WEPA TOPITEC 026620, User Manual

Page: 105 / 588

21
SAFETY
3.5 Duties of device owner
Note
In EFTA countries, the relevant national regulations
based on framework directive 89/391/EEC
and the associated specific directives, in particular 2009/104/EC
regarding the minimum health and safety precautions in connection
with the operation of equipment by employees, as amended,
apply and must be strictly adhered to.
In Germany, the Ordinance on Industrial Health and Safety of 03/02/2015
(BetrSichV) must be observed (implementation of the above directive in
national law). Also observe the German Ordinance on the Operation of
Pharmacies ApBetrO and the BAK Guidelines.
The device owner is responsible for compliance with all relevant statutory regulations in
connection with
• occupational health and safety (accident prevention regulations, etc.), for example by devising
internal operating instructions, providing personal protective equipment (PPE) and arranging
for preventive check-ups;
• the safety of the equipment (e.g. protective equipment, work instructions, process risk
assessments, and maintenance schedules);
• the handling of hazardous substances
• the procurement of materials (material safety data sheets, hazardous substances lists);
• product disposal (waste disposal regulations);
• the disposal of the device (decommissioning, waste disposal regulations);
• cleaning (cleaning agents and their disposal);
• the protection of the environment;
• compliance with the ApBetrO, the guidelines published by the German Federal Chamber of
Pharmacists BAK, known as the BAK Guidelines, and all other relevant statutory regulations.
The device owner is also obliged to
• provide and regularly check the personal protective equipment (PPE):
Work coats, safety gloves (not for working on the Topitec
®
Touch), safety goggles, cap,
hair net, ...
• carry out regular risk assessments of the individual workplaces, hazardous substances
and fire risks.
• issue binding operating instructions and train personnel in the safe operation of the device
(training of operating personnel);
• issue work instructions for staff;
• enforce strict rules to ensure that personnel do not operate the device under the influence
of alcohol or other drugs, or when extremely tired;
• implement procedures that ensure that any safety-relevant faults of the device or its
components are reported without delay to the supervisor;
• devise a skin protection and hygiene plan.