ...the problem is not solved please contact a BIOCORP PRODUCTION authorized dealer Orange LED rapid flashing Calibration in progress Slowly tilt the Mallya side to side to calibrate see section 5 2 2 A...

Страница 35: ...too high the top of the Mallya base must be aligned with the top of the pen at the base of the dose button on the pen or if the Mallya button is not pushed on enough In this case it is necessary to ad...

Страница 36: ...he appropriate solution If the recommended solutions do not eliminate the problem or if you encounter an unlisted problem please contact a BIOCORP PRODUCTION authorized dealer INDICATION CAUSE TROUBLE...

Страница 37: ...evice and your smartphone closer to one another A communication error occurred Select Disconnected Reset Mallya as explained in the Mallya device instructions for use see section 9 3 Bluetooth issue o...

Страница 38: ...our device for a new operation 10 MAINTENANCE AND INSPECTION 10 1 MALLYA DEVICE LIFETIME Mallya and accessories expected lifetime is 2 YEARS You are not required to perform a periodic maintenance of t...

Страница 39: ...ion provided by mechanical casing and electrical enclosure against the intrusion of solid objects dust accidental contact and water Mallya is rated IP22 using this Ingress Protection rating system you...

Страница 40: ...eristics AC ADAPTOR NOT PROVIDED External Module with automatic adaptation of the voltage no selection is required Input voltage range 90 264 V Frequencies range 47 63 Hz Category II double insulation...

Страница 41: ...llowing electromagnetic environment You must ensure compliance with this guideline GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Mallya is intended for use in the electromagnet...

Страница 42: ...the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagne...

Страница 43: ...t RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND MALLYA Mallya is intended for use in an electromagnetic environment in which the radiated RF disturbances...

Страница 44: ...nes 2 kV 100Hz for power supply lines The quality of the supply voltage should correspond with one characteristic for a typical commercial or hospital environment Surge acc To IEC 61000 4 5 0 5 1 kV d...

Страница 45: ...anty does not preclude the application of current legal guarantees under national legislation governing the sale of consumer goods BIOCORP PRODUCTION is not responsible for Any damage resulting from d...

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