B. Braun Aquaboss CCS, Инструкция по эксплуатации

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Use in combination with other equipment
Section 1 – Operating Instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Chapter 4
Page 4-1
4. Use in combination with other equipment
The operator combines the CCS with further medical products such as loops, media supply units or
dialysis machines.
The CCS and medical products are placed on the market independently. No combination of medical
products will be put into circulation by the manufacturer as a standard variation.
The manufacturer, B. Braun Avitum AG, stipulates the following concentrate supply requirements for com-
bination with other equipment:
When used in combination with concentrate loops, these must be implemented in accordance with
DIN EN 793/VDE 0750-211 (medical electrical equipment, specific requirements for the safety of medical
supply units).
When used in combination with media supply units MPC, the tapping points for concentrate must be imple-
mented in accordance with DIN EN 11197 (VDE 0750-211), medical supply units.
Where in-house production of acid concentrates is carried out, the service life of the couplings used by
MPC can be restricted. In this case, B. Braun recommends the use of stainless steel coupling sets made of
seawater-proof material.
Dialysis units (Class IIb medical products) used in combination must comply with standard DIN / VDE 0753-4
[Guideline for the safe use of medical products in dialysis treatment]. Furthermore, the dialysis machine
must comply with standard IEC 60601-2-16 (equivalent to EN 60601-2-16: Particular requirements for the
basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equip-
ment) or the first issue of this standard IEC 60601-2-16.
ATTENTION The user must ensure that the devices function and are in the proper condition before using
the combination of devices.
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.
NOTE
The Aquaboss central concentrate supply is designed for safe operation in combination with
Aquaboss ®
products (ring leads, reverse osmosis system).
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.