Use in combination with other equipment
Part 1 • Page 4-1
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Chapt
er 4
4.
Use in combination with other equipment
The operator combines the EcoRO Dia I/II (HT) with further medical devices such as loops, media supply
units or dialysis machines.
The EcoRO Dia I/II (HT) and further medical devices can be put into circulation independently of one
another. No combination of medical devices will be put into circulation by the manufacturer as a variation.
The manufacturer, Lauer Membran Wassertechnik GmbH, stipulates the following reverse osmosis system
requirements for combination with other equipment:
•
When used in combination with permeate loops, these must be implemented in accordance with
AAMI/ISO 23500:2009.
•
When used in combination with media supply units (Medical Product Class I), the tapping points for
permeate must be implemented in accordance with ISO 23500:2009.
•
Furthermore, the dialysis machine must comply with standard IEC 60601-2-16 (Special requirements
for the safety of haemodialysis, haemodiafiltrations and haemofiltration units) or the first issue of
standard IEC 60601-2-16.
IMPORTANT At the point of connection potable water a backflow prevention must be installed!
NOTICE
The operator must ensure that the devices function and are in the proper condition before
using the combination of devices.
NOTICE
It must be ensured that additional equipment that is connected to the analogue and digital
interfaces of the device satisfies the appropriate IEC specifications (e.g. IEC 60950 for data
processing devices, IEC 61010-1 for measuring/control/laboratory devices and IEC 60601-1
for electro-medical devices). Furthermore, all configuration must satisfy the valid version of
IEC 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 IEC 60601-1-1 is observed. If you have any questions, please
contact your local dealer of the Technical Services department.
