Steris Moray 00711889 Mode D'emploi page 2

This device is not made with natural rubber latex.
Intended Use: The disposable Moray
gastrointestinal tract (e.g. pancreas).
Description
®
Moray micro forceps
Warnings and Precautions:
•
Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic
procedure.
•
The sampling of tissue within and outside the gastrointestinal tract should only be performed by persons having adequate training
and familiarity with endoscopic and endoscopic ultrasound techniques.
•
Always use appropriate PPE when performing endoscopic and endoscopic ultrasound tissue sampling procedures.
•
If using the device through an FNA needle, make sure to maintain EUS visualization of forceps at all times during usage. Losing
visualization of forceps may allow the end user to advance forceps too far, potentially injuring surrounding tissue or structures.
•
Care should be exercised when grasping the targeted object to avoid inadvertently grasping tissue or organs not intended for retrieval.
•
Optimal technique for tissue sampling will vary depending upon the type or clinical conditions faced during endoscopy.
•
The risks associated with using this device through an FNA needle under EUS guidance are similar to the risks incurred when
standard EUS FNA is performed.
•
Use caution when handling included extraction pick to minimize risk of sharps injury.
•
Never swish forceps in preservative medium (i.e., formalin, methanol, alcohol fixatives, etc.) to facilitate removal of specimen from
jaws if an additional pass with the forceps is warranted. Doing so may expose patient to potentially toxic material.
•
Use included extraction pick or swish in saline to facilitate specimen removal.
•
If the jaws of the Moray
they reopen.
•
If functionality returns to jaws, remove any excess tissue and place in specimen container.
•
If continued use is warranted continue to use the device.
•
If functionality does not return to device, do not use this product and contact your local Product Specialist for return.
•
Open up additional device if further specimen acquisition is warranted.
•
This device has not been designed nor is it intended to be used with electrosurgical devices. If use of an electrosurgical device is
desired, completely remove the Moray
•
Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. STERIS 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).
Contraindications:
•
Those specific to any endoscopic procedure.
•
Those specific to any endoscopic ultrasound FNA procedure or procedure where gaining access to a specific site is desired.
•
Patients with known or suspected coagulopathy.
Prior to use:
1. Confirm that the Moray
needle, catheter, endoscope)
2. Read the entire Instructions for Use and familiarize yourself with the device.
3. Place device package on flat surface with label facing up.
®
4. Remove Tyvek cover by grasping corner and slowly peeling it away from plastic tray. (See Figure 1)
5. Remove device retention tube from tray. (See Figure 1)
6. Unseat handle from tray at cutout point 1 using thumb and index finger of one hand to grasp handle. (See Figure 1)
7. Maintain grasp of handle.
8. Remove the rest of device by using thumb and index finger of other hand to grasp coiled sheath from cutout point 2. (See Figure 1)
9. Slowly move hand to a position on the coiled sheath that is a few inches from the distal end of device. (See Figure 2)
10. Uncoil the entire device slowly.
11. Visually inspect the device for damage.
12. Drape the sheath in a "U" shaped configuration
13. Actuate the device by moving the Slider back and forth to confirm that the jaws open and close smoothly. (See Figure 2). If the
unit does not function properly, or there is evidence of damage (e.g. bends, kinks, or misaligned jaws) do not use this product
and contact your local Product Specialist.
00732071 Rev. F
®
micro forceps is intended to sample tissue from lesions that can occur within and outside the
Product
Number
00711889
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micro forceps become stuck in a closed position, rinse jaws in sterile saline while actuating handle until
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micro forceps from the endoscope prior to actuating the electrosurgical device.
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micro forceps is compatible with the inner channel of the endoscopic delivery device. (19G FNA
.
Sheath Jaw Diameter
Diameter
0.80 mm 0.76 mm
Jaw opening Device Length
Width
4.3 mm 2300 mm
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