X-Stream™ Irrigation System

Indications

The X-Stream™ Irrigation System is designed to provide controlled irrigation to the operative site during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid visualization. It may also be useful for resection of filmy adhesions (hydrodissection), hydrodissolution of blood clots and peritoneal lavage.

When fitted with an electrosurgical attachment or insert, the device may be used for cutting, dissection and coagulation of tissue using monopolar or bipolar energy – depending on the electrosurgical accessory utilized. When fitted with the proper adapter and probe tip, the device may be used to introduce a laser fiber or laparoscopic surgical instrument into the peritoneal cavity during a laparoscopic procedure.

Contraindications

1. Use of this device for hysteroscopy or for cavity distention is contraindicated.
2. Use of this device for intra-abdominal irrigation is contraindicated whenever laparoscopy is contraindicated. See operator’s manual of your laparoscope for absolute and relative contraindications.
3. Use of monopolar electrosurgical instruments and inserts with an uninsulated metallic probe tip is contraindicated.

Warnings

1. This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user.
2. As with any surgical procedure where extensive irrigation is utilized, intravasation levels should be closely monitored by the attending physician.
3. The pressure accuracy of the X-Stream™ System depends on proper setup. It is important that the bottom of X-Stream™ Controller be positioned at least 12 inches above the highest height of the patient to provide sufficient pressure for optimal performance of the system.
4. The X-Stream™ Irrigation System is capable of generating high irrigation impact forces and flow rates. Use the minimum pressure necessary at all times to accomplish the procedure.
5. The X-Stream™ Irrigation System will generate even higher irrigation impact forces (compared to impact forces generated via a 5mm standard probe tip) when used with the Davol 10mm Endo-Pool, 10mm Hydro-Dissection Channel Probe or the 5mm Micro Probe tips.
6. Electrosurgery instruments or electrode inserts must not be used with uninsulated metallic probe tips. Electrosurgery instruments and inserts should be used only with available Davol non-conductive or insulated probe tips.
7. When using electrosurgical attachments or inserts, follow all instructions, warnings, precautions, and contraindications provided with these devices.
8. The tubing set will provide gravity flow if the pumping chamber is not properly loaded into the controller’s pumping chamber receptacle.
9. Do not modify this equipment without authorization of Davol, as it may compromise the safety and effectiveness of the device.
10. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe and effective use of the equipment.
11. Davol m ust be contacted for instructions regarding the correct replacement of interchangeable or detachable parts.

Precautions

1. The controller automatically turns “ON” when the tubing set is loaded into the controller. The logo and PRIME LED’s will light to indicate that the controller is on. There is no “ON/OFF” switch.
2. If package is damaged or open, do not use product.
3. Do not remove the square, metal contact label located at the top back of the pumping chamber.
4. The bottom of the controller assembly should be at least 12 inches above the highest height of the patient at any time during surgery.
5. Use of irrigation bottles is NOT recommended because performance is diminished by air being pulled into the controller before it can be vented into the bottle. However, if ir r igation bottles are used, simultaneously using two (2) bottles with a “Y” connector (optional Dual Spike Adapter REF 0026110) will alleviate the air entry issue. For optimum performance, use of irrigation bags is recommended.
6. After use, the tubing set, trumpet valve and probe tip are a potential biohazard. Handle and dispose of as required by hospital policy and applicable laws.
7. Please refer to the X-Stream™ Controller Operator’s Manual for additional information.
8. Adhesions, anatomical anomalies or other conditions may prevent clear visualization of internal anatomy. Do not perform laparoscopic procedures if the internal anatomy cannot be positively identified.
9. Laparoscopic procedures should be performed only by persons having adequate training and familiarity with laparoscopic techniques. Consult the medical literature relative to techniques, complications and hazards prior to performance of any laparoscopic procedure.
10. This product is for single use and is provided sterile. DO NOT RESTERILIZE.
11. Follow all of the recommended electrosurgical and laser manufacturers’ instructions and warnings while operating in these modes.
12. Gravity prime and perform all priming with the probe tip outside the patient
13. Irrigation fluid must have a specific gravity of approximately 1.
14. Grounding reliability can only be achieved when power supply is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade”.
15. X-Stream™ should be positioned so that it is not difficult to disconnect the device from the power source, in order to facilitate access.
16. The X-Stream™ controller should not be placed adjacent to or stacked with other equipment unless nominal operation of the X-Stream™ has been observed as it may cause a malfunction of the device.
17. Use special precautions regarding the use of X-Stream™,  X-Stream™ is to be used in EMC environment that are suitable for Group 1, Class A medical equipment. See EMC information provided in X-Stream™ Controller Operator’s Manual.

When passing laser fibers through probe – Warnings and Precautions:

1. CO2 laser energy systems are not compatible for use through the trumpet valve and probe tip.
2. A thorough understanding of the principles and techniques of laser surgical procedures is necessary to avoid injury to the patient, operator and operating room personnel.
3. Pathology and the surgeon’s choice will dictate laser tip configuration.
4. Proper eye wear is mandatory before activating the laser.
5. Use of this device with laser equipment is indicated only in those procedures for which the selected la s er fiber and laser system being used have been approved by the FDA.
6. To avoid damage to the laser fiber, do not expose tip until suction/irrigation probe has passed through the laparoscopic trocar.

BD-18106