BD EnCor Manual Del Usuario

Needle Guide (Fischer
ENGLISH
ENCFNGUIDE01
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
Information in the Instructions for Use should be discussed with the patient, at the
discretion of the physician
Device Description
Breast Biopsy Probe when mounted to the Fischer™/Mammotest™
and lockable clamp adaptable to the Fischer™/Mammotest™ rail. A sterile,
disposable EnCor™ Needle Guide Insert (ENCFINSERT12G, ENCFINSERT10G,
Indications for Use
The EnCor™ Needle Guide is intended to support the EnCor™ Breast Biopsy
Probe in a Fischer™/Mammotest™ prone biopsy table.
Contraindications
This device is not intended for use except as indicated.
Warnings
• Do not use in the presence of infection.
• The EnCor™ Needle Guide Insert has been designed for single use
only. Reusing this medical device bears the risk of cross-patient
contamination as medical devices – particularly those with long and
pyrogenic or microbial contamination have had contact with the medical
device for an indeterminable period of time. The residue of biological
material can promote the contamination of the device with pyrogens or
microorganisms which may lead to infectious complications.
• Do not resterilize the EnCor™ Needle Guide Insert. After resterilization,
the sterility of the product is not guaranteed because of an
indeterminable degree of potential pyrogenic or microbial contamination
which may lead to infectious complications. Cleaning, reprocessing and/
or resterilization of the present medical device increases the probability
• After use, the EnCor™ Needle Guide Insert may be a potential biohazard.
Handle and dispose of in accordance with acceptable medical practice
and applicable local, state, and federal laws and regulations.
Precautions
• This device should only be used by physicians trained in percutaneous biopsy
procedures.
• Carefully inspect the device prior to use to verify that device has not been
• Sterilization of the EnCor™ Needle Guide is not necessary under normal use
conditions.
Potential Complications
Potential complications may include, but are not limited to hematoma,
Note: Users and/or patients within the European Union, should report any serious
incident that has occurred in relation to the device to the manufacturer and the
competent authority of the Member State in which the user and/or patient is
Users outside of the European Union should report any serious incident that has
of the country in which the user and/or patient is established.
How Supplied/Stored
use only.
Equipment Required
•
• Appropriate biopsy probe and system
• Fischer™/Mammotest™ Stereotactic Biopsy Table
• EnCor™ Needle Guide
• EnCor™ Needle Guide Insert
•
™ ) • Local anesthetic
• Scalpel
•
Directions For Use
1 stereotactic
EnCor™ Needle
Guide (A)
1. Remove the EnCor™
2. Install the EnCor™ Needle Guide (A) onto the Table Rail (B) from the front.
Needle Guide (A) rearward onto the Table Rail (B). Release the Rail Clamp
Lever (C).
Note:
the EnCor™ Needle Guide (A) on the Table Rail (B).
3. Install the EnCor™
Cleaning and Maintenance
Note: The EnCor™ Needle Guide is not intended to be sterilized.
Instructions for the EnCor™ Fire Forward Accessory, refer to the EnCor™ Fire
Forward Accessory Instructions for Use.
Manual Cleaning
After each use, immediately clean the EnCor™ Needle Guide with the steps
outlined below.
1. Remove the EnCor™ Needle Guide Insert (E) from the EnCor™ Needle Guide
Insert (E) in accordance with acceptable medical practice and applicable local,
3. For the steps mentioned above, ensure all surfaces of the EnCor™ Needle
Guide (A) are wiped continuously and remain wet with a contact time of
3 minutes minimum.
present.
the next section.
Disinfection
1. Re-wipe
Pay close attention to all cracks and crevices on the EnCor™ Needle
Guide (A) during wipe-down.
2. Ensure all surfaces of the EnCor™ Needle Guide (A) are wiped continuously,
and remain wet, with a contact time of 3 minutes minimum.
1
EnCor™ Needle Guide
Insert (E)
Needle Guide
Insert Hole (F)
Figure 1. EnCor™ Needle Guide (Fischer™/Mammotest™ Table)
Attaching the EnCor™ Needle Guide to the Table:
Table Rail (B)
Slider (D)
Rail Clamp Lever (C)