US endoscopy Histoguide Gebrauchsanweisung Seite 2

Not made with natural rubber latex.
Intended Use: The disposable wire-guided forceps is intended to sample tissue from lesions that can occur within the
gastrointestinal tract.
Description
Histoguide™ wire-guided forceps
Design Features:
•
Easy to use spring loaded handle is designed to keep the jaws closed until ready for use and prevent specimen loss during
exchanges. SEE FIG.1.
•
Wire guide for easy and safe guide wire exchange. SEE FIG.2.
•
Metallic biopsy cups for enhanced fluoroscopic imaging.
Warnings and Precautions:
•
Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic procedure
and ERCP.
•
The sampling of tissue within and outside the gastrointestinal tract should only be performed by persons having adequate training
and familiarity with endoscopic techniques procedures and ERCP.
•
Care should be exercised when grasping the targeted tissue to avoid inadvertently grasping tissue or organs not intended for retrieval.
•
For best results keep the guide wire wet.
•
If any resistance is felt during device manipulation STOP and determine the cause prior to proceeding.
•
Fluoroscopic guidance is recommended when using this device.
•
Sphincterotomy is recommended when using this device.
•
Optimal technique for tissue sampling will vary depending upon the type or clinical conditions found during endoscopy and ERCP.
•
Use caution to minimize risk of any SHARPS injury.
•
Do not use in the pancreas due to pancreatitis risk.
•
Wear appropriate Personal Protective Equipment.
•
Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. US Endoscopy did not design this device
nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this
disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
Complications:
•
Those associated with gastrointestinal endoscopy include but are not limited to:
•
Pancreatitis
•
Perforation.
•
Bleeding or hemorrhage.
•
Aspiration, fever, infection, allergic reaction to medication.
•
Hypotension, respiratory depression or arrest cardiac arrhythmia or arrest.
Contraindications:
•
Those specific to any endoscopic procedure.
•
Those specific to ERCP procedure or procedure where gaining access to a specific site is desired.
•
Patients with known or suspected coagulopathy.
•
Use in the pancreas
Prior to use:
1. Confirm that the biopsy forceps are compatible with the inner channel of the endoscope (min 4.2mm channel).
2. Read the entire Instructions for Use and familiarize yourself with the device.
3. Visually inspect the packaging for damage.
4. Open the package, remove and uncoil the entire device slowly.
5. Visually inspect the device for damage.
6. Drape the sheath in a "U" shaped configuration
7. Actuate the device by moving the Slider back and forth to confirm that the jaws open and close smoothly. SEE FIG.1. If the unit
does not function properly, or there is evidence of damage to the device or package (e.g. bends, kinks, or misaligned jaws,
damaged packaging) do not use this product and contact your local Product Specialist.
Directions for Use:
NOTE: Once access to the sampling site is achieved and a guidewire is placed through the stricture, proceed with the following steps;
1. Identify the lesion to be sampled via fluoroscopic imaging, and maintain visualization throughout the use of the forceps.
2. Insert the guidewire into the WIRE GUIDE attached to the biopsy cups. SEE FIG.2.
3. Slide the forceps over the guidewire.
00732513 Rev. C
Product Sheath
Number Diameter Diameter
00711660 2.1mm 2.2 mm
.
Jaw
Jaw Device
Opening
Length
Width
8 mm 2300 mm
Combined Wire
Recommended
Guide & Sheath
Guidewire Diameter
Diameter
(See Fig. 2)
0.140in / 3.5mm 0.035in / 0.89mm