B. Braun Aquaboss CCS Instructions For Use Manual page 5

Notes on operating instructions
The operating instructions contain information regarding the safe use of the system.
The user must convince himself of the correct function and proper state of the medical product before put-
ting it to use, and heed the operating instructions and other information and maintenance instructions
enclosed.
The operator is to be instructed on the following points and committed to observe them:
• The user must undertake to operate the system only in proper condition. The system must not be
used or applied if there are any faults that could cause harm to patients, employees or third parties.
The user must ensure that the devices function and are in proper condition prior to any use.
• The operator is to be instructed on hazards, rules of behaviour and any safety measures necessary
when dealing with the substances used, instructed on what to do in the event of an emergency and
in first aid.
• The operator is to be instructed on the permissible operating data (e.g. setting data for safety and
monitoring systems, functional tests).
• The operator is to be instructed on system servicing, routine check and elimination or irregularities
in operation.
• The operator is to be instructed on safe procedures handling the products. This includes theoretical
principles, proper handling and conditions for application.
• Using instructions and tests, the operator must provide for cleanness and orderliness where the
product is used.
• The operator is obliged to regulate the responsibilities during commissioning, operation and servicing
quite clearly so that these are met by everyone, so that there is no confusion about expertise from
a safety point of view.
• The medical product may only be operated according to its intended purpose in accordance with the
regulations of the current German medical product operator ordinance.
• The medical product may only be set up, operated and used by people who have the required training
or knowledge and experience.
• The user is obliged to inform his superior/the operator immediately as to any changes on the system
that affect safety and to observe all the safety instructions.
Rev. 2.8 Date 2019-02-04
Software version 1.00
Notes on operating instructions
CCS