B. Braun Aquaboss CCS, Инструкция по эксплуатации

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Area of application and intended use
Section 1 – Operating Instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Chapter 2
Page 2-1
2. Area of application and intended use
The operator is responsible for the proper operation of the system.
The
Aquaboss
Central Concentrate Supply CCS may only be used for the intended purpose and is
designed for a lifetime of 10 years.
2.1 Operational features
The central concentrate supply pumps up to 3 different acid hemodialysis concentrates on up to two floors.
The pumps are speed-regulated in order to meet the maximum pressure requirements at the point of
transition specified by the manufacturer.
2.2 Important performance features
Pumping of acid hemodialysis concentrates to the user without having a negative influence on their
physical, chemical or micro-biological characteristics.
The Aquaboss central concentrate supply has a short period of application as per the 93/42/EEC
Appendix IX Directive (<30 days).
2.3 Application regulations
Only liquid, acid hemodialysis concentrates (acid concentrate, A-concentrate ISO 13958) may be pumped.
• Intended use also includes observance of the commissioning, operating and maintenance instructions
provided by the manufacturer, which are an integral part of these instructions.
• The system may only be transported, installed, used and repaired by skilled workers.
• Commissioning, operation and routine check is only to be carried out by authorized, trained and
instructed skilled workers.
• Any other use of the system is considered as non-intended use. The manufacturer shall not be liable
for any damage resulting from this.
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 6.2.3.
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.
CAUTION
The concentrates to be pumped must be free of crystalline soiling and precipitates.