25
GENERAL SAFETY INSTRUCTIONS
4.3 Operating and maintenance personnel
Operating and maintenance personnel are people who are responsible for the transport, operation and
cleaning of the TOPITEC
®
Touch and also for the troubleshooting. (For responsibilities and authorisations,
see page 20).
1. The TOPITEC
®
TOUCH must only be operated by suitably trained and authorised personnel.
2. The device operator is obliged to ensure that there are clear instructions regarding the operation of
the TOPITEC
®
Touch in place, and that all personnel are aware of their responsibilities 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 adhere 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
®
Touch.
5. The device operator must take suitable measures to ensure that only authorised personnel
have access to the TOPITEC
®
Touch.
6. Operating personnel are obliged to notify their supervisor without delay, if they observe any changes
to the TOPITEC
®
Touch
that might compromise its safety.
7. Operating personnel must ensure that the TOPITEC
®
Touch is always in proper working order.
8. 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 non-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 scarves, 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 35) 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 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.
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