WEPA TOPITEC AUTOMATIC Mode D'emploi page 89

4.3 Operating and maintenance personnel
Operating and maintenance personnel include all persons involved in the transportation, instal-
lation, operation and cleaning of the TOPITEC
tions, see page 18).
1. The TOPITEC AUTOMATIC must only be operated by suitably trained and authorised personnel.
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2. The device owner must ensure that there are clear instructions regarding the operation of
the TOPITEC AUTOMATIC in place, and that all personnel are aware of their responsibilities
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so as to avoid confusion that might result in a dangerous situation.
3. For all work with and on the device (operation, cleaning, maintenance, repair, etc.),
personnel must strictly adhered to the shut-down procedures described in this operating manual.
4. Operating personnel must refrain from any action that might compromise the safety of the
TOPITEC ® AUTOMATIC.
5. The device owner must take suitable measures to ensure that only authorised personnel
have access to the TOPITEC
6. Operating personnel are obliged to notify their supervisor without delay, if they observe any
changes to the TOPITEC
7. The device owner must ensure that the TOPITEC
proper working order.
8. Operating personnel must comply with all statutory regulations and observe the specific
instructions for the substances to be processed. 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.
9. The device owner must ensure that all personnel wear the required personal protective
equipment. Compliance must be monitored.
Danger
PPE:
Wear tight-fitting clothing, preferably without sleeves. Do not wear scarfs,
ties, necklaces, rings, etc. Cover your hair with a hairnet. Do not operate the
device with gloves, as there is a risk of entanglement at the shaft.
Wear safety goggles to protect your eyes against harmful substances from
ointments, creams, powders, etc. While the machine is in operation, do not
reach into its mechanical parts. Do not touch the shaft, as this could lead to
serious injury from crushing or shearing.
Moving the safety bracket (see also page 32) upwards leads to the device
shutting down. After an emergency-stop, the device must be restarted.
Information regarding proper hygiene procedures can be found in the Ap-
BetrO, the hygiene guidelines published by Gesellschaft für Dermopharmazie
GD for the preparation of non-sterile pharmaceutical products (known as GD
Hygiene Guidelines), the BAK Guidelines, statutory regulations, etc.
AUTOMATIC. (For responsibilities and authorisa-
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® AUTOMATIC.
AUTOMATIC that might compromise its safety.
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AUTOMATIC is always in
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