Rev. 2.8 Date 2019-02-04
Software version 1.00
Page 1-2
CCS
Chapter 1
Safety
Section 1 – Operating Instructions
1.2.3
Risks due to non-observance of safety instructions
Non-observance of safety instructions can lead to danger for the user and/or the patient. Non-observance
can lead to the following dangers, for example:
•
Failure of important system functions
•
Failure of prescribed maintenance methods
•
Danger to persons through electrical and mechanical means
1.2.4
Impermissible operating modes
The operational safety of the system delivered is only guaranteed when the system is used for the
intended purpose. The values specified in the technical data must be kept, limit values must never
be exceeded.
1.3
Microbiological safety
Acid concentrates have a low risk of contamination. Nevertheless, connection between the devices
and the central concentrate supply must be made under defined hygienic conditions and be described
in the hygiene plan.
When central concentrate systems are used (acid concentrates), examination of the system for the
presence of fungi/micro-organisms is recommended once a year. If fungi/micro-organisms are found,
B. Braun recommends consultation with the manufacturer to agree further measures.
1.4
Residual risks
Residual risks are potential hazards which are not apparent, e.g.:
•
Hazard that could arise from the product or medium, such as allergies or skin irritations.
•
Hazard arising from faults in the control.
•
Hazard arising from misconduct of the operator
1. Electric shock
The concentrate supply system CCS is operated with an electric voltage of 100–240 V.
Improper opening of the control cabinet or damage to the electrical supply cables can trigger an
electric shock (danger to life!).
Any work at the system that requires opening of the control cabinet or touching the connection cables,
must only be carried out when the system is switched off (main switch to "0") and with the mains power
disconnected.
If the CCS is equipped with a fixed connection, the upstream disconnection mechanism must be used
to completely separate the system from the mains power.. Supply cables, terminals and mains filter
against electromagnetic interference are installed upstream of the mains switch (1) of the CCS.
2. Leakage
In case of leakage acidic haemodialysis concentrate may escape. There is the risk of skin irrigations
and chemical burns caused by acidic haemodialysis concentrate.
1.5
Cleaning
•
Cleaning with usual commercial surfactant cleaners and with water
•
Loosen concentrate remnants with water
•
The surfaces can be cleaned and disinfected with normal surface disinfectants
•
Do not use any solvent-containing cleaners
NOTE
Residual risks remain despite the measures taken to avoid such risks.
