Gako Unguator e/s Operating Instructions Manual Download Page 44 | Manualshive

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44

Manufacturer’s Certificate

Manufacturer’s Certificate

All

plastic line items

are exclusively produced from materials and color components that meet the

preconditions for the

Regulation on Consumer Articles of the Federal Republic of Germany dated

4/10/1992,

the recommendation of the Federal Public Health Department (BGA) from

1993 for objects in contact with foodstuffs

and the

EU Directive 2002/95/EC (RoHS).

Article

1)

Material

2)

Color concentrate

2)

Jar

3)

Standard

Cosmetic

Jar cap

Polypropylene, natural

white

colored

Jar lid

Polypropylene, natural

red, white, green, blue

colored

Jar housing

Polypropylene, natural

white

colored

Jar bottom

Polypropylene / Polyethylene

-

-

Jar bottom cap

Polypropylene, natural

white

white

Further

line items

Spindle

Polypropylene, natural

white

Applicator long with cap

Polypropylene, natural

white

Applicator short with cap

Polypropylene, natural

white

Coupling

Polypropylene, natural

white

Varionozzle

blue, yellow, pink

Polypropylene, natural

blue, yellow, red

SMB

Polyoxymethylene white

-

Disp. Blade

Polyamide white

-

1) The licensed manufacturer, SMS ELAP GmbH, D-98544 Zella-Mehlis is DIN EN ISO 9001:2000 certified
2) Declarations of conformity for materials and color concentrates of the materials vendors are deposited at the licensed manufacturer.
3) With certificate of analysis according to ZL Packing Instruction DK II / 1994 on the packaging hose.

GAKO Konietzko GmbH

D-96049 Bamberg / Germany

Dipl.-Wirtsch.-Ing. Matthias Konietzko

Production control

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Summary of Contents for Unguator e/s

Page 1: ......

Page 2: ......

Page 3: ...xing System 19 2 2 Weighing in the formulation constituents 19 2 2 1 Emulsion 20 2 2 2 Emulsion 20 2 2 3 Normal 21 2 2 4 Suspension 2 21 2 2 5 Suspension 2 22 2 2 6 Gel 22 2 2 7 Suppositories 23 2 2 8 Powder 23 2 2 9 General notes 23 2 3 Preparing the mixing process 25 2 4 The mixing process 25 2 5 After the mixing process is complete 25 3 The mixing process using the UNGUATOR e s 27 3 1 Operation...

Page 4: ... assurance of the ointments 38 5 Service and warranty 39 5 1 Notes on malfunctions 39 5 2 Manufacturer s service and warranty in Germany 39 6 Bibliography 41 7 Notes on safety 42 8 Technical data of the UNGUATOR e s 43 9 Manufacturer s Certificate 44 10 Distribution manufacturing and customer service 45 11 WARRANTY CERTIFICATE 46 12 Document template 48 ...

Page 5: ...dle 16 Fig 1 14 Transfer using a 200 ml UNGUATOR Jar 17 Fig 1 15 UNGUATOR Coupling 17 Fig 1 16 AirDynamic System 18 Fig 3 1 Control panel ofthe UNGUATOR e s 27 Tab 3 1 Value table of the speed steps 28 Tab 3 2 Minimum values for mixing time at speed step 9 in min sec 30 Tab 3 3 Minimum values for mixing time at speed step 5 in min sec 31 Tab 3 4 Minimum values for mixing time at speed step 1 in mi...

Page 6: ...reme humidity or temperature fluctuations Clean dry and dust free Remove all components from the cardboard box Check to ensure that the following components were included in shipment UNGUATOR e s Operating instructions Please contact customer service at SMS Elap GmbH Co KG in the event that components are missing or damaged Contact information is at the end of these operating instructions Keep the...

Page 7: ...em To continue to ensure that this is remains so GAKO Konietzko GmbH consistently strives to both maintain and improve the quality of the UNGUATOR Mixing System To achieve this aim we continue to search for efficient improvements in addition to periodic quality controls This objective is actively supported by application of vast know how of the inventor of the UNGUATOR Mixing System pharmacist Alb...

