User's Manual

SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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Chapter 1 Safety Guide
NOTE:
Familiarize yourself with this user manual before attempting to operate the Doppler.
Follow the operation and maintenance instructions to ensure proper use of it.
1.1 Intended Use/Indications for Use
The SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop
Doppler (hereinafter called “SD6”) are intended to be used by health care professionals including
registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by
prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz obstetrical 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.
1.2 Safety Precautions
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 SD5/SD6 Ultrasonic TableTop Doppler is a tool to aid healthcare professionals and
should not be used in place of normal fetal monitoring. It is not intended for
treatment.
2 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
3 SHOCK HAZARD – In order to protect the patient and the operator, the device case
should be grounded. The power receptacle must be a three-slot grounded outlet.
4 SHOCK HAZARD – Do not attempt to connect or disconnect a power cord with wet
hands. Make sure that your hands are clean and dry before touching a power cord.
5 Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the system standard IEC/EN
60601-1. Anybody who connects additional equipment to the signal input connector
or signal output connector to configure a medical system must ensure that the
system complies with the requirements of the valid version of the system standard
IEC/EN 60601-1. If in doubt, consult our technical service department or your local
distributor.
6 Exposure to ultrasound should be kept as low as reasonably achievable.