manualshive.com logo in svg

BIOCORP Mallya, Instructions For Use Manual

BIOCORP Mallya is a state-of-the-art medical device that revolutionizes the way insulin is administered. Ensure proper usage with the Instructions For Use Manual available for free download. Simply visit manualshive.com to get your hands on the comprehensive manual and enhance your experience with this innovative product.

Share
Download
background image

 

 

Page 33 / 41 

IFU_MAL_EN_V6

 

INDICATION 

CAUSE 

TROUBLESHOOTING STEPS 

 

 

 

 

 

Calibration error 

①

 Select 

“

Error

”

 

②

 

Perform the calibration as indicated in the 

Mallya

 

device instructions for use (see 

section 5.2.2.

) 

 

 

 

Mallya is maybe too 

far away from your 

smartphone and 

therefore 

disconnected 

Or 

①

 

Move your Mallya device and your 

smartphone closer to one another.

 

A communication 

error occurred 

①

 

Select 

“

Disconnected

”

 

②

 

Reset Mallya as explained in the Mallya 

device instructions for use (see 

section 9.3.

) 

 

 

 

Bluetooth issue or 

signal lost 

①

 

Check that the Mallya device is powered 

ON. 

②

 

Check that the Mallya device is connected 

to the App. 

③

 

Check the Bluetooth connection status on 

your mobile phone. 

 

If the problem is not solved, please contact a 

BIOCORP PRODUCTION authorized dealer. 

Table 16 - Troubleshooting with app. (next) 

 

 

Summary of Contents for Mallya

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Reviews:

No comments

Related manuals for Mallya

Brands by name

Popular brands

Load more brands