Page 8: ...0 work hours which corresponds to approximately 15 000 to 20 000 prescriptions The UNGUATOR mixing machines feature a high safety standard and were tested by TÜV Rhineland for their safety They are manufactured under license and maintained by SMS Elap GmbH Co KG in Zella Mehlis Germany Product quality product uniformity and reproducibility of ointments prepared individually and in batches were imp...

Page 9: ...itable displacement motion during the mixing process If the stroke length of the first stroke was taken as a constant value then the active ingredient weighed in into the lower region of the UNGUATOR Jar might not be included in the mixing process by the UNGUATOR Mixing Blade getting lost at the bottom The lifting technique of the UNGUATOR Mixing System prevents this from happening so that the res...

Page 10: ...ing Blade to rotate at lower speed while UNGUATOR Jar quickly travels up and down or vice versa This new function is particularly useful using a low rotating speed of the UNGUATOR Mixing Blade since it allows the UNGUATOR Mixing Blade to mix an ointment homogeneously by slow stroke 1 3 UNGUATOR Assortment In addition to the UNGUATOR Standard Mixing Blade SMB the UNGUATOR Disposable Blade Disp Blad...

Page 11: ...ATOR SMBs are adjusted to the size of each individual UNGUATOR Jar While the UNGUATOR SMBs for 100 and 200 ml and for the 300 and 500 ml jars have the same mixing blade diameter their shaft length differs This must be taken into consideration particularly when using the UNGUATOR e s and the UNGU ATOR 2100 since the use of the wrong length may cause problems with the automated stroke Always make su...

Page 12: ...bstances that may discolor the regular blade This type of UNGUATOR MB also comes with diffe rent shaft lengths On the weak end of the shaft the range of UNGUATOR Jar sizes that can be used 15 100 ml and 200 ml respectively for the application is marked for orientation 1 3 2 UNGUATOR Jar The UNGUATOR Jar is both the mixing and the dispensing jar and is therefore designed as an expendable or disposa...

Page 13: ...00 ml and 1000 1250 ml rated volume filling volume The standard color for the UNGUATOR Jar housing is white and the UNGUATOR Jar Lid is red The 300 ml 500 ml and 1000 ml UNGUATOR Jars come with white lids In addition the 20 ml to 100 ml UNGUATOR Jars are available in the pastel colors pink light yellow light blue and turquoise Furthermore UNGUATOR Jars from 20 to 200 ml can be ordered with UNGUATO...

Page 14: ...materials at the pharmacy stipulates that the manufacturer s test certificate certificate of analysis after visual receiving inspection be retained This certificate is affixed to the plastic wrapping in which the UNGU ATOR Jars are packed It may be removed from the plastic wrapping as needed and added to the records 1 3 3 UNGUATOR Varionozzles The UNGUATOR Varionozzles with inner diameters of 1 2 ...

Page 15: ...NGUATOR Applicator long The UNGUATOR Applicator long with an opening diameter of 2 mm allows formulations to be introduced into large orifices of the body or probes Moreover the UNGU ATOR Applicator long is also available as a sliding aid together with the 200 ml UNGUATOR Jar 1 3 5 UNGUATOR Spindle The UNGUATOR Spindle serves as a dispensing system for the 200 ml or 500 ml UNGUATOR Jar The spindle...

Page 16: ...ar Caution If the movable bottom is accidentally perforated or the spindle locks onto the insert per manently then the UNGUATOR Jar may only serve as dispensing or storage vessel and cannot be used for the mixing process 1 3 6 UNGUATOR Coupling The UNGUATOR Coupling connects two UNGUATOR Jars by the threads of their dispensing openings and is very useful when preparing ointments in larger batches ...

Page 17: ...using the AirDynamic Sys tem We recommend transferring the formulation as soon after mixing as possible since the formulation has then hardly cooled and is still warm and less viscous 1 3 7 AirDynamic System The AirDynamic System optimizes batch preparation within the closed system contamination free transfer contamination free storage The AirDynamic System has been designed to use UNGUATOR Jars f...

