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FagronLab PRO, User Manual

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FagronLab™ PRO – User Manual  |  4

Dear FagronLab™ user, dear Compounder

thank you for choosing the technology. You purchased

a quality system for advanced pharmaceutical compounding.

Please read the following operation manual carefully.

For more information and compounding recommendation consult

our homepage

www.fagronlab.com 

www.fagron.com 

For additional support, operation handling and all other questions regarding

the technology

please feel free to contact your local Fagron company or dealer.

Enjoy the successful production of quality assured compounding. 

Your 

FagronLab™ 

Compounding Support Team

FagronLab™ PRO

Summary of Contents for PRO

Page 1: ...FagronLab PRO User Manual www fagronlab com ...

Page 2: ......

Page 3: ...the mixing programs After selecting the program scan of the jar size via the integrated camera or manual input by selecting jar size Quick Start FagronLab PRO How to register your FagronLab PRO device Display handling Lift arm with quick lock coupling Device activation Device identification 5AAAAAAAAAAA Please sign in to www fagronlab com re with your FagronLab ID or create a new FagronLab ID for ...

Page 4: ...eration manual carefully For more information and compounding recommendation consult our homepage www fagronlab com www fagron com For additional support operation handling and all other questions regarding the technology please feel free to contact your local Fagron company or dealer Enjoy the successful production of quality assured compounding Your FagronLab Compounding Support Team FagronLab P...

Page 5: ...e technology 21 Preparing the FagronLab mixing unit 21 Weighed portion of the formulation 21 The mixing process 22 Mixing programs 23 Requirements for components of a formulation 25 After the mixing process is complete 26 6 General notes on the FagronLab mixing system 27 Identification number ID 27 Error codes 29 Operation errors 29 Cleaning the FagronLab PRO 31 7 Service and warranty 31 Notes on ...

Page 6: ...eam at your local Fagron or official dealer in case components are missing or arrived damaged To ensure proper return without additional costs please hold on to the original cardboard box and packing material of the FagronLab PRO The warranty lapses if the original packing materials are not used for return deliveries If the device is exposed to cold weather conditions please allow the device to ac...

Page 7: ...ont Pic FagronLab PRO rear No Description 1 Touch Display 2 Automatic replaceable lift arm with quick lock coupling No Description 1 Power button emergency button 2 RS232 ports 3x 3 Socket outlet 4 USB port 4x 5 RJ45 port 1 1 2 3 4 5 2 FagronLab PRO ...

Page 8: ...e invention 1994 For the first time it is possible to not only standardize ointments but validate them too The current FagronLab mixing devices FagronLab BASIC FagronLab EMP and FagronLab PRO are useful and advanced improvements The FagronLab mixing devices feature a high safety standard They were audited for safety by TÜV Rheinland Germany The FagronLab mixing devices feature a high safety standa...

Page 9: ... additional compounding needs in the pharmacy Another beneficial feature will make stirring in medicine bottles possible Integrated standard mixing programs suspension emulsion gel etc with default mixing parameters makes the production of semi solid compounds a lot easier It is possible to rescale an already created mixing program to a different jar size to ensure the constant quality of the comp...

Page 10: ... still needs a different shaft for each See also the operation instructions that come with the disposable blade shafts The flow adapted shape of the SMB generally cleans itself during the rotating penetration of the ointment Depending on ointment s ingredients compatibility of weighted formulation and also if the jar is considerably under filled e g large volumes of powder unmixed ingredients may ...

Page 11: ...s of final quality control the mixing blade can be removed and discarded or left inside the jar Cleaning is limited to the Disp Blade shaft We also recommend using the Disp Blade for substances that may discolor the regular blade This type of stirrer also comes with different shaft lengths Every shaft is imprinted on its thinner end with the associated range of jar sizes 15 100 ml and 200 ml Disp ...

Page 12: ...eated mixing The corresponding jar lids or jar bottoms can be ordered as spare parts in sets of five and used for the economical reuse of the body Pic FagronLab jars Pic AirDynamic spindle Jars are available in following sizes 15 20 33 ml 30 42 ml 50 70 ml 100 140 ml 200 280 ml 300 390 ml 500 600 ml 1000 1250 ml and 2000 2600 ml rated volume filling volume The standard color of the jar housing is ...

