Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
Notes on operating instructions
The operating instructions contain information regarding the safe use of the system.
Before a medical device can be used, the operator must be convinced of the functionality and the proper state of the
medical device; furthermore, he must heed the operating instructions as well as other safety-related information and
notes regarding operation provided with the operating instructions.
These are binding instructions issued by the manufacturer under his rights to publish such directives. As far as the
accident prevention regulations are concerned the operator is committed to observe such regulations.
National and local regulations for environmental protection must also be observed as well as the operating instruc-
tions to hand.
The operator is to be instructed on the following points and committed to observe them:
•
The operator is committed to only operate the system in perfect working order.
•
The operator must be instructed as to the risks, reactions and necessary protective measures that must be
taken when handling the materials being used and be trained to react properly in the event of danger and
provide first aid.
•
The operator is to be instructed on the permissible operating data (e.g. setting data for safety and monitoring
facilities).
•
The operator is to be instructed on system servicing, maintenance and elimination or irregularities in operation.
•
The operator is to be instructed on safe procedures using the products.
•
Using instructions and tests, the operator must provide for cleanness and orderliness where the product is used.
•
The operator must fulfill his obligation to regulate who is responsible for commissioning, operating, maintaining
and servicing the system to ensure that such work is carried out by all the persons involved without any
misunderstandings as to who is competent where safety aspects are concerned.
•
The medical device may only be set up, operated and used by personnel that have participated in the required
training or that have knowledge of and experience with the product.
•
The operator is obliged to inform his superior/the operator immediately as to any changes on the system that
affect safety and to observe all the safety instructions.
