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WEPA TOPITEC EXPERT User Manual

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Summary of Contents for WEPA TOPITEC EXPERT

  • Page 1 expert USER MANUAL...

  • Page 2: Declaration Of Conformity

    DECLARATION OF CONFORMITY In accordance with • EC Machinery Directive 2006/42/EC • EU Low Voltage Directive 2014/35/EU • EU EMC Directive 2014/30/EU We herewith declare that the design of product: TOPITEC ® EXPERT S/N; machine no. XXXXXX as brought onto the market by us conforms to the DIN EN standards listed below.
  • Page 3 COPYRIGHT The copyright in this document is owned by WEPA Apothekenbedarf GmbH & Co KG. The reproduction or disclosure of the content of this user manual, in any format whatsoever, is only permitted with the prior written consent of WEPA Apothekenbedarf GmbH & Co KG. WEPA Apothekenbedarf GmbH &...
  • Page 4 TOPITEC ® EXPERT User Manual | 11-2018...
  • Page 6 TOPITEC ® EXPERT User Manual | 11-2018...
  • Page 7 INTRODUCTION The production of preparations by pharmacists for the treatment of dermatological disorders is bound to remain an important element of drug treatment. In this context, the preparation of medicine for external application plays an important role. The move from manual grinding with mortar and pestle to semi-automated and automated production methods offers many advantages as regards the quality and the safety of pharmaceutical products.

  • Page 8: Customer Service

    CUSTOMER SERVICE The TOPITEC Competence Centre is there to assist you. ® News and tips The latest information and many useful tips in connection with the production of medicines with the TOPITEC ® mixing system are published on our website at www.topitec.de. Please visit our website and share your experiences with the device with other users! Galenic queries concerning TOPITEC equipment...
  • Page 9 2. DEVICE COMPONENTS AND PROPER USE 2.1 Diagram of TOPITEC EXPERT ® The TOPITEC ® EXPERT consists of the following main components: 1. Housing 2. Touch screen 3. Tool shaft adapter (concealed) with safety bracket 4. Locking device with securing bracket 5.
  • Page 10 (tool shaft). The preparation of the product (adding ingredients in the correct sequence to the jar) takes place outside the device. Professional instruction by WEPA or WEPA sales partner. • The TOPITEC EXPERT has been developed and designed exclusively for commercial ®...
  • Page 11 Proper use of the equipment includes strict compliance with the operating, maintenance and repair instructions of the manufacturer. Warning The mixing system must only be used for the purposes listed above. Any other use is deemed improper and is thus prohibited. The mixing system must not be modified in any way, unless written consent has been obtained from the manufacturer.

  • Page 12: Product-Specific Data

    2.3 Technical data 2.3.1 Product-specific data Jar sizes: Jars up to max. diameter 118 mm Single-patient containers, single-patient jars, jars for stock preparation 2.3.2 Dimensions and weight TOPITEC EXPERT (device dimensions) including touch screen ® Width: approx. 286 mm Depth: approx.

  • Page 13: Noise Emission

    2.3.4 Load on table top Weight including all media: Static load: approx. 184 N (approx. 18.8 kg) Static + dynamic load: approx. 185 N (approx. 19 kg) 2.3.5 General data Operating temperature range: Lower limit temperature: + 15 °C Upper limit temperature: + 35 °C Air humidity: 40%, short-term max.
  • Page 14 3. SAFETY 3.1 Safety instructions and notes Danger "DANGER" highlights dangerous situations. Such situations must be avoided! Non-compliance with the instructions might result in serious or even fatal injury. Warning "WARNING" highlights potentially dangerous situations. Such situations must be avoided! Non-compliance with the instructions might result in serious or even fatal injury.
  • Page 15 3.1.1 Safety symbols in this document Danger Danger from electric current Danger Danger from running machine (entanglement, crushing) Danger Risk of crushing, injury to hands Warning When working in areas labelled with this symbol, wear suitable protective gloves. Warning When working in areas labelled with this symbol, wear suitable protective clothing.

