Armstrong Medical AquaVENT FD140, Instructions For Use Manual

Page: 12 / 96

2 Safety
10 Instructions for Use, AquaVENT
®
FD140, Rev. 12
2.1 Safety precautions
Reference:
These instructions for use describe the product:
AquaVENT
®
FD140
CPAP respiratory therapy device
Software version 1.13.0
Hardware version 1.02
Safe operation:
In order to guarantee the safe operation of the AquaVENT
®
FD140, the
device must only be used as described. Before putting the AquaVENT
®
FD140 into operation, users must familiarise themselves with these
instructions for use. Only instructed staff are allowed to use the AquaVENT
®
FD140. As a matter of principle, all directions in these instructions for use
and all legal provisions must be observed for the use of this respiratory
therapy device.
Classification:
The AquaVENT
®
FD140 is a Class IIb device according to Directive
93/42/EEC concerning medical devices, Annex IX, section 1.3, rule 3,
section 3.1, rule 9 and section 3.2, rule 11.
Classification according to EN 60601-1 Medical electrical equipment -
General requirements for basic safety and essential performance:
DEVICE OF PROTECTION CLASS I, with earth conductor for protection
against electric hazards.
CONTINUOUS OPERATION if applied in compliance with the INTENDED
USE and within the indicated temperature limits.
Service and maintenance:
To ensure its safety and proper functioning, the AquaVENT
®
FD140 should
be checked once every year. Repairs, service and maintenance on the
device must only be carried out by authorised service technicians. For
maintenance intervals and measures to take, please refer to chapter 8
Maintenance.