B. Braun Aquaboss CCS, Инструкция по эксплуатации

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Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Notes on operating instructions
ATTENTION It must be ensured that additional equipment that is connected to the analogue and digital
interfaces of the device satisfies the appropriate EN specifications (e.g. EN 60950 for data
processing devices, EN 61010-1 for measuring/control/laboratory devices and EN 60601-1
for electro-medical devices). Furthermore, all configuration must satisfy the valid version of
EN 60601-1-1. The person who connects additional equipment to the signal input or output
sections is a system configurator and is therefore responsible for ensuring that the valid
version of system standard EN 60601-1-1 is observed. If you have any questions, please
contact your local dealer of the Technical Services department.
ATTENTION Medical devices which are directly or indirectly connected (ring leads, haemodialysis
devices) must be secure against 5 bars pressure.
ATTENTION
The choice of concentrate mixing equipment for dialysis is the responsibility of the dialysis
physician.
To prevent idling of the connected ring piping, a check valve must be installed either in the
concentrate mixing system or in the ring piping.
ATTENTION The input of incorrect values may impair the proper functioning of the control or the
operational safety of the system.
Settings must be carried out only by authorised technical staff.
ATTENTION During venting, the pressure in the supply line can move above the normal operating
pressure. To protect any pressure devices connected from possible damage, they have to
be disconnected before venting.
ATTENTION Care must be taken that the hydraulic part of the system can be installed under the minimum
tank level.
ATTENTION The CCS is an electrical medical device. Special EMC safety measures are necessary and
the system must be installed in line with the EMC information provided in this instruction
booklet.
NOTE
Only original parts from B. Braun may be used. B. Braun does not accept any liability for
damage caused by spare parts, consumables or accessories that are not original B. Braun
parts.
NOTE
Residual risks remain despite the measures taken to avoid such risks.
NOTE
The intended use is the pumping and distribution of liquid acid hemodialysis concentrates.
NOTE
The devices of the CCS series are medical electrical equipment which is subject to special
safety measures with regard to EMC and must be installed and put into operation in
accordance with the instructions in Section 2, Chapter 6.
Portable and mobile HF communication equipment can influence medical electrical
equipment.
The devices of the CCS series must not be stacked or used directly next to or with other
devices. If this is necessary, the equipment must be observed in order to check proper
operation in this arrangement.
NOTE
The Aquaboss central concentrate supply is designed for safe operation in combination with
Aquaboss ®
products (ring leads, reverse osmosis system).