WEPA TOPITEC 026620, Руководство пользователя

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11
DEVICE COMPONENTS
AND PROPER USE
2.2. Proper use / product description
• The TOPITEC ® TOUCH is used for the production of semi-solid formulations in pharmacies
(medicines, ointments, creams, cosmetic products). 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 ® TOUCH has been developed and designed for commercial applications exclu-
sively. Any private use of the TOPITEC ® TOUCH is forbidden.
• The TOPITEC
®
TOUCH is not designed for operation in potentially explosive atmospheres
(vapour or dust; ATEX; observe information in safety data sheets) 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 fully qualified adult pharmaceutical
specialist who has received special instruction and training for this specific task. 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 pub-
lished by Gesellschaft für Dermopharmazie GD for the preparation of non-sterile pharmaceutical
products, the BAK Guidelines, statutory regulations, etc.
Warning
The mixing system must only be used for the purpose shown above. Any other form of
use which goes beyond this or any modification of the mixing system without the written
agreement of the manufacturer is deemed inappropriate. The manufacturer shall not be
liable for any damage arising from improper use or unauthorised modifications. The risk
is borne by the operator alone. The mixing system may only be commissioned once it has
been ensured that all safety devices have been installed and are fully functional.
Danger
Products which can give off explosive dust/air mixtures must not be processed with this
mixing system! The mixing system does not meet ATEX standards! The TOPITEC
®
TOUCH
is not designed for operation in potentially explosive atmospheres.
Proper use of the equipment includes strict compliance with the operating, maintenance and
repair instructions of the manufacturer.
The projected service life of the mixing system is approx. 10 years. A complete service by an
authorised specialist firm is then necessary.