Page 18: ... is certified in accordance with DIN EN ISO 9001 Periodic quality controls not only guarantee the outstanding but also most notably the lasting quality of the UNGUATOR Mixing System UNGUATOR Applicators couplings and jars are made of polypropylene PP and the UNGUATOR Varionozzles of polyethylene PE The head of the UNGUATOR SMB is made of polyoxymethylene POM and the mixing blades of the UNGUATOR D...

Page 19: ... the mixing process Third the UNGUATOR MB is removed from the UNGUATOR Jar housing by pulling with a slight counterclockwise turn The UNGUATOR Jar Lid will be moved in Mixing Blade direction Both parts i e the UNGUATOR MB and UNGUATOR Jar lid are put down or possibly tared on the balance together with the UNGUATOR Jar housing 2 2 Weighing in the Formulation Constituents Generally oily greasy aqueo...

Page 20: ...ion Emulsifying semisolid substances with water at room temperature Example Eucerin c aqua aa We recommend using the UNGUATOR Disp Blade Emulsification can be more difficult using refrigerated foundations Emulsification can be sped up by heating the water to be added however often the heat that develops inside the Jar during the mixing process may already be sufficient Adapted emulsifiers can afte...

Page 21: ...Normal Mixing semisolid substances from low viscous to paste state Examples Ready made pharmaceutical ointment with foundation s concentrated active substances with foundation s liquid active ingredients in foundation s First the foundation ointment should be weighed in into the UNGUATOR Jar Then the remaining constituents should be weighed 2 2 4 Suspension 2 Mixing semisolid substances with a por...

Page 22: ... salicylicum urea in aqueous foundation We recommend using the UNGUATOR SMB The preparation of a pre ground substance is can be skipped for suspensions with more than 2 content of active ingredients in favor of mixing time extension First of all the foundation should be rendered on weighing in Then the liquid constituents should be weighed in Finally the solid constituents are filled into the UNGU...

Page 23: ...r the UNGUATOR Jar sizes 300 500 and 1000 ml To minimize the grinding noise along the sealing lip in the UNGUATOR Jar Lid when mixing powder the lip may be widened a bit using the shaft of the UNGUATOR MB or vaseline or paraffinum liquidum may be applied to the shaft of the UNGUATOR MB The powder can be evenly distributed from the dispensing opening using the capsule filling device 2 2 9 General N...

Page 24: ...ave then mix them using the UNGUATOR Please note that the UNGUATOR MB cannot go into the microwave Furthermore isolated areas of heat concentration may develop when heating in a microwave To avoid this we recommend coarsely blending the content of the jar during heating using a spatula at intervals Please also keep in mind that a microwave will only heat aqueous substances Generally it is sufficie...

Page 25: ...ermingling large quantities of powder that air diminuation be repeated after 15 seconds of the mixing process When pregrinding by pasting the solids with some foundation in the UNGUATOR Jar we recommend positioning the movable UNGUATOR Jar Bottom as far downward as possible This will guarantee that the large surface area of the inside wall of the UNGUATOR Jar also including the lid and bottom can ...

Page 26: ...la When using the UNGUATOR Disp Blade the mixing blade can be removed from the UNGUATOR Jar and disposed or or left in the UNGUATOR Jar Leaving the blade in the jar will have no effect on dispensing the ointment through the UNGUATOR Jar Lid Removal of the mixing blade is recommended particularly when giving the ointment to elderly users since it might otherwise cause confusion if the ointment is t...

Page 27: ... the AUTO HAND button when the device is switched on to select manual or automatic operation The current setting is indicated on the display where either the triangle above the AUTO for auto mode or beneath HAND for manual operation lights up The oscillating arm of the UNGUATOR e s will automatically move to the corresponding position when operating mode is changed When automatic manual stroke ope...

