Potential Complications; Equipment Required; Directions For Use - Bard Magnum Instrucciones De Uso

G. Potential Complications:
Potential complications associated with core biopsy procedures are site specific and include, but are not
limited to:
• hematoma;
• hemorrhage;
• infection;
• adjacent tissue injury;
• pain;
• and air embolism. Air embolism is a rare but serious potential complication of lung biopsy procedures.
Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism.
Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air
embolism.
H. Equipment Required:
• Appropriate imaging modality accessories
• Surgical gloves and drapes
• Local anesthetic
ARD ® UIDE ®
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• RU Coaxial Cannula (optional)
• Scalpel
• Sample collection container
• Other equipment as necessary
I. Directions for Use:
ARD ® AGNUM ®
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Biopsy Instrument preparation:
After following the directions for reprocessing (Reference section J):
1. Using aseptic technique, remove the instrument from its package.
2. We suggest cradling the instrument in your palm with your fingers on the white cocking slide (See Figure 1).
Energize (cock) the instrument by pulling back with full pressure on the white cocking slide twice until both
sleds are fully engaged. Notice the status indicator is now red. (See Figures 2A and 2B.)
3. Test the instrument by first moving the safety lever from "S" (Safe) to "F" (Fire, Ready) then depress the
trigger button to actuate the instrument.
4. Re-energize (cock) the instrument.
WARNING: WHEN THE SAFETY LEVER IS IN THE "F" POSITION, THE INSTRUMENT IS READY TO
FIRE. CARE SHOULD BE TAKEN NOT TO INADVERTENTLY DEPRESS THE TRIGGER AND FIRE THE
DEVICE.
5. Select penetration depth of 22mm or 15mm by moving the lever in the rear of the instrument to the
appropriate setting.
Figure 1
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Biopsy Needle preparation:
The needle has centimeter markings for depth measurement and is packaged with a spacer. The spacer
holds the relative position of the stylet and cannula during insertion either into the patient or into the
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Instrument.
Prior to use, determine the appropriate gauge and length of the needle required for the specific biopsy to be
performed. Using aseptic technique, remove the needle from the package and from the protective sheath.
Precaution: Before using, inspect the needle components for damage. DO NOT USE if the needle
components are damaged. Note: The tip is made with a slight back bend. This is not a defect.
Biopsy Procedure:
The biopsy procedure must be performed using appropriate aseptic technique.
1. Prepare the site as required. Adequate anesthesia should be administered prior to incision of the skin.
Recommendation: For ease of insertion, puncture the skin with a scalpel at the entry site.
• bleeding;
• hemoptysis;
• hemothorax;
• non-target tissue, organ or vessel perforation;
• pneumothorax;
Figure 2A
2
Figure 2B