EDAN SONOTRAX Basic User Manual - Chapter 1 Safety Guide
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide
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Chapter 1 Safety Guide
NOTE:
This user manual is written to cover the maximum configuration. Therefore, your model
may or may not have some of the parameters and functions described, depending on
what you have ordered.
1.1 Intended Use
The SONOTRAX Series Ultrasonic Pocket Dopplers are intended to be used by health care
professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and
physicians assistants, by prescription from licensed physicians in hospitals, clinics and private
offices.
The 2 MHz and/or 3 MHz waterproof probes are indicated for the detection of fetal heart rate
from early gestation thru delivery and as a general indication of fetal well being. They can also be
used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of
blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
1.2 Safety Precautions
This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type B applied
part. Type B protection means that the connection between the equipment and personnel
complies with permitted leakage currents and dielectric strength of IEC/EN 60601-1.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
WARNING
1 This device is not intended for treatment.
2 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
3 Do not touch the signal input/output connector and the patient simultaneously.
4 We recommend that exposure to ultrasound should be kept as low as reasonably
achievable. This is considered to be good practice and should be observed at all
time.
5 Only use probes provided by the manufacturer.
6 The stretching length of probe cable should be less than two meters in order to avoid
the cable breaking away from the probe socket.