  • Page 16: Device Type / Identification

    Note This symbol indicates the connecting points of the protective earth conductor. Note This symbol highlights instructions relating to the protection of the environ- ment. 3.1.2 Device type / identification Note The information in this operating manual applies only to devices bearing the type number printed on the cover page.
  • Page 17 3.2 Built-in safety systems The built-in safety devices must be regularly checked and tested by an electrician as described in the table below. Interval Method V = visual inspection a = annually F = function test M = measurement Table 1 Test intervals for safety systems 1.
  • Page 18 Danger The TOPITEC EXPERT contains internal components that are electrically ® powered. Its internal parts do not need to be serviced and there is no need to open the housing of the device! Should it be necessary to open the housing of the TOPITEC®...
  • Page 19 3.3 Interfaces of TOPITEC EXPERT ® Description of TOPITEC ® EXPERT control elements for operating personnel; power connections and data interfaces. 6. 7. Fig. 3-3 Interfaces of TOPITEC EXPERT ® The TOPITEC EXPERT is equipped with the following interfaces: ® 1.
  • Page 20 3.4 Safety precautions (to be implemented by device owner) Please note that the device owner is responsible for the proper instruction of all operating and maintenance personnel as regards: • the safety devices of the TOPITEC ® EXPERT; • compliance with all safety instructions in this manual. Compliance must be monitored.
  • Page 21 3.5 Duties of device owner Note In EFTA countries, the relevant national regulations based on framework directive 89/391/EEC and the associated specific directives, in particular 2009/104/EC regarding the minimum health and safety precautions in connection with the operation of equipment by employees, as amended, apply and must be strictly adhered to.
  • Page 22 The device owner must • provide suitable safety equipment such as hand-held fire extinguishers in the required quantity and of suitable size and type at easily accessible locations near the device; • protect the TOPITEC ® EXPERT through a potential equalisation system that conforms to the statutory requirements (in Germany Ordinance on Industrial Safety and Health);...
  • Page 23 3.6 Safety tests performed at the factory by the device manufacturer 1. Risk analysis based on Machinery Directive 2006/42/EC (Annex I) and DIN EN ISO 12100:2011. 2. Sound pressure measurement (no report required, as LPA < 70 dB(A)) according to Machinery Directive, Annex I 3.

  • Page 24: General Safety Instructions

    4. GENERAL SAFETY INSTRUCTIONS 4.1 Dangers Observe the information regarding the safety systems, and the safety notes in this operating manual. The device is controlled through the touch screen. During operation, keep the area around the TOPITEC EXPERT free of clutter to ensure unobstructed access to the control elements. ®...
  • Page 25 4.3 Operating and maintenance personnel Operating and maintenance personnel include all persons involved in the transportation, installation, operation, troubleshooting and cleaning of the TOPITEC EXPERT. ® (For responsibilities and authorisations, see page 20). 1. The TOPITEC EXPERT must only be operated by suitably trained and authorised personnel. ®...
  • Page 26 Do not start the mixing system before you have assured yourself that all safety devices are working properly. Customer service For spare part orders, contact: WEPA Apothekenbedarf GmbH & Co KG Am Fichtenstrauch 6–10, D-56204 Hillscheid, Germany P +49 (0)2624 107-0, F +49 (0)2624 107-444 info@wepa-apothekenbedarf.de, www.wepa-dieapothekenmarke.de TOPITEC ®...

  • Page 27: Shutdown Procedure

    4.5 Shut-down procedure Danger Prior to any cleaning, maintenance or repair tasks (to be performed by an electrician), shut down the device as described below: 1. Lower the slide to its initial position and remove the jar. 2. Disconnect the TOPITEC EXPERT from the power supply: ®...
  • Page 28 5. STANDARD EQUIPMENT / INSTALLATION / COMMISSIONING 5.1 Scope of delivery of TOPITEC EXPERT ® The delivery includes: 1. TOPITEC EXPERT ® 2. Operating manual 3. Standard equipment Fig. 5-1 Scope of delivery of TOPITEC ® EXPERT TOPITEC ® EXPERT User Manual | 11-2018...

