Table of Contents
Troubleshooting
Related Manuals for BIOCORP Mallya Novo Nordisk
Summary of Contents for BIOCORP Mallya Novo Nordisk
- Page 1 01-2021 Instructions For Use ® ® ® ® Designed for Flexpen Novo Designed for Kwikpen Eli Lilly Designed for Solostar Sanofi Nordisk Embedded software versions 3.6. and over Helping you keep track of your insulin doses IFU_MAL_US_V1.13...
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Page 2: Table Of Contents
TABLE OF CONTENTS SYMBOLS IN THESE INSTRUCTIONS FOR USE ................... 4 STORAGE ..............................4 WARNINGS & CAUTIONS ........................5 FCC STATEMENTS ........................... 6 DIRECTIONS FOR USE ........................7 FEATURES ..........................7 INTENDED USE ........................7 MALLYA COMPATIBILITIES WITH PENS ..................8 GETTING TO KNOW YOUR MALLYA DEVICE ................ - Page 3 TRANSFERRING MALLYA TO A NEW PEN ................. 28 REMOVING MALLYA FROM THE EMPTY PEN ..............28 TRANSFERRING MALLYA TO A NEW PEN WITH SELECTING THE “MOVE MALLYA TO A NEW PEN” BUTTON ..........................28 TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE “MOVE MALLYA TO A NEW PEN”...
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Page 4: Symbols In These Instructions For Use
SYMBOLS IN THESE INSTRUCTIONS FOR USE Symbol Meaning Signification Improper operation may result in WARNING serious injury* or death to the user, patient Improper operation may result in CAUTION bodily injury* or property damage* Disconnect the device from power CAUTION supply before servicing/cleaning NOTE Important information for operation... -
Page 5: Warnings & Cautions
In case of malfunctioning, please contact a BIOCORP PRODUCTION authorized dealer for technical support. - Mallya is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port. -
Page 6: Fcc Statements
STATEMENTS MALLYA Models: 0273694-KWKP, 0273778-FLXP, 0273777-SLST FCC ID: 2AYCW-EZL CAUTION: - This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 7: Directions For Use
DIRECTIONS FOR USE FEATURES Mallya is composed of a base and a knob that can be mounted on a disposable insulin pen. Mallya knob Mallya base Mallya allows you to: - record the injected selected increment (insulin dose), - record the day and time when each insulin dose was injected, - transmit the dose, day/time when each insulin dose was injected to a compatible mobile app. -
Page 8: Mallya Compatibilities With Pens
MALLYA COMPATIBILITIES WITH PENS WARNING Make sure Mallya is compatible with your pen (insulin type and concentration). The molecules and associated concentrations compatible with the Mallya device are listed in the table below: WARNING EXCLUDED VERSIONS MALLYA MODEL INSULINE INN CONCENTRATION MALLYA IS NOT COMPATIBLE WITH... -
Page 9: Getting To Know Your Mallya Device
GETTING TO KNOW YOUR MALLYA DEVICE GETTING STARTED The shipment box contains the following items. The Part Numbers (PN) vary depending on the Mallya model (Mallya designed for FLEXPEN or KWIKPEN or SOLOSTAR): Mallya DEVICE: 1 X Mallya BASE ® For the insulin pen FLEXPEN NOVO NORDISK: PN: 0273778... -
Page 10: Features Of Your Mallya
FEATURES OF YOUR MALLYA Knob Micro Clear square USB port dose window WEIGHT AND SIZE OF THE MAIN ELEMENTS Element Weight Size ® KWIKPEN base: (60.8x28.9x21.3) mm Mallya base 0.016 kg ® ® FLEXPEN and SOLOSTAR bases: (60.8x26.9x21.3) mm KWIKPEN ®... -
Page 11: Transport And Packaging
Mallya connects your insulin pen to your smartphone! Use the Mallya smartphone application to keep track of your insulin doses. TECHNICAL COMPATIBILITIES The list of smartphones validated by BIOCORP and compatible with the Mallya application Version 1.7. is shown below: SMARTPHONE MODEL... -
Page 12: Download The Mallya Application And Get Started
DOWNLOAD THE MALLYA APPLICATION AND GET STARTED Download the Mallya application from: Once installed, select the following icon to open up the application: The first time you open the application, the Mallya application terms of service screen is displayed. Please read the Mallya application terms of use before accepting them and confirming your choice. -
Page 13: Caring For Your Mallya
CARING FOR YOUR MALLYA 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 to a USB power port. You cannot use your Mallya for an injection while it is connected to a USB power port and charging. -
Page 14: Calibrating Your Mallya
CALIBRATING YOUR MALLYA 4.2.1. Unplug the Mallya base from the USB cable. 4.2.2. Check that the Mallya LED is flashing orange. 4.2.3. Slowly tilt the Mallya base side to side to CALIBRATE. 4.3.3. Continue tilting until: The base beeps and the LED light turns green. -
Page 15: Attaching Your Mallya To Pen
ATTACHING YOUR MALLYA TO PEN CAUTION The Mallya base and knob must be correctly attached onto the pen, otherwise, data will not be transferred. 4.3.1 ATTACHING BASE TO PEN 4.3.1.1. Hold the Mallya base so that the clear square plastic window is facing you 4.3.1.2. - Page 16 CAUTION The Mallya base LED remains orange the clear square plastic window of the Mallya base and the dose window of the pen are not correctly aligned, or, the Mallya knob is not pushed on enough. In this case, it is necessary to: Re-adjust (re-align) the windows, or, push on the knob, until the Mallya base LED flashes...
