Idiomas disponibles
Idiomas disponibles
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 resterilization of this device may create risk of contamination and patient infection.
5.
DO NOT reuse, reprocess or resterilize this device.
DESCRIPTION
The Single-Use GENICON Suction Irrigation device consists of a hand-piece equipped with two trumpet style valves, a probe with vents to produce suction and
irrigation, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The
valves allow controlled irrigation and aspiration during a surgical procedure.
The Single Use GENICON Suction Irrigation device can accommodate the gravity fed system, and powered pump system.
PROBES/ELECTROCAUTERY COMPATIBILITIES
The Single-Use GENICON Suction Irrigation System is compatible with GENICON electro cautery and Stryker probes.
INDICATIONS FOR USE
The GENICON Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has
applications in laparoscopic, gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris
from the operative site during laparoscopy to aid visualization.
CONTRAINDICATIONS
1.
The Single Use GENICON Suction Irrigation device is NOT intended for contraceptive coagulation of fallopian tissue.
2.
This device is not intended for used except as indicated.
3.
Use of this device for hysteroscopy or for cavity distention is contraindicated.
WARNINGS AND PRECAUTIONS
1.
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.
2.
This device is NOT intended to generate high pressure irrigant streams in hysteroscopic procedures or encapsulated areas.
3.
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.
4.
When not using suction, ensure that the trumpet valve providing suction does not remain pressed so as to minimize loss pneumoperitoneum.
5.
Never pass irrigation fluid through the probe during coagulation.
6.
When using the mono-polar probes, verify that the tip is not in contact with a conductive irrigation fluid.
7.
Sufficient care and distance must be maintained during use to prevent arcing to other instruments.
8.
This device is provided STERILE and is intended for SINGLE procedure ONLY. DISCARD AFTER USE. DO NOT RESTERILZE.
9.
Do not use any pre-sterilized products if the packaging sterile barrier is damaged
10. Consult medical literature or country specific regulations for specific techniques, complications, and hazards prior to procedure.
11. Care must be taken when using laparoscopic instrumentation to avoid damage to major vessels and other anatomic structures.
12. Establish and maintain adequate pneumoperitoneum to reduce the risk of injury to internal structures.
13. Properly position the patient and note anatomical landmarks to introduce devices without unintended damage.
14. Do not use excessive force or in a manner not consistent with normal instrumentation use.
15. A thorough understanding of the principles and techniques involved in laparoscopic electrosurgical procedures is essential to avoid shock and burn hazards
to both patient and medical personnel, and damage to the device or other surgical instruments.
16. Carry out electrosurgical procedures using only non-combustible gases (CO2).
17. Verify that the devices are compatible with other products that will be used in surgery prior to the procedure.
18. Store all products safely in a climate controlled environment and handle with care.
19. GENICON Suction Irrigation devices are DEHP / Latex free and sterilized using gamma sterilization, except as noted.
20. 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
Inspect all components carefully for any damage that may have occurred during shipment, or where applicable, routine maintenance. Inspect packaging marked as
sterile, and verify that sterile barriers are intact. Do not use if sterile package is damaged or opened.
Follow the steps below for use of the Single Use GENICON Suction Irrigation System.
1.
Open the package by using standard sterile technique.
1.1. Some GENICON Suction Irrigation products are packaged in two pouches. Both the inner and outer pouch are sterilized prior to sale. Open both
pouches using standard sterile technique.
2.
Check the probe(s) for damage. Dispose of probe if damaged. Refer to picture -1-
A. Tip Protector
B. Probe
C. Trumpet Valve
D. Tubing
E. Suction Connector
F. Pressure Chamber (powered product only)
G. Clamp(s)
H. Bag Spike(s) with Protector(s)
3.
To remove the probe, twist the probe nut in a counter clockwise motion. To attach/tighten the probe, twist in a clockwise motion. If probe is equipped with a
mono-polar post, tighten until post points upward. Refer to picture -2-
4.
If applicable, remove the colored tip protector that is found on the end of the probe. Refer to picture -3-
5.
To hook up the irrigation tubing to the irrigation bag: remove the tip protector from the bag spike(s) (Refer to picture -4-, step -1-) close the tubing clamp(s)
(Refer to picture -4-, step -2-) located near the bag spike(s) and insert the bag spike(s) to the irrigation fluid bag (Refer to picture -4-, step -3-). If the
second irrigation bag is not in use, clamp the irrigation tube which is not in use with the attached tubing clamp to eliminate the loss of irrigation fluid.
For GENICON powered Suction/Irrigation – insert Pressure Chamber (F) into GENICON 717-000-000 Irrigation Pump. Refer to Irrigation Pump instruction for
6.
use Section 4-3.
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PRODUCTS
IFU – Lavage – 9999-997 Rev J
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