SOMNOmedics SOMNOtouch RESP eco, Instruction Manual

Page: 5 / 54

- 5 -
1 Introduction
The SOMNOmedics team would like to thank you for purchasing this product. We are confident that
you
will enjoy using the SOMNOtouch™ RESP eco for many years. The SOMNOtouch™ has been
developed by SOMNOmedics to meet the highest quality control standards available.
Caution: Federal law restricts this device to sale by or on the order of a physician.
In order to obtain the best results from your system, we recommend that you carefully read this
instruction
manual before connecting the SOMNOtouch™ RESP eco to a patient.
Advice and suggestions to improve the functionality of the device and this manual we will be gratefully
accepted.
Warning: Take care in arranging patient and sensor cables to avoid risk of patient entanglement or
strangulation. To minimize the risk of patient strangulation, the sensor and electrode cables
must be carefully placed and secured.
Technical Specifications are subject to change without notice.
The Initialisation of the System and Analysis of the Data must be performed by Trained Operators.
Measurements can be performed in professional healthcare facilit
ies or at the Patients’ home. When
used at the Patients’ home, the Patient should be carefully instructed on how to use and care for the
system.
Please also hand out to the patient a copy of the enclosed Patient Instruction Manual. The initialized
device will
automatically start recording the measurement at the pre-set time. The data transfer and
the analysis must be performed by the doctor or qualified physiologist.
The
SOMNOtouch™ RESP eco may not be worn during swimming and showering.
Please refer to the safety instructions in chapter 0.
1.1 Intended Use
The SOMNOtouch
TM
RESP eco is a portable physiological signal recorder. It is indicated for use in the
recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of
assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients.
The device is intended to be prescribed for use by a physician in the office, sleep laboratory or
pa
tient’s home.
This device is NOT designed to be used in life support situations.
1.2 Patients
The SOMNOtouch
™ RESP eco and its components may only be used as follows:
- For adults only
- Excluded are monitored and intensive care patients