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Page 17: Pairing Your Mallya
PAIRING YOUR MALLYA To pair the Mallya device to the BIOCORP Mallya application, follow the steps indicated below: 4.4.1. 4.4.2. Make sure the Mallya base is within 12 inches Select “Pair” of your smartphone and select “Start pairing”: NOTE: The pairing step may take few seconds. - Page 18 4.4.5. 4.4.6. Well done! Your Mallya device is now paired The injection screen is displayed. with Mallya application your smartphone. Select “OK” to move on to the injection screen. CAUTION From now on, this Mallya should only be used with this pen model, unless you make a new adjustment.
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Page 19: Using Your Insulin Pen With Mallya
USING YOUR INSULIN PEN WITH MALLYA NOTE : Once Mallya is attached to the insulin pen, the pen should be used just like a normal insulin pen. Refer to the manufacturer’s injector pen Instructions for Use. SECURITY TEST - PRIMING WARNING Always perform a priming (safety test) before each injection to ensure that: ... -
Page 20: Injection
INJECTION WARNING If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider. 5.2.1. Check the insulin dose to inject as requested by the drug manufacturer’s requirements. 5.2.2. -
Page 21: Managing Recorded Data
MANAGING RECORDED DATA Once data is transferred from a paired compatible Mallya, you can display and manage any recorded data using the Mallya application as follows: DISPLAY OF THE RECORDED DATA Select the injection screen: “Doses” or “Priming” injections are then displayed as follows: DOSES PRIMING The Insulin Dose information is displayed:... -
Page 22: Manage Your Recorded Data
MANAGE YOUR RECORDED DATA You can manage and edit the following list of items: - You can change a “priming” or a “dose” quantity (see step 6.2.1.), - You can change an injection recorded as a “dose” to a “priming”, or a “priming” to a “dose” (see step 6.2.2.), - You can delete a “dose”... -
Page 23: You Can Delete A "Dose" Or A "Priming
6.2.3 You can delete a «dose» or a «priming» 6.2.4 You can add an injection that was not recorded to the history To add an unrecorded dose, select “Add to log”: P a g e 23 | 44 IFU_MAL_US_V1.13_January 2021... -
Page 24: You Can Fill In A Dose That Was Not Captured By The Device
6.2.5 You can fill in a dose that was not captured by the device If a dose was not captured, you will see the message “Dose not recorded”. You can add the dose information as follows: to modify the information related to the injection: OTHER FEATURES OF THE MALLYA APPLICATION GENERATE A REPORT In the “Injections”... -
Page 25: Pair Two Mallya To Your Mobile App
PAIR TWO MALLYA TO YOUR MOBILE APP. Mallya Devices screen Both Mallya devices and associated insulin pens can be used independently. They both have the status “Ready for use”: WARNING Make sure you do not switch the pens between the two Mallya devices. In case you have any doubt, you can use the “Find the device”... -
Page 26: Settings
SETTINGS Select , then “Settings” to diplay the screens allowing to set up the application: Mallya Devices screen Battery status : When Mallya is fully charged (after approximately 2 hours) : 4 bars are displayed Device status: Mallya is connected / Disconnected since … CAUTION A Bluetooth connection is necessary to transmit the injection data. -
Page 27: Help" Screen
Find the device: select this option to make the Mallya ring* in order to identify or locate the device. *Only if the Mallya is in STANDBY mode. “About” Information about Mallya application: - Manufacturer - Model - Serial number - Hardware revision - Firmware revision - Software revision - Temperature... -
Page 28: Transferring Mallya To A New Pen
TRANSFERRING MALLYA TO A NEW PEN REMOVING MALLYA FROM THE EMPTY PEN Follow the procedure indicated below when your insulin pen is empty: 8.1.1. Remove the Mallya base from the insulin pen. Use your thumb to press on Mallya and to remove it from the pen. - Page 29 NOTE : It is not necessary to pair your Mallya again when changing the pen (unless your system has been reset - see step 9.3. Reset instructions). 8.2.3. Moving Mallya to the same pen model or to a different pen model The same pen model, currently 8.2.3.1 assembled, is then displayed at the...
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Page 30: Transferring Mallya To A New Pen Without Selecting The "Move Mallya To A New Pen" Button
TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE “MOVE MALLYA TO A NEW PEN” BUTTON CAUTION When Mallya is transferred onto a new pen without selecting the button, the application automatically detects a “device removal event” (eg.: your base and / or the knob have / has been removed from the original pen). - Page 31 The following screen is displayed with 2 options to choose from: YES, this device is exclusively used with NO, I have placed this device on another the same type of pen (same as the original type of pen. pen). In this case, the injection dose will be 1) In this case, the screens in steps 4.4.3., displayed in the injection history as if no 4.4.4., and 4.4.5.
