COOK Medical BIGopsy, Instructions For Use Manual, Page: 5 / 48

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ENGLISH
INTENDED USE
The BIGopsy® Backloading Biopsy Forceps is intended for obtaining tissue samples for
pathological evaluation. The device may also be used for retrieval of specimens from the
urinary tract. This device is intended for use by physicians trained and experienced in
ureteroscopic procedures. This device should be used with a ureteral access sheath. Intended
for one time use.
NOTES
If the package is opened or damaged when received, do not use. Visually inspect the product
to ensure no damage has occurred. If an abnormality is detected that would prohibit proper
working condition, do not use. Please notify Cook for return authorization. Do not use this
device for any purpose other than the stated intended use.
Inventory rotation of sterile products is essential. Verify the expiration date of the package
label prior to using the product. If the expiration date has lapsed, do not use or resterilize
the device. Cook Medical devices must be stored in a dry location, away from temperature
extremes.
CONTRAINDICATIONS
Contraindications include those specific to the primary ureteroscopic procedure performed in
gaining access to the desired biopsy or retrieval site.
WARNING
Do not force the device during the procedure; proceed with caution if excessive
resistance is encountered.
CAUTIONS
This device is conductive. Avoid contact with any electrified instrument.
U.S. Federal Law restricts this device to sale by or on the order of a physician.
SUGGESTED INSTRUCTIONS FOR USE Illustrations
1. Prior to attaching the handle, back load the BIGopsy® forceps into the working channel
of the endoscope. Note: The BIGopsy® Backloading Biopsy Forceps component parts are
indicated in Fig. 1.
2. Secure the handle to the forceps according to instructions as follows:
a) With the button depressed, retract the finger spool over the button.
b) Secure handle in this position by releasing the button (Fig. 2). The forceps shaft may
now be introduced into the handle.
c) Feed the forceps shaft through the handle (Fig. 3a). When the forceps shaft is visible in
the viewing window of the handle (Fig. 3b) press button to release finger spool (Fig. 3c).
This secures the forceps shaft in the handle.
3. After the handle is attached, ensure the operation of the biopsy cups before surgical
introduction. Biopsy cups default to the closed position. To open the biopsy cups pull
the finger spool towards the thumb ring (Fig. 4a). To close, push the finger spool forward
(Fig. 4b). Note: Biopsy cups need to be in the closed position before surgical introduction.
4. Through a previously placed ureteral access sheath, advance endoscope with the forceps
to the desired biopsy or retrieval site and proceed with biopsy or specimen retrieval.