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DEVICE DESCRIPTION
The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system
PACKAGING CONTENTS
A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion.
INDICATIONS FOR USE
The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination
DIRECTIONS FOR USE
Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field
Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use
Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure
CONTRAINDICATIONS
The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques
WARNINGS
Contents supplied sterile. Do not use if sterile barrier is damaged
Do not use the GreenEgg™ if the device has been opened or damaged
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician
STORAGE
Store at room temp, avoid extreme temps
DISPOSAL
Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices
REUSE PRECAUTION STATEMENT
For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.
Endoglow, LLC
EP1000-30
In Commercial Distribution
- 00860001161618 ()
- 10860001161615 ()
- Length: 12.5 Inch
- Outer Diameter: 30 Millimeter
EP1000-30
- Colonic bougie
INTENDED USE/ CONTRAINDICATIONS
PremierPro™ Air Transfer Mats are indicated for patients:
Who are unable to transfer or turn by their own effort, both assisted and unassisted.
Whose size and weight present possible risks to caregivers involved in the transfer of the patient.
PRECAUTIONS & WARNINGS
Use two or more caregivers during patient transfers.
Do not use transfer mat until user manual is reviewed.
Do not leave patient unattended on inflated transfer mat.
Do not attempt to move patient on uninflated transfer mat.
The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).
AIR SUPPLY
Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3711
In Commercial Distribution
- 10818566019216 ()
- 00818566019219 ()
- Length: 39 Inch
3711
- Patient transfer system, powered
INTENDED USE/ CONTRAINDICATIONS
PremierPro™ Air Transfer Mats are indicated for patients:
Who are unable to transfer or turn by their own effort, both assisted and unassisted.
Whose size and weight present possible risks to caregivers involved in the transfer of the patient.
PRECAUTIONS & WARNINGS
Use two or more caregivers during patient transfers.
Do not use transfer mat until user manual is reviewed.
Do not leave patient unattended on inflated transfer mat.
Do not attempt to move patient on uninflated transfer mat.
The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).
AIR SUPPLY
Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3710
In Commercial Distribution
- 10818566019209 ()
- 00818566019202 ()
- Length: 34 Inch
3710
- Patient transfer system, powered
INTENDED USE/ CONTRAINDICATIONS
PremierPro™ Air Transfer Mats are indicated for patients:
Who are unable to transfer or turn by their own effort, both assisted and unassisted.
Whose size and weight present possible risks to caregivers involved in the transfer of the patient.
PRECAUTIONS & WARNINGS
Use two or more caregivers during patient transfers.
Do not use transfer mat until user manual is reviewed.
Do not leave patient unattended on inflated transfer mat.
Do not attempt to move patient on uninflated transfer mat.
The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).
AIR SUPPLY
Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3700
In Commercial Distribution
- 00818566019165 ()
- 10818566019162 ()
- Length: 28 Inch
3700
- Patient transfer system, powered