TOPITEC EXPERT Instrucciones De Uso página 81

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
(For responsibilities and authorisations, see page 20).
1. The TOPITEC EXPERT 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 EXPERT in place, and that all personnel are aware of their responsibilities so
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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 EXPERT.
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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
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.
To shut down the device in an emergency, actuate the safety bracket (see
page 34). After an emergency-stop, the device must be restarted.
Information regarding proper hygiene procedures can be found in the
ApBetrO, 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.
EXPERT.
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EXPERT that might compromise its safety.
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EXPERT.
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EXPERT is always in proper working order.
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