Exsurco Medical Amalgatome SD, User Manual

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A
MALGATOME
®
SD U
SER
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PN#: X101456, Rev. C Page 9 of 56
General Warnings and Precautions
This section provides general warnings and precautions about the Amalgatome SD System.
Warnings
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The user of the Amalgatome SD System must be a surgically trained professional (e.g., a surgeon) and
thoroughly familiar with the function, application, and instructions for use in order to avoid injury to the
patient and operating staff.
•
Each physician must evaluate the appropriateness of the technique for each patient based on his or her own
medical training and expertise. Care should be taken in treating individuals with pre-existing conditions that
might affect the success of the surgical procedure. Every patient is different and results can vary.
•
This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound.
•
Only use the Amalgatome SD sterile, disposable, excision ring excision ring blades with the Amalgatome SD
System.
•
Do not use excision ring blades from other manufacturers.
•
Do not reuse the excision ring blades as they are intended for single use. Serious injury can result from use of
other manufacturer’s excision ring blades or reuse of the Amalgatome SD excision ring blades. Dispose of the
excision ring blades in accordance with facility protocol for sharps containment.
•
Sharpening of the excision ring blade or removal of excision ring blade material will result in loss of
calibration.
•
Care should be taken when removing the excision ring from its packaging. The excision rings are extremely
sharp.
Precautions
•
The Amalgatome SD System operator and other clinical personnel should follow the universal protocol for
aseptic technique as with all surgical procedures.
•
As with all surgical procedures, the surgical team and clinical personnel should follow the universal
precautions for infection control. (including the use of surgical gloves, facemask that covers the mouth and
nose, protective eye wear or shield, protective clothing and anti-slip shoe covers.) Especially during
debridement procedures due to possible tissue spray
•
It is recommended prior to clinical use of the Amalgatome SD System, that all operators of the system be
trained in its proper use. Contact your local Exsurco Medical Sales Representative for all details regarding
Amalgatome SD training.
•
United States of America (USA) federal law restricts this device to sale by or on the order of a physician.