Page 13: ... Eur USP e JP Certificado de análise detalhado disponível em fagronlab com coa Este produto pode ser utilizado de imediato sem limpeza prévia fr Ce produit utilise exclusivement des composants matériaux et couleurs qui suivent la réglementation en vigueur en Allemagne BedGgstVO en Europe règlement CE No 1935 2004 et aux États Unis 21CFR177 1520 4 2012 Le contrôle de la qualité est effectué en conf...

Page 14: ...pproximate values The regular dispensing nozzle in the screw lid of each FagronLab jar has a diameter of 8 mm The varionozzles or applicators reduce the diameter to 4 2 or 1 mm To ensure an exact dosage of highly active compounds it is recommended to use the ExactDose Adapter It is possible to extract an exact amount of 0 5 ml The FagronLab applicators reduce the extracted quantity of low viscosit...

Page 15: ...tem for FagronLab jar sizes 300 ml or 500 ml Extract the spindle from the jar Push carefully the bottom of the jar with a disinfected SMB if not available with a disinfected spatula all the way down Air can be diminished by placing the jar with slightly open lid loosely onto a spindle and pushing the bottom upwards Before giving the jar to the customer the safety adapter needs to be removed and th...

Page 16: ...Lab ExactDose By pressing the pump ball with its valve screw closed air is pumped into the lower chamber of the jar The thus generated pressure pushes the movable bottom up Thanks to the AirDynamic even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferred to small jars using the coupling The material outlet velocity depends on viscosity which may be reduce...

Page 17: ...elivered with your device with one of the USB ports 3 of the FagronLab PRO Use the power button to turn FagronLab PRO the device boots and is ready for operation After booting the touch screen shows the device type FagronLab PRO On initial operation the reference for the online registration at www fagronlab com re will be displayed 4 Display handling Initial operation Registration Pic Display Fagr...

Page 18: ...elow activation key to complete the device activation Activation code B8 27 EB F9 D6 3B Activate Favorite 1 Favorite 2 Favorite 3 Favorite 4 Favorite 5 Favorite 6 Soft in Soft Pre grinding Suppositories Suspension 2 NRF Suspension 2 DAB DAC Emulsion Stored Programs Emulsion Gel 1 2 3 Compounding with the FagronLab PRO On top to the right the screen displays three symbols 1 Home 2 Magnifying glass ...

Page 19: ...y clean the mixing process is finished and the lift arm will move to the removal position The mixing blade unlocks and the mixing unit can be removed During the mixing process the progress of the mixing program is displayed Following parameters are displayed 1 Mixing program 2 Jar size 3 Time passed and remaining 4 List of mixing time and mixing level 5 Stop button to abort the mixing process A su...

Page 20: ...in NRF Formulation and can be selected by pushing it The following steps are comparable using the standard mixing programs Stored programs There is the option to save often used formulation or formulation manufactured following certain criteria Select stored programs All saved programs are displayed as a list select the desired program To add a mixing program select new program and the input mask ...

Page 21: ...ion Air diminution will prevent ointment exudation at the sealing zones of the jar through reduction of any overpressure that may have developed The mixing result is also optimized since there is no trapped air Then the mixing unit should be closed by tightly screwing the jar lid down Generally oily greasy aqueous and pulverized components can be weighed out into the jar all at the same time Howev...

Page 22: ...00 1000 1200 1400 1650 1900 2150 2400 Tab Value chart rotation speed FagronLab PRO Quick lock coupling Pic Quick lock coupling Hold the FagronLab logo on top of the jar to the front Load the stirring shaft directly from the front into the lift arm Push the mixing unit up and with a slight turn counterclockwise about a quarter turn fix the mixing unit into the lift arm Push the start button on the ...

Page 23: ...program Suspension 2 Suspension 2 After finalising the pre grinding process both the remaining foundation and all active substances will be weighed in Therefore move the jar bottom by using a spatula all the way down to add the remaining components To incorporate air as little as possible push the movable jar bottom up until resistance is felt Suspension 2 With the mixing program Suspension 2 soli...

