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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 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 GENICON Pnuemo-Needle is a sterile, disposable Veress needle which is available in 120mm and 150mm length. The device is equipped with a spring-
loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male
luer lock connector for secure CO
INDICATIONS FOR USE
The GENICON Pnuemo-Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish
pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
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 disposable products are intended for single patient use only – DO NOT RESTERILIZE.
2.
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 excessive force or in a manner not consistent with normal instrumentation use.
9.
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.
10. Carry out electrosurgical procedures using only non-combustible gases (CO
11. Verify that the devices are compatible with other products that will be used in surgery prior to the procedure.
12. Store all products safely in a climate controlled environment and handle with care.
13. All GENICON devices are latex free and sterilized using gamma sterilization, except as noted.
14. 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 sterile packaging, and verify that sterile barriers are intact. Do not use if package is compromised.
2.
Remove needle protector. Refer to picture -1-
3.
Inspect all components carefully for damage during shipment, handling or after maintenance. Refer to picture -2-
A.
CO
Luer Port/Valve
2
B.
Indicator
C.
Grip
D.
Outer Needle
E.
Inner Blunt Tip
4.
The insufflation (CO
) valve is packaged in the CLOSED position (red slide valve fully depressed). To insufflate the abdomen, attach the CO
2
luer connection, and press the green colored slide valve fully. Refer to picture -3- To stop insufflation and close the valve, press the red colored slide valve
fully. Refer to picture -4-
5.
Using laparoscopic technique, select entry site advance the needle through the skin and fascia.
6.
Attach a syringe to the Luer fitting. Refer to picture -5-
7.
Open the airflow switch, and draw back the syringe plunger to aspirate through the needle. Refer to picture -6- Presence of blood or other liquid indicates
potential perforation of organs or vessels.
8.
If there is NO aspiration, the insufflation line may be connected to obtain pneumoperitoneum. Refer to picture -7-
Once sufficient insufflation is obtained, position the airflow switch to the "OFF" position and remove the needle when desired.
9.
LESEN SIE DIE FOLGENDEN INFORMATIONEN GRÜNDLICH, BEVOR SIE DIESES PRODUKT VERWENDEN.
WICHTIG!
1.
Diese Broschüre dient dazu, Sie bei der Anwendung dieses Produkts zu unterstützen. Es ist kein Nachschlagewerk für chirurgische Verfahren.
2.
Dieses Gerät wurde für die einmalige Nutzung am Patienten entworfen, getestet und produziert.
3.
Die Wiederverwendung dieses Geräts führt zu Fehlfunktionen und daraus resultierender Verletzung des Patienten.
4.
Wiederaufbereitung bzw. Resterilisation dieses Geräts kann zu einer Kontaminierung und Infektion beim Patienten führen.
5.
Dieses Gerät nicht wiederverwenden, aufbereiten und resterilisieren
BESCHREIBUNG
Die GENICON Pnuema-Nadel ist eine sterile, Einweg Veress-Nadel, die in den Längen 120 mm und 150 mm verfügbar ist. Das Gerät verfügt über einen
federbetriebenen Obturator mit abgerundeter Spitze. Darüber hinaus gibt es einen „Schiebeschalter", der eine einfache EIN-AUS-Steuerung des Gasflusses
ermöglicht. Das proximalste Ende verfügt über einen Luer-Lock-Steckverbinder zum sicheren Anschluss an die CO
©
© GENICON
gas line connection.
2
®
PRODUCTS
EN – ENGLISH
).
2
DE – GERMAN
Veress_AB
2
-Gasleitung.
2
supply to the
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