  • Page 29: Standard Equipment

    5.2 Standard equipment The TOPITEC EXPERT ® is available in two versions Order no. 026720 - housing colour pearl night blue Order no. 026721 - housing colour pearl white Power cable, order no. 080850 Fig. 5-2 TOPITEC EXPERT models ® TOPITEC holder for jar 20/30 g (2017) ®...

  • Page 30: Installation

    5.3 Installation 5.3.1 Transport and packaging All mixing systems are carefully inspected before they are packed. However, the equipment might become damaged during transport. 5.3.1.1 Delivery (also for spare and replacement parts) Incoming inspection • Upon receipt of the delivery, check the goods for completeness, referring to the delivery docket! In the event of damage: •...
  • Page 31 5.3.1.2 Temporary storage The transport packaging of the mixing system and spare parts is designed for storage for maximum 3 months. Note Store the TOPITEC EXPERT in a dry room. ® Storage conditions: • See chapter 2.3.5 "Technical data". Warning Never clean the TOPITEC ®...
  • Page 32 5.6 Commissioning 5.6.1 Start-up Remove all packaging and protective material and position the TOPITEC EXPERT on the worktop ® (see chapter 5.3.1.1). The TOPITEC ® EXPERT must be placed on a level and firm surface. When choosing the location of installation, observe the information on page 31. The TOPITEC EXPERT is not designed for operation in potentially explosive atmospheres.

  • Page 33: Operation

    6. OPERATION Warning The TOPITEC ® EXPERT must only be operated by instructed personnel who have been trained in its functions and control. Note Before starting production, ensure that there are no objects (e.g. tools, residual material, etc.) on or near the TOPITEC EXPERT mixing system.
  • Page 34 6.2 Safety bracket When the safety bracket is touched, the mixing system is instantly stopped. The safety bracket prevents injury from being caught between the tool shaft adapter and the jar during production. If the safety bracket is pushed up while the slide is moving upwards, the mixing process is immediately stopped.
  • Page 35 6.3 Control elements of TOPITEC EXPERT ® Housing Camera (concealed) Tool shaft adapter (concealed) with safety bracket Locking device with securing bracket TOPITEC ® jar holder 20-30 g or 50-200 g (detachable) TOPITEC base ring for ® single-patient jars / jars for stock preparation USB port (A+B) for maintenance, PC or...

