LifeStent™ 5F Vascular Stent System

Intended Use:
The Hydro-Surg™ Plus Irrigator is designed to be used with the DAVOL™ Trumpet Valve and tip to provide controlled powered irrigation to, and aspiration of fluids/smoke from, the operative site during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage. Appropriate fluids include those which have a specific gravity of approximately 1 (e.g. saline).Additional specialty probe tips are available from DAVOL, including insulated and non-conductive tips for use with electrosurgery. Suction/irrigation probe tips, when included, have a non-reflective surface to help avoid laser beam reflection. With proper adapter, a laser fiber and laser fiber sheath can be passed through the probe handle and tip. Pathology and/or surgeon’s choice will dictate preference of suction/irrigation probe tip configuration.

Contraindications:

• Use of this device for hysteroscopy or for cavity distention is contraindicated.
• Use of this device for intra-abdominal irrigation is contraindicated whenever laparoscopy is contra-indicated. See operator’s manual of your laparoscope for absolute and relative contraindications.
• Use of electrosurgery instruments and electrode inserts with an uninsulated metallic tip is contraindicated.

Warnings:

• 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.
• Do not resterilize.
• Do not incinerate the batteries as this can cause a risk to the environment.
• Only remove batteries for disposal when procedure is completed. Batteries should never be replaced, recharged, put in backwards, or mixed with used or other battery types as these actions may cause explosion or leakage leading to personal injury or can cause a risk to the environment.
• As with any surgical procedure where extensive irrigation is utilized, unintended fluid uptake levels should be closely monitored by the attending physician.
• When using electrosurgery tips or electrode inserts, follow all instructions, warnings, precautions, and contraindications provided with these devices.
• Do not use in an oxygen-enriched atmosphere due to explosion hazard.
• Do not occlude suction tip side holes. If side holes become occluded, negative pressure at the tip may increase and cause tissue to be pulled into the tip potentially damaging tissue.
• If Hydro-Surg™ Plus Irrigator is used stacked with or adjacent to other equipment, Hydro-Surg™ Plus Irrigator should be observed to verify normal operation.

Precautions:

• If package is damaged or open, do not use product.
• The pump motor runs continuously when fluid is NOT present in the pump housing. Prolonged operation without fluid in the system may damage the pump motor and must be avoided. This could occur in two ways: 1.) if the pump is turned on prior to priming, turn pump “OFF” and see Step 5 for Instructions for Gravity Pri mi g the Pump; or, 2.) if air enters the pump after bag runs out of fluid, see Step 7 for Instructions for Repriming System in Case of Bag Change.
• Attach pump to I.V. pole before spiking irrigation bag since spike will not securely support pump while in use.
• Use of bottled irrigant is NOT recommended. Although bottles can be used, performance is significantly diminished by air that is pulled into the pump before it can be vented from the bottle.
• 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.
• 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.
• This product is for single use and is provided sterile. DO NOT REUSE.
• Follow all of the recommended electrosurgical and laser manufacturers’ instructions and warnings while operating in these modes.
• Install medical equipment according to the EMC information provided.
• Mobile RF communications equipment can effect medical equipment.

Warnings and Precautions:
WHEN PASSING LASER FIBERS THROUGH PROBE:

• Do not use CO2 laser energy systems as they are not compatible for use through the probe handle and tip.
• 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.
• Pathology and the surgeon’s choice will dictate laser tip configuration.
• Proper eye wear is mandatory before activating the laser.
• Use of this device with laser equipment is indicated only in those procedures for which the selected laser fiber and laser system being used have been approved by the FDA.
• To avoid damage to the laser fiber, do not expose tip until suction/irrigation probe has passed through the laparoscopic trocar.
• To avoid injury to the patient do not activate laser until tip is fully inserted and under visual control.

Intended Use:
The Hydro-Surg™ Plus Irrigator is designed to be used with the DAVOL™ Trumpet Valve and tip to provide controlled powered irrigation to, and aspiration of fluids/smoke from, the operative site during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage. Appropriate fluids include those which have a specific gravity of approximately 1 (e.g. saline).Additional specialty probe tips are available from DAVOL, including insulated and non-conductive tips for use with electrosurgery. Suction/irrigation probe tips, when included, have a non-reflective surface to help avoid laser beam reflection. With proper adapter, a laser fiber and laser fiber sheath can be passed through the probe handle and tip. Pathology and/or surgeon’s choice will dictate preference of suction/irrigation probe tip configuration.

Contraindications:

• Use of this device for hysteroscopy or for cavity distention is contraindicated.
• Use of this device for intra-abdominal irrigation is contraindicated whenever laparoscopy is contra-indicated. See operator’s manual of your laparoscope for absolute and relative contraindications.
• Use of electrosurgery instruments and electrode inserts with an uninsulated metallic tip is contraindicated.

Warnings:

• 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.
• Do not resterilize.
• Do not incinerate the batteries as this can cause a risk to the environment.
• Only remove batteries for disposal when procedure is completed. Batteries should never be replaced, recharged, put in backwards, or mixed with used or other battery types as these actions may cause explosion or leakage leading to personal injury or can cause a risk to the environment.
• As with any surgical procedure where extensive irrigation is utilized, unintended fluid uptake levels should be closely monitored by the attending physician.
• When using electrosurgery tips or electrode inserts, follow all instructions, warnings, precautions, and contraindications provided with these devices.
• Do not use in an oxygen-enriched atmosphere due to explosion hazard.
• Do not occlude suction tip side holes. If side holes become occluded, negative pressure at the tip may increase and cause tissue to be pulled into the tip potentially damaging tissue.
• If Hydro-Surg™ Plus Irrigator is used stacked with or adjacent to other equipment, Hydro-Surg™ Plus Irrigator should be observed to verify normal operation.

Precautions:

• If package is damaged or open, do not use product.
• The pump motor runs continuously when fluid is NOT present in the pump housing. Prolonged operation without fluid in the system may damage the pump motor and must be avoided. This could occur in two ways: 1.) if the pump is turned on prior to priming, turn pump “OFF” and see Step 5 for Instructions for Gravity Pri mi g the Pump; or, 2.) if air enters the pump after bag runs out of fluid, see Step 7 for Instructions for Repriming System in Case of Bag Change.
• Attach pump to I.V. pole before spiking irrigation bag since spike will not securely support pump while in use.
• Use of bottled irrigant is NOT recommended. Although bottles can be used, performance is significantly diminished by air that is pulled into the pump before it can be vented from the bottle.
• 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.
• 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.
• This product is for single use and is provided sterile. DO NOT REUSE.
• Follow all of the recommended electrosurgical and laser manufacturers’ instructions and warnings while operating in these modes.
• Install medical equipment according to the EMC information provided.
• Mobile RF communications equipment can effect medical equipment.

Warnings and Precautions:
WHEN PASSING LASER FIBERS THROUGH PROBE:

• Do not use CO2 laser energy systems as they are not compatible for use through the probe handle and tip.
• 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.
• Pathology and the surgeon’s choice will dictate laser tip configuration.
• Proper eye wear is mandatory before activating the laser.
• Use of this device with laser equipment is indicated only in those procedures for which the selected laser fiber and laser system being used have been approved by the FDA.
• To avoid damage to the laser fiber, do not expose tip until suction/irrigation probe has passed through the laparoscopic trocar.
• To avoid injury to the patient do not activate laser until tip is fully inserted and under visual control.