Instructions for use | Oxylog VE300 SW 1.n 9
Safety-related information
2.5 Essential performance characteristics
Provided that the essential performance characteristics are functioning correctly,
the product can be used for its intended purpose. The product has the following
essential performance characteristics:
Provision of controlled and monitored patient ventilation with user-defined pressure
limitation for airway pressure or the triggering of a corresponding alarm.
If CO
2 measurement (option) is active, the product has the following additional
essential performance characteristics:
– Adherence to the specified CO
2 measurement accuracy
– Triggering of an alarm if the alarm limit set by the user is exceeded
– Triggering of an alarm if the specified CO
2 measurement accuracy cannot be
maintained
In the event of an external power supply failure, the device automatically switches
to the internal battery.
2.6 Target groups
2.6.1 Intended users
The device is intended for use by and under the supervision of trained healthcare
professionals, e.g., doctors, nurses, emergency medical technicians, respiratory
therapists, and paramedics.
2.6.2 Definition of target groups
The target groups may only carry out the following activities if they meet the
necessary requirements.
2.6.2.1 Users
2.6.2.2 Reprocessing personnel
2.6.2.3 Service personnel
Task Requirement
Use of the product in accordance with
the intended use
Specialist medical knowledge in respira-
tory care and the use of the medical
device
Task Requirement
Reprocessing Specialist knowledge in the reprocess-
ing of medical devices
Task Requirement
Installation Specialist knowledge in electrical engi-
neering and mechanics
Experience in the servicing of medical
devices
Basic service work (inspection, mainte-
nance according to the "Service" chap-
ter)