Page 28: ...at all The mixing process will continue once the UNGUATOR is detected by the sensor The programmed mixing time will be completed at the set speed step with steady up and down movement of the UNGUATOR Mixing System The mixing time and speed parameters can also be changed during the mixing process using the same procedure for initial programming of the mixing process Freespin can be done when mixing...

Page 29: ...UNGUATOR Jar bottom to the stop on the UNGUATOR Jar Lid every second while holding the UNGUATOR Mixing System tightly with at least one hand The UNGUATOR Mixing System can be switched to freespin as a special step with manual stroke movement Press the Start Stop before the mixing process is complete to switch to freespin This will interrupt the mixing process and the display will prompt for freesp...

Page 30: ...lay will then show the mixing time up to this point stage Air could then be reduced after a large volume of powder has been added for example The device will reboot when the Start Stop button is pressed again The operation mode HAND should only be selected for UNGUATOR Jars in sizes 15 to 100 ml UNGUATOR Jars from 200 to 500 ml should either be guided using both hands or even better guided in oper...

Page 31: ... 05 45 07 15 Suspension 2 04 10 05 15 08 15 10 20 Suppositories 02 10 03 10 05 45 07 15 Gel 25 min 6 times 10 strokes each with 5 breakes á 04 30 at 1750 rpm Tabelle 3 3 Minimum values for mixing time at speed step 5 in min sec Size of the UNGUATOR Jar Type of formulation 15 to 20 ml 30 to 100 ml 200 to 300 ml 500 ml Emulsion 10 10 13 30 22 00 27 00 Normal 06 45 10 10 18 40 23 45 Suspension 2 13 3...

Page 32: ...oot HAND mode FE 9 Oscillation arm will automatically No mixing unit attached to oscillation arm return to home position in AUTO mode FE 9 Remove jar and No mixing unit snapped in or released hit the Start Stop button in AUTO mode FE A Hit the Start Stop button Temporary motor overload possibly switch off device Table 3 5 UNGUATOR e s error messages Error messages will also occur if UNGUATOR MBs a...

Page 33: ...a closed system no transfer into a separate dispensing jar 2 3 4 8 Hygienic product extraction low risk of contamination through the user 2 3 4 8 Improved product quality in improved packaging guaranteed extended product durability 3 4 4 2 Notes on the Mixing Process This subchapter serves to clarify frequently asked questions and clear up possible misunderstandings Adhering to the following tips ...

Page 34: ...rating instructions that come with the shafts 4 2 2 Niches of Flow on the UNGUATOR SMB The flow adapted shape of the UNGUATOR SMB generally cleans itself during the rotating penetration of the ointment Unmixed constituents may adhere to niches of flow of the UNGUATOR SMB depending on ointment constituents compatibility Fig 4 1 Assignment of the UNGUATOR SMB with different length of shaft ...

Page 35: ...f water approx 10 and water ad 70 54 C 129 F was the maximum temperature measured after 6 minutes of mixing the highly pasty preparation made of vaseline and zinc oxide aa under full speed This temperature increase is generally safe for the substances employed in the pharmaceutical field Ointments of low viscosity only heat slightly 2 Volatile substances such as ethereal oils or alcohol do not eva...

Page 36: ...rushed with foundation so as to improve its sealing quality The sealing lip of the UNGUATOR Jar Lid is damaged by the shaft tappets of the UNGUATOR MB upon perforating the lid This will cause ointment to creep up the shaft The UNGUATOR Jar Lid is not tightened correctly and not held during the manually guided stroke This may cause the UNGUATOR Jar Lid to untwist during the mixing process resulting...

Page 37: ...ty of ointment to be applied using approximate values The dispensing openings in the screw lid of the UNGUATOR Jars all have the same diameter The varionozzles or applicators reduce the diameter to 4 2 or 1 mm The approximate values represented in the following diagrams may also be helpful when weighing in concentrated active substances or regular comminutions from the UNGUATOR Jar Fig 4 3 Opening...

