WEPA TOPITEC EXPERT Bedienungsanleitung
USER MANUAL
expert
2
TOPITEC ®EXPERT User Manual | 11-2018
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. Harmonised standards:
Directive / standard Title
2014/30/EU EU Directive: EMC Directive valid from 01/04/2016
DIN EN 61000-6-3: 2011-09 Electromagnetic compatibility, emission standard –
light industry
DIN EN 61000-6-2: 2006-03 Electromagnetic compatibility, immunity standard –
light industry
2014/35/EU
EU Directive: Low Voltage Directive valid from 01/04/2016
DIN EN 61010-1:2011
Safety requirements for electrical equipment for measurement,
control,
and laboratory use – Part 1: General requirements
2006/42/EC EC Directive: Machinery Directive valid from 29/12/2009
DIN EN ISO 12100:2011 Safety of machinery – General principles for design –
Risk assessment and risk reduction
DIN EN 349 :2008 Safety of machinery – Minimum gaps to avoid
crushing of parts of the human body
• This Declaration applies exclusively to the product as delivered.
• The basic requirements as regards health and safety as laid down in Annex I
of Machinery Directive 2006/42/EC are fully complied with.
• The special technical documentation according to Annex VII A has been compiled and shall be
made available in electronic format to the relevant state authorities on request.
3
DECLARATION OF CONFORMITY / TRANSLATION / COPYRIGHT
TRANSLATION
Machines shipped to EFTA countries are accompanied by a translation of the operating
instructions into the respective language. In the event of discrepancies between the translation
and the original (German) version of the manual, the German version is deemed valid. If you
have any queries, contact the manufacturer.
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 & Co KG shall not be liable for damage caused in connection with the
use of this manual.
Reproduction of this document, its use and the communication of its content to a third party
are only permitted with the express consent of WEPA Apothekenbedarf GmbH & Co KG. Any
breach will result in legal action for damages. All rights reserved.
2nd edition: November 2018 © Copyright 2018
WEPA Apothekenbedarf GmbH & Co KG
Am Fichtenstrauch 6–10, D56204 Hillscheid, Germany
P +49 (0)2624 107-0, F +49 (0)2624 107-444
[email protected], www.wepa-dieapothekenmarke.de
Note
This operating manual is an integral part of the scope of delivery of the
mixing system. A copy of this manual must be accessible at all times to
operating and maintenance personnel. All safety instructions in this
manual must be strictly adhered to. When elling the product, the
operating manual must be handed over to the new owner.
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TOPITEC ®EXPERT User Manual | 11-2018
TABLE OF CONTENTS
1 Content
1.1 Table of contents 4-5
1.2 List of figures 6
1.3 Content 6
1.4 Introduction 7
1.5 Service 8
2 Device diagram and proper use 9
2.1 Diagram of TOPITEC®EXPERT 9
2.2. Proper use 10-11
2.3 Technical data 12-13
3 Safety 14
3.1 Safety instructions and notes 14-16
3.2 Built-in safety systems 17-18
3.3 Interfaces of mixing system 19
3.4 Safety precautions (to be implemented by device owner) 20
3.5 Duties of device owner 21-22
3.6 Safety tests 23
3.7 Safety checks 23
4. General safety instructions 24
4.1 Dangers 24
4.2 Danger areas of TOPITEC®EXPERT mixing system 24
4.3 Operating and maintenance personnel 25
4.4 Replacement of parts 26
4.5 Shut-down procedure 27
5 Standard equipment 28
5.1 Scope of delivery 28
5.2 Standard equipment 29
5.3 Installation 30-31
5.4 Transport 31
5.5 Installation and assembly 31
5.6 Commissioning 32
5
TABLE OF CONTENTS
TABLE OF CONTENTS
6 Operation 33
6.1 Connection to power supply, interfaces 33
6.2 Installation 34
6.3 Control elements of TOPITEC®EXPERT 35
6.4 Operating modes and control 36-37
7 Pricing 38-39
8 Accessories of TOPITEC®EXPERT 40-43
9 Maintenance / cleaning / inspection intervals & function testing 44-46
9.1 Maintenance 47
9.2 Cleaning 47
9.3 Inspection intervals – function testing 48
9.4 Warning signs attached to TOPITEC®EXPERT 48
9.5 Warranty and liability 49
10 Troubleshooting 50
10.1 Practical tips – instant remedy 50
11 Emergency-stop 51
12 Disposal 52
13 Index 53-54
14 Notes 55
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TOPITEC ®EXPERT User Manual | 11-2018
TABLE OF CONTENTS
1.3 List of tables
Table 1 Test intervals for safety systems 17
Table 2 Weights of transport units 31
Table 3 Warning signs attached to TOPITEC®EXPERT 48
Table 4 Troubleshooting 50
TABLE OF CONTENTS
1.2 List of figures
Fig. 2-1 Diagram of TOPITEC®EXPERT 9
Fig. 3-3 Interfaces of TOPITEC®EXPERT 19
Fig. 5-1 Scope of delivery of TOPITEC®EXPERT 28
Fig. 5-2 Control elements of TOPITEC®EXPERT 29
Fig. 6-1 Power connection, interfaces 33
Fig. 6-3 Control elements of TOPITEC®EXPERT 35
Fig. 7-1 aponorm®packaging units for TOPITEC®mixing systems 38-39
Fig. 8-1 Accessories of TOPITEC®EXPERT 40-41
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TABLE OF CONTENTS / INTRODUCTION
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.
