7
Introduction
Thank you for purchasing the SOMNO HD
TM
from SOMNOmedics. Please read the following
instruction manual carefully before installing and using the device. We gratefully accept any
feedback and helpful suggestions in order to improve our product or our instruction manual.
Please find the safety instructions and important information in the chapter
“Safety
instructions
”, as well as in the individual chapters where they are labelled as follows:
Note:
This is an example.
Intended use
The SOMNO HD
TM
is a mobile device for recording, displaying and saving biophysical
parameters. The device is used as polysomnography system (PSG) for assisting in the
diagnosis of sleep related disorders. The recorded data is displayed graphically on a computer
monitor and can be diagnostically evaluated by trained experts. The device is used in hospitals,
medical offices, neurological sleep centres, clinics or other research facilities where adults’
and
/or infants’ are monitored. The system may also be used in ambulatory settings.
The software DOMINO is part of the system and offers the opportunity to record video signals
or signals of external devices. Those signals are displayed synchronously with the SOMNO
HD
TM
signals.
DOMINO is not providing full diagnosis. The software is supposed to be used by trained
medical experts. DOMINO generates reports of the recorded and manually scored data
(number, index, average values, maximum and minimum, ranges).
This device is not intended to be used as a life support system or together with other
systems in life support applications. The device does not provide an alarm. The device
is not designed to be used as an automatic apnoea monitor.
Patients
The SOMNO HD
TM
and its components may only be used as follows:
- At patients as of the first month of life, no premature infants
Safety instructions
Evaluation and functional diagnosis of the recorded data is intended to be done by trained
medical experts. For evaluation of the data it is necessary to consider all data together. Signal
quality, interfering signals, dropouts and impedance must be checked previously to the final
diagnosis by the user.
Applications with children must be performed under continuous control.
The SOMNO HD
TM
system may not be used in the course of life support monitoring
.
In order to guarantee the correct interpretation of the recorded data the operator should hold
suitable qualifications recognised in their local country.
We recommend that patients with a
cardiac pacemaker
should wear the main device on the
abdomen rather than on the thorax. We recommend placing the main device at least 16 cm
away from the pacemaker. When following these instructions, no signs of interference of the