Page 24: ...water bath or microwave The melting components can be melted directly in the jar If there is no water in the formulation the components can be melted directly in the jar on a hot water bath Formulation containing an aqueous phase can be melted in a hot water bath or the microwave leave the regular nozzle open and set the microwave to a low power setting The temperature control with a thermometer s...

Page 25: ...ed with mixing programs for selected DAB DAC formulation and standard preparations Stored Programs The menu option Stored Programs gives the possibility to enter the mixing time and the mixing speed in six different mixing parameters to create an individual mixing program It is also possible to enter the mixing program using a known or before created ID number Specialties With the mixing parameter...

Page 26: ...re rise for both jar and its content must be avoided all the time The cooling time and the cooling interval can be decreased by using a refrigerator or a cooling cuff The stirrer should remain in the jar during the cooling phase Thermolabile substances Active substances or components with thermolabile characteristics should be processed with caution To protect the substances we recommend a maximum...

Page 27: ... on the jar prior forwarding to the client preferably together with a short illustration of how to use and apply the FagronLab dispensing system After completion of every single process the FagronLab PRO issues automatically an identification number ID The display shows the ID and it conducts an easier documentation and an exact reproduction of the mixing process The FagronLab mixing parameters ar...

Page 28: ...lates to a defined rpm value FagronLab jar 1 2 3 4 5 6 7 8 9 Jar size in ml 15 20 30 50 100 200 300 500 1000 A B C D E F G H I J K L M mm ss 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 40 0 45 0 50 0 55 1 00 1 05 a b c d e f g h i j k l m mm ss 2 20 2 30 2 40 2 50 3 00 3 10 3 20 3 30 3 40 3 50 4 00 4 20 4 40 N O P Q R S T U V W X Y Z mm ss 1 10 1 15 1 20 1 25 1 30 1 35 1 40 1 45 1 50 1 55 2 00 2 05 2 10 ...

Page 29: ...the device Error Troubleshooting 1 The stirrer used is not compatible with the FagronLab PRO The stirrer used is not an original FagronLab stirrer The FagronLab PRO has only been tested centered and aligned with original FagronLab stirrers All stirrers delivered after the year 1996 are compatible with the FagronLab PRO 2 There are problems while coupling the stirrer with the FagronLab PRO The Fagr...

Page 30: ...he sealing lip of the bottom with foundation After using the jar in a water bath water accumulated in the cavity on the bottom side of the jar The water cannot penetrate into the jar itself through the sealing lip remove the excess water with a paper towel 5 The jar does not attach into the lift arm The jar is not an original FagronLab jar Always use an original FagronLab jar Please observe the co...

Page 31: ...ors common errors Common errors Cleaning the FagronLab PRO Always unplug the FagronLab PRO from the wall outlet before performing a cleaning Do not use aggressive cleaning agents or abrasive cleaners For cleaning we recommend daily wiping the surface with a damp cloth with mild detergent and immediately drying it with a dry cloth For disinfecting the display can be lightly sprayed and wiped with i...

Page 32: ...in case of an emergency or pull the power plug Using the FagronLab devices not according to these operating instructions or with line products that the manufacturer did not deliver or recommend may impair safety FagronLab devices have not been designed for operation under hazardous conditions Heed the relevant safety regulations when handling hazardous substances e g combustible liquids such as al...

Page 33: ...ko International GmbH D 96110 Schesslitz is DIN EN ISO 9001 2015 certified For inquiries regarding FagronLab technology products please refer to your local Fagron company or official dealer Customer Service With all inquiries about technical data service warranty customer service or replacement parts contact the customer service of your local Fagron company or official dealer 8 Manufacturing and C...

Page 34: ...FagronLab PRO Notes ...

Page 35: ......

Page 36: ...Together we create the future of personalized medicine Fagron Hellas 12 km N R Trikala Larisa P C 42100 P O Box 32 Trikala Greece T 30 24310 83633 5 F 30 24310 83615 www fagron gr P R OU M 01 ...

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