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It is very important to protect the SOMNOwatch™ plus from temperatures below
0°C and above 50°C
. Furthermore the SOMNOwatch™ plus should not be worn
during swimming and showering.
Please refer to the safety instructions in chapter 3.
1 Introduction
The SOMNOmedics team would like to thank you for purchasing this product. We are confident that
you will enjoy using the
SOMNOwatch™ plus for many years. The SOMNOwatch™ plus has been
developed by SOMNOmedics to meet the highest quality control standards available.
Indication for Use:
The SO
MNOwatch™ plus is a non-life-supporting portable physiological signal recording device
intended to be used for long-term blood pressure recordings on adult patients.
The
SOMNOwatch™ plus is not intended to be used alone or in combination with another product as
a life support device, a life support system, or as a critical component to a life support device or
system. There is no claim of compatibility with diagnostic imaging equipment.
Caution: Federal law restricts this device to sale by or on the order of a physician.
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.
In order to obtain the best results from your system, we recommend that you carefully read this
instruction manual before connecting the
SOMNOwatch™ plus to a patient.
Technical Specifications are subject to change without notice.
The SOMNOwatch™ plus is available in three configurations allowing it to be used for Basic
Respiratory Screening, Sleep Recording and Long-term blood pressure Recording.
The Initialisation of the System and Analysis of the Data must be performed by Trained Operators.
Measurements can be performed in the surgery 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.
It may also be useful to give the patient a copy of the enclosed Patient Instruction Manual. The
initialised device will
automatically
start recording the measurement at the preset time. The data
transfer and the analysis must be performed by the doctor.
1.1 About this instruction manual
It is essential that you read each paragraph carefully when you see this icon on the left
of that paragraph. This icon indicates potential danger to Patients, Property, Data Loss
or in connection with external devices. This icon also appears on the label on the
bottom of the
SOMNOwatch™ plus. This instruction manual is a part of the device and
it must be available at all times.
