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Digital Color Doppler Palm Ultrasound System
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performance. You need to perform a more thorough inspection, including the cable, strain relief, and
connector, each time you clean the system.
Electrical leakage checks should be performed on a routine basis by CHISON Service or qualified hospital
personnel.
Mechanical hazard:
A defective system or excess force can cause patient injury or system damage:
Inspect systems for sharp edges or rough surfaces that may injure sensitive tissue.
DO NOT apply excessive force to the system connector when inserting into the system port.
Special handling instructions
Using protective sheaths
The use of market cleared system sheaths is recommended for clinical applications. Reference FDA March
29, 1991 "Medical Alert on Latex Products".
Protective sheaths may be required to minimize disease transmission. System sheaths are available for use
with all clinical situations where infection is a concern.
DO NOT use pre-lubricated condoms as a sheath. In some cases, they can damage the system. Lubricants
in these condoms may not be compatible with system construction.
Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA’s
March 29, 1991 Medical Alert on latex products.
DO NOT use an expired system sheath. Before using a sheath, verify if it has expired.
System handling and infection control:
This information is intended to increase user awareness of the risks of disease transmission associated with
using this equipment and provide guidance in making decisions directly affecting the safety of the patient as
well as the equipment user.
Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct
physical contact.
Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in
a routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly
with the type of contact.
One of the most effective ways to prevent transmission between patients is with single use or disposable
devices. However, ultrasound transducers are complex and expensive devices that must be reused
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