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The Emprint™ ablation system is intended for use in percutaneous, laparoscopic and intraoperative coagulation (ablation) of soft tissue, such as lung, kidney and liver, including partial or complete ablation of non-resectable liver tumors. Contraindications:
Microwave ablation procedures are not recommended for patients with cardiac pacemaker or other implanted electronic devices.
Potential risks have not been evaluated. Microwave ablation procedures are not recommended for pregnant patients. Potential risks
to the patient and/or fetus have not been established. Risks include but are not limited to tissue irritation or injury, infection and death.
Microwave ablation procedures are not recommended for pregnant patients or those with cardiac pacemakers or other implanted
electronic devices. Thermal injury, electric shock and explosion and fire hazards are possible. Please review the additional warning
and precautions in the User’s Guide prior to use. Risks: While every attempt has been made to reduce patient and user risks, all
surgeries using this device carry some residual risk, even when used by trained physicians. Residual risks include: foreign body in
patient, foreign body reaction, additional needle stick or puncture delay of treatment, post ablation syndrome, pain, fever, malaise,
nausea, vomiting, myalgia, inflammation, hemorrhage, hemoptysis, hematoma, infection, peritonitis, abscess, ascites, seroma,
wound dehiscence, adhesions, ischemia, necrosis, urinary retention, emphysema, pleural effusion, pneumothorax, pulmonary or
upper respiratory fistula, hemothorax, dyspnea, biliary stenosis, biliary obstruction, biloma, cholangitis, biliary cirrhosis, haemobilia,
gastrointestinal fistula, liver dysfunction, hepatic insufficiency, hepatic infarction, jaundice, colonic perforation, renal fistula,
embolism, death, atrial fibrillation, tachycardia, cardiomyopathy, arteriovenous fistula and cancer seeding. Important: Always refer
to the Instructions For Use (IFU) packaged with the product for complete instructions, indications, contraindications, warnings and
precautions.
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