With the innovative TOPITEC®EXPERT, you now have the option to perform many different
mixing processes and to store relevant parameters so that they can be called up at any time for
other batches.
Whether you use the TOPITEC®jar to mix ingredients for a single batch or work with the larger
stock preparation container available as an optional accessory: the TOPITEC®EXPERT can save
your settings and formulations, if that is useful to you.
With the optional TOPITEC®DokuManager software, you even have the option to connect the
multi-talented mixing device to your PC, bringing together drug formulation and quality
assurance.
All patient-specific prescriptions, formulations and stock preparations can thus be
documented in a single system.
To talk to our customer support specialists, call: Phone +49 (0)2624 107-145
Phone +49 (0)2624 107-146
www.topitec.de
Your
TOPITEC® Service Centre
Competence Team
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TOPITEC ®EXPERT User Manual | 11-2018
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
Our qualified pharmaceutical specialists assist you in all matters regarding formulations and
applications that might arise in the use of your TOPITEC®mixing system.
Technical support for TOPITEC®equipment
For technical support, contact our team of experts by telephone. In Germany, we operate a
technical call-out service.
Training
We assist professional associations in devising training courses to ensure that pharmacists and
other specialists are kept informed of the latest developments in the field.
9
SERVICE / DEVICE COMPONENTS AND PROPER USE
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. TOPITEC®jar holder 20-30 g or 50-200 g (detachable)
6. TOPITEC®base ring for single-patient jars / jars for stock preparation
7. Type plate
8. USB port (A+B) for maintenance, PC or peripheral connection
9. LAN connection
10. Power switch with fuse holder and power cable port
11. Camera (concealed)
Fig. 2-1 Diagram of TOPITEC®EXPERT
1.
2.
3.
4.
5./6.
7.
8./9.
10.
11.
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TOPITEC ®EXPERT User Manual | 11-2018
2.2. Proper use / product description
•
The TOPITEC®
EXPERT is designed for the production of semi-solid formulations (medicines,
ointments, creams, cosmetic products) in pharmacies.
During production, the jar containing the ingredients is moved up and down while the product
inside the jar is stirred by means of the mixer (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
applications. Any private use of the TOPITEC®EXPERT is forbidden.
• The TOPITEC®EXPERT is not designed for operation in potentially explosive atmospheres
(vapour or dust; ATEX; observe information in safety data sheet) or within a designated ATEX
zone as defined by the device owner.
2.2.1. Proper use / application
Mixing of prepared and sealed jars containing pH neutral pastes, ointments, creams or powders
that are not radioactive, explosive or flammable. The device is designed for use in pharmacies and
operation by suitably instructed personnel. The mixing of ingredients must not result in explosive
substances.
An instructed person (operator) is a person with a pharmaceutical qualification who is older than
18 years of age and has been instructed in the use of the device.
The substances, materials and media to be used for processing in the mixing system are to be
sourced by the device owner, who is responsible for the proper use of these substances. The device
owner is also responsible for the correct handling of these substances, materials and media,
with due regard to any associated risks. The device owner must provide safety and disposal
instructions for staff. Strictly observe the safety data sheets provided by the manufacturers of the
materials / media.
For safety and quality reasons, the device must only be used in conjunction with original
TOPITEC®/aponorm®containers. These containers are not gas-tight, so substances might leak out.
The device owner must ensure that all personnel wear the required personal protective
equipment. Compliance must be monitored.
Operating personnel must comply with all statutory regulations and observe the specific
requirements for the processed substances.
Information regarding proper hygiene procedures can be found in the ApBetrO, the hygiene
guidelines published by Gesellschaft für Dermopharmazie GD for the preparation of sterile
pharmaceutical products, the BAK Guidelines, statutory regulations, etc.
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