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Page 32: Collect Your Injection Data From Mallya After Smartphone Disconnection
Example with the pen model "APIDRA" selected (used for the injection) COLLECT YOUR INJECTION DATA FROM MALLYA AFTER SMARTPHONE DISCONNECTION Your smartphone may disconnect from the Mallya system if Bluetooth is out of range, or the battery is empty, or for other potential reasons. In this case, you can still use Mallya to record your insulin doses and, on the next connection, data will be automatically transferred from Mallya to your smartphone. -
Page 33: Troubleshooting
- Never attempt to access the internal hardware for any purpose including maintenance in all circumstances. - When a function check is not successful and if the recommendations given in this step 9. do not solve the issue, you are prompted to contact a BIOCORP PRODUCTION authorized dealer. TROUBLESHOOTING MALLYA WITH BASE SIGNALS... - Page 34 CAUTION ORANGE LED – TROUBLESHOOTING RECOMMENDATIONS The Mallya base light indicator (LED) remains orange a) The clear square plastic window of the Mallya base and the dose window of the pen are not correctly aligned, or b) The Mallya base is mounted too high / too low on the pen, c) Or, if the Mallya knob is not pushed on enough.
- Page 35 INFORMATIONS REGARDING OTHER SIGNALS: SIGNAL CAUSE TROUBLESHOOTING STEPS Green LED (slow flashing) Mallya is charging. (See step 4.1.) Mallya is properly assembled Green LED onto the pen. It is: - either ready for use, or - the dose setting is in progress, or - the injection is in progress Green LED (rapid flashing)
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Page 36: Troubleshooting Mallya With The Application
Find the problem you are experiencing among those listed in the following list and apply the 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 TROUBLESHOOTING STEPS ①... - Page 37 ③ Check the Bluetooth connection status on your mobile phone. If the problem is not solved, please contact a BIOCORP PRODUCTION authorized dealer. Table 8 - Troubleshooting with app. (next) P a g e 37 | 44 IFU_MAL_US_V1.13_January 2021...
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Page 38: Reset Instructions
RESET INSTRUCTIONS The reset procedure of Mallya may be necessary: - If Mallya is not working properly (no response, etc…), - If you need to pair Mallya with another mobile phone (smartphone), - If you want to delete your personal health data from the device. PROCEDURE: 9.3.1. -
Page 39: Maintenance And Inspection
10. MAINTENANCE AND INSPECTION 10.1 MALLYA DEVICE LIFETIME Mallya and accessories lifetime is 2 YEARS. 10.2 MALLYA APPLICATION UPDATES Check each week on your smartphone (in the Apple store / Play store) if a Mallya application update is available, and update when available. 10.3 CLEANING YOUR MALLYA When the surface of Mallya is dirty, follow the steps indicated below to clean it: ... -
Page 40: Technical Specifications
- If the device is dropped or receives an impact, its water and dust resistance may be impaired. 11. TECHNICAL SPECIFICATIONS 11.1 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS COMPLIANT DESCRIPTION CLASSIFICATION STANDARDS Protection type against electric shock Class II (double isolation) ... -
Page 41: Symbols On The Device And Its Packaging
11.3 SYMBOLS ON THE DEVICE AND ITS PACKAGING SYMBOL STANDARDS DESCRIPTION IEC60417-5840 Applied part Type BF ISO7010-M002 Please refer to the Instructions for Use document ISO 15223-1 Consult the Instructions for Use documents ISO 15223-1 Do not use if the packaging is damaged ISO 15223-1 Manufacturer ISO 15223-1... -
Page 42: Electrical Ratings
SYMBOL STANDARDS DESCRIPTION Symbol 5.3.9 (ISO 7000- Pressure limits within which the device can be safely 2621) of ISO 15223- exposed 1:2012 Table 12 - Symbols on the device and its packaging (next) 11.4 ELECTRICAL RATINGS CAUTION Make sure you connect the Mallya USB cable to a power source compliant with the IEC 60601- USB CHARACTERISTICS Input voltage 5V DC 2A... -
Page 43: Disposal
CAUTION External factors may affect the dose measurement accuracy. Does not affect the Factors Affect the measurement measurement Ambient Temperature √ Magnetic disturbance √ Dose Knob position √ Table 16 - External factors and measurement accuracy To display accurate doses, make sure to use the device as recommended in this Instructions for Use document: - Follow the Warning and Caution recommendations to avoid magnetic disturbance - Follow the information given step 4.3.2. -
Page 44: General Information
Biocorp Production and users of its products. To this end, Biocorp Production agrees to comply with its obligations in accordance with the regulation applicable to Personal data protection and makes every effort to guarantee the security, confidentiality, and integrity of the Personal data that it may process.
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