Page 38: ...lene blue 4 Here the examination of ointment streaks from various levels of the mixing jar using a magnifying glass or microscope have demonstrated the success of the mixing process as has viewing one or more sections of an ointment block that can be pressed out of the UNGUATOR Jar as a whole after it was placed into a freezer overnight Mixing up such analog formulations not only ensures that UNGU...

Page 39: ...he course of maintenance work periodically carried out by SMS Elap GmbH Co KG Should faults or damage occur please also read the manufacturer s notes on the underside of the base 5 2 Manufacturer s Service and Warranty in Germany The manufacturer will accept independent from the obligations of the vendor against the buyer a warranty period of twenty four 24 months from the date of purchase for the...

Page 40: ... date of purchase dealer s stamp and signature or the purchase receipt in connec tion with the warranty certificate is provided Repairs within the framework of warranty will be exclusively carried out by SMS Elap GmbH Co KG or companies authorized by it To preserve gears and motor for further undisturbed operation the UNGUATOR e s should either be sent to your respective representative in your ind...

Page 41: ...System zur Salbenherstellung im Vergleich Pharmazeutische Zeitung PZ Nr 38 Jhg 143 1998 S 53 65 R Eifler Bollen Zentrallaboratorium Deut scher Apotheker ZL Eschborn 8 Voigt R Pharmazeutische Technologie Für Studium und Beruf Jhg 2000 9 Auflage S 314 315 Deutscher Apothekerverlag Stuttgart 9 Qualitätssicherung bei Rezeptur und Defektursalben UNGUATOR Techno logie Apotheker Wirtschaft Nr 7 Jhrg 2 20...

Page 42: ...e Do not touch rotating parts Keep long hair away from rotating parts During the automatic lifting function of the UNGUATOR 2100 always keep long hair parts of the body or objects away from the lifting mechanism immediately turn off the power switch in an emergency or pull the power plug Always keep the air vents on the driving head back or underside of the devices free when using the device Using...

Page 43: ...y UNGUATOR Jar sizes 15 500 ml Weight 20 44 lbs Dimensions L x W x H in mm 300 x 300 x 650 Testing certifications TÜV GS 1 KB5 30 minutes interval after 5 minutes mixing operation Heed warning notices As to KB 5 Maximum load capacity will not be reached during normal operation It is defined by 5 minutes mixing of pasta zinci in the UNGUATOR 100 ml jar at 2000 RPM and 30 minutes cooling interval A ...

Page 44: ...tom Polypropylene Polyethylene Jar bottom cap Polypropylene natural white white Further line items Spindle Polypropylene natural white Applicator long with cap Polypropylene natural white Applicator short with cap Polypropylene natural white Coupling Polypropylene natural white Varionozzle blue yellow pink Polypropylene natural blue yellow red SMB Polyoxymethylene white Disp Blade Polyamide white ...

Page 45: ...f UNGUATOR line products is exclusively made through wholesale firms that either have a marketing agreement with GAKO Konietzko GmbH or GAKO International GmbH In Germany the UNGUATOR line products are also directly marketed by GAKO Konietzko GmbH The General Delivery Terms either of GAKO Konietzko GmbH or GAKO International GmbH shall apply Customer Service Please contact the service department o...

Page 46: ...rzertifikat WARRANTY CERTIFICATE for the Date of purchase _________ Ser no ________ Stamp and signature SMS Elap GmbH Co KG Service Center UNGUATOR Am Köhlersgehäu 50 D 98544 Zella Mehlis Telephone 49 0 3682 455 199 Fax 49 0 3682 455 206 ...

Page 47: ...47 12 Dokumentationsblatt ...

Page 48: ...ion O Valuation OK O O O O PRE PRE 01 02 03 04 05 06 07 08 09 10 11 12 Final Q check 13 Mixing time 14 Rpm 15 Strokes 16 Preparation Mark ID number FSP NAME Remarks Calc Mixing data g ml No of programm Jar size Freespin program O Composition Q control pasting program Pregrind program Main mixing program Document template ...

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Page 52: ...GAKO International GmbH Dantestrasse 27 D 80637 München www unguator com T100A521 0708 ...

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