GENICON 2EZEE Instruciones De Uso página 2

BEFORE USING THIS PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
1. This booklet is designed to assist using this product. It is not a reference to surgical techniques.
2. This device was designed, tested and manufactured for single use patient use only.
3. Reuse of this device may lead to its failure and subsequent patient injury.
4. Reprocessing and/or re-sterilization of this device may create risk of contamination and patient infection.
5. Do not reuse, reprocess or re-sterilize this device
DESCRIPTION
The GENICON 2EZee Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb
ring handle, finger rings, tether and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position
by a metallic rim. A tether with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is packaged and
sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
INDICATIONS FOR USE
The GENICON 2EZee Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
CONTRAINDICATIONS
The use of GENICON laparoscopic and endoscopic products is contraindicated whenever endoscopic surgical techniques are contraindicated for any reason.
Contraindications relevant to individual GENICON products are noted in the specific sections.
WARNINGS AND PRECAUTIONS
1. Endoscopic surgery should be performed only by physicians who are thoroughly trained in endoscopic techniques and failure modes, precautions, and
corrective actions in the event of failure.
GENICON single-use products are intended for single patient use only – DO NOT RESTERILIZE, REUSE, or REPROCESS. Resterilization may alter the
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structural and/or functional integrity of this device which may result in patient injury, infection, illness or death. Risk of residual contamination and
resterilization failure may lead to patient injury, infection, illness or death
3. Do not use any pre-sterilized products if the packaging sterile barrier is damaged
4. Consult medical literature or country specific regulations for specific techniques, complications, and hazards prior to procedure.
5. Care must be taken when using laparoscopic instrumentation to avoid damage to major vessels and other anatomic structures.
6. Establish and maintain adequate pneumoperitoneum to reduce the risk of injury to internal structures.
7. Properly position the patient and note anatomical landmarks to introduced devices without unintended damage.
8. Do not use morcellators with this device. Safety and efficacy of the use of morcellators with the GENICON Specimen Retrieval bag have not been
established.
9. Care should be taken to avoid contact of the bag with sharp instruments, cutting devices, and electrosurgical and laser instrument.
10. This device is not intended for use with any tissue that will not fit within the confines of the specimen bag and allow complete closure of the bag.
11. Do not attempt to remove the specimen through the trocar or cannula as this may lead to bag rupture and spillage of contents.
12. The specimen bag includes a radiopaque tab that is clearly visible on CT Scans and may be visible in standard, plain radiography.
13. Excessive forces should be avoided during bag extraction to avoid any bag stretching or tearing. If the bag and its contents are too large to be extracted,
carefully enlarge the access site to facilitate easy bag removal.
14. Devices have been validated for five (5) deployment and extraction cycles on the same patient and must be disposed of after this limit. Exceeding this limit
may cause degradation of the instrument material resulting in premature failure of the device.
15. Verify that the devices are compatible with other products that will be used in surgery prior to the procedure.
16. Transport and store all products safely at ambient temperatures of 5°C to 30°C and relative humidity of 35% to 65 % (non-condensing). Handle with care.
17. Dispose of all used or damaged products using standard hospital practices for biohazard control.
POTENTIAL COMPLICATIONS FOR ALL GENICON
Potential complications associated with the use of laparoscopic devices include but are not limited to organ or vessel damage/perforation, hemorrhage, hematoma,
trocar site hernia, and septicemia/infection.
INSTRUCTIONS FOR USE
1. Inspect all components carefully for damage during shipment, handling or after maintenance. Refer to picture -1-
A. Introducer Shaft
B. Finger Rings/Grip
C. Thumb Ring/Push-Pull Rod
D. Specimen Bag/Opening Support
E. String/Tether with radiopaque tab
F. Closure Suture
2. Inspect sterile packaging, and verify that sterile barriers are intact. Do not use if package is compromised.
3. Verify that the sizes of all surgical components selected are compatible.
4. Open package using sterile technique and place instrument on sterile field.
5. Verify bag is fully inside the Introducer shaft. Refer to picture -1-
6. Insert the instrument through the desired corresponding sized port. Refer to picture -2-
Holding the finger rings, depress the thumb ring. This will advance and deploy the specimen bag/opening support rim into the body cavity. Ensure that "UP"
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on the thumb ring is facing up, indicating that the bag will be in the proper position when deployed. Refer to picture -3-
8. While fully deployed, the open end, or rim, of the bag is maintained in an open position. Unrolling of the bag will be initiated by deployment of the rim element.
The bag maybe unrolled further by using the tip of a blunt laparoscopic instrument, such as the grasper.
9. Place specimen into the specimen bag. Refer to picture -4-
TO REMOVE THE INSTRUMENT, SPECIMEN BAG, AND CANNULA TOGETHER:
A-1. With the bag still attached to the instrument, withdraw the instrument from the cannula until the leading edge of the bag is inside the tip of the cannula.
A-2. Grasp the instrument and cannula and carefully remove from the access site together
NOTE: This method will allow the bag to be redeployed on the same patient. To redeploy the bag once specimen has been removed from bag, do not pull the
closure suture and pull back on the thumb ring until the bag is inside the Introducer shaft then repeat steps 5 through 9 above. Do not repeat this step if
visible wear on bag can be seen or beyond 5 deployment and extraction cycles.
NOTE: If the bag and its contents are too large to be extracted, carefully enlarge the access site to facilitate easy bag removal.
TO REMOVE THE SPECIMEN BAG AND CANNULA TOGETHER:
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