  • Page 36: Automatic Mode

    The TOPITEC EXPERT mixing system is controlled through the touch screen, ® which features a number of icons and function buttons. Do not apply force when touching the touch screen surface. If the touch screen buttons are touched with an implement, the screen might become dirty or damaged.
  • Page 37 6.4.4 Operation Warning • Before starting the device, check the power cable and the main switch for proper connection/functioning. • Switch on the main switch. The device starts up. • The TOPITEC ® EXPERT mixing system is controlled through the touch screen.
  • Page 38 7. PRICING 7.1 aponorm packaging units for TOPITEC mixing systems ® ® The latest edition of the "Hilfstaxe für Apotheken" that applies in Germany contains the agreed prices for the aponorm jars with metering bottom (TOPITEC jars). For your convenience, the ®...
  • Page 39 aponorm single-patient jars (TOPITEC single-patient jars) ® ® Order no. Colour/design Capacity PZN (1 unit) (quant.) 035260 red/white 300 g / 408 ml 0775379 035261 red/white 500 g / 690 ml 0775416 aponorm jars for stock preparation ® (TOPITEC jars for stock preparation) ®...
  • Page 40 8. ACCESSORIES FOR TOPITEC EXPERT ® 8.1 aponorm jars (TOPITEC jars) ® ® Receipt book, incl. TOPITEC jars ® Use instructions Order no. 038053 aponorm single-patient jars (TOPITEC single-patient jars) ® ® made in polypropylene (a product of the aponorm ®...
  • Page 41 aponorm jar for stock preparation ® (TOPITEC jar for stock preparation) ® for the production and storage of semi-solid formulations produced with a TOPITEC AUTOMATIC II, TOUCH or EXPERT ® mixing system. Size 1,000 g, capacity 1,260 ml, dimensions 128 x 123 mm (H x outer Ø), container in white PE, with red PP screw lid, with seal ring of originality and aponorm ®...
  • Page 42 Tool shaft with titanium-nitride (TiN) alloy coating, in storage box Order no. 025680 TOPITEC jar holder (size 1) ® for TOPITEC jar sizes 20 g and 30 g ® Order no. 025699 TOPITEC jar holder (size 2) ® for TOPITEC jar sizes 50 g to 200 g ®...
  • Page 43 Single-patient jar (complete) Consisting of a production container made in white POM and a white POM filling plunger with mounted stainless steel M9 threaded adapter for filling tubes or threaded tube heads. Sterilisable, in storage box (order no. 085500) and user instructions (order no. 080897) Size 50 g: Order no.
  • Page 44 9. MAINTENANCE / CLEANING / INSPECTION INTERVALS & FUNCTION TESTING Warning Chapter "Maintenance / cleaning / inspection intervals & function testing" contains important information for • maintenance and repair work, and tests to be performed by electricians at the prescribed inspection intervals. •...
  • Page 45 Protect the device against mechanical impact! Do not drop the device or any of its accessories. When moving the device on the worktop, ensure that no electronic or mechanical components are damaged. Protect the device against dust! Install and store the system and its accessories in a dust-free environment, as fine particles could damage moving parts! Protect the device against high temperature! Do not install or store the system or its accessories in a room where they are exposed to high...
  • Page 46 Cleaning of housing and base Do not use pointed implements or aggressive detergents. Clean the housing and the device base with a moist, soft cloth and a mild soapy solution. Alternatively, use a alcohol/water mixture. To prevent residue, we recommend wiping the device dry with a soft cloth. Before cleaning the device, disconnect the power plug from the socket! Cleaning of touch screen To clean the touch screen, use only a dry cleaning cloth.
  • Page 47 • Correct maintenance at the prescribed intervals is a prerequisite for trouble-free operation of the mixing system. The maintenance intervals in this manual are based on information provided by the manufacturers of third-party components and the experience of WEPA Apothekenbedarf GmbH & Co KG. 9.1.2 Inspection •...
  • Page 48 9.3 Inspection intervals – function testing To ensure trouble-free and safe operation of your TOPITEC ® EXPERT mixing system, it must be regularly inspected for damage. Also, its switches and buttons must be checked at regular intervals for proper functioning. With one-shift operation, perform a function test of all switches and buttons every three months.

  • Page 49: Warranty And Liability

    9.5 Warranty and liability WEPA Apothekenbedarf GmbH & Co KG (hereafter referred to as "the Manufacturer") grants the end customer (hereafter referred to as "the Customer") based in ... a 3-year warranty from the date of delivery on the TOPITEC ®...

  • Page 50: Troubleshooting

    10. TROUBLESHOOTING 10.1 Practical tips – instant remedy! Tool shaft fails to engage: Check the position of the mixing container or jar in the clamping ring and reposition the container or jar in the ring. Danger Before carrying out any maintenance or repair work, shut down the device, following the proper shut-down procedure (see chapter 4.5).

  • Page 51: Emergency Stop

    11. EMERGENCY-STOP In the event of an emergency, press the "Cancel" button or shut down the device at the main switch and disconnect the power cable.
  • Page 52 12. DISPOSAL Disposal The system, except for the electronic equipment, is mainly made from steel, with some parts in aluminium. Dispose of it through recycling according to the applicable statutory waste disposal regulations. These regulations are likely to require the separate handling and disposal of •...
  • Page 54 13. INDEX Power supply Pricing 38-39 Technical data TOPITEC jars / aponorm jars 40-41 ® ® Touch screen 9, 19, 46 Type plate 9, 19 Diagram of TOPITEC EXPERT ® Maintenance Tool shaft 42, 50 Accessories 40-43 TOPITEC ® EXPERT User Manual | 11-2018...
  • Page 55 14. NOTES...
  • Page 56 WEPA Apothekenbedarf GmbH & Co KG, D-56204 Hillscheid, Germany P +49 (0)2624 107-361, F +49 (0)800 5252500 (Bestell-Fax, gebührenfrei) info@wepa-apothekenbedarf.de, www.wepa-dieapothekenmarke.de...

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