Cystoscope / Hysteroscope
The NeoScope Video Endoscopic System consists of three main components:
- Digital Video Endoscope
- Video Module & Software
- Laptop / Tablet Computer
Digital Video Endoscope (Rigid)
The Digital Video endoscope design incorporates a CMOS imaging sensor and 4 ea built-in LED ( Light Emitting Diodes) mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB 2.0 Connector at the proximal end. The distal end of the endoscope containing CMOS sensor and LEDs, is protected by sealed optical glass window and the proximal end of the tubular structure is housed into a medical grade ABS molded handle. The Neoscope endoscope is provided sterile for Single use only and does not require cleaning , reprocessing or re-sterilization. The Neoscope Endoscope is available as a 5.0mm OD diagnostic device or 7.5mm OD as an operating device with 5 Fr working channel. The Neoscope can be utilized as a Cystoscope or Hysteroscope by a trained physican for diagnostic and operating procedures, using commercially available, video capture module and portable laptop / Tablet computer.
Video Capture Module & Software :
The commercially available, Video Capture Module and Video Processing Software, commonly used to covert Analog video (VCR) tapes & other media into Digital files or DVD are supplied by El Gato company for use with majority of commercial computers. The Video Capture module with software are not patient contact items and can easily be connected / loaded to the Laptop/ Tablet computer. The Video Capture Module receives the analog signal from CMOS sensor of the endoscope and coverts it into digital video signal recordings. The El Gato software is used to format the digital video recordings into commonly used video format files, including Quick Time, iTune, i Movie, window Media & You Tube.
Portable Laptop / Tablet Computers:
The Portable Laptop / Tablet Computer can be used as a video monitor and recording / storage device to view, record, edit, store and transfer /transmit the video files. The Digital Video Endoscope and Video Capture Module can be connected to majority of commercially available Laptop /Tablet computer using standard USB 2.0 connecting cables. If necessary, additional USB connecting cable can also be used.
- Note: The Laptop / Tablet Computer is commercially available product (Mac or Windows based Operating System) (Not supplied by Neoscope)
NeoScope Product Models :
(A) Diagnostic & Operating Video NeoScopes: (Rigid)
Urology
* Diagnostic Neo-CystoScope (Model # NCR50S)
Gynecology
* Diagnostic Neo-HysteroScope ( Model # NHR50S)
Laparoscopy
* Diagnostic Neo-LaparoScope ( Model # NLR 50S)
* Operating Neo-LaparoScope (Model #NLR 105S)
* Operating Neo-LaparoScope (Model # NLRA105S) w/Articulating Tip
(B) Diagnostic & Operating Video NeoScopes: (Flexible)
[toggle title=”NCF75S – Operating NeoFlex-Cystoscope w/Articulating Tip” state=”closed”] 7.5mm Diameter [/toggle]
[toggle title=”NHF75S – Operating NeoFlex-Hysteroscope w/Articulating Tip” state=”closed”] 7.5mm Diameter [/toggle]
[toggle title=”NLF105S – Operating NeoFlex-Laparoscope w/Articulating Tip” state=”closed”] 10.5mm Diameter [/toggle]
[toggle title=”NNF105S – Operating NeoFlex-Nephroscope w/Articulating Tip” state=”closed”] 10.5mm Diameter [/toggle]
[toggle title=”NEF75S – Operating NeoFlex-ENTscope w/Articulating Tip” state=”closed”] 7.5mm Diameter [/toggle]
[toggle title=”NGF110S – Operating NeoFlex-Gastroscope w/Articulating Tip” state=”closed”] 10.5mm Diameter [/toggle]
[toggle title=”NCF130S – Operating NeoFlex-Colonoscope w/Articulating Tip” state=”closed”] 13.0mm Diameter [/toggle]
(C) NeoScope Video Capture Accessories:
[toggle title=”NVMM – Video Module & Software (Mac)” state=”closed”] Compatible with Mac [/toggle]
[toggle title=”VMW – Video Module & Software (Windows)” state=”closed”] Compatible with Windows [/toggle]
[toggle title=”USB60 – USB 2.0 Connecting cable” state=”closed”] 6 feet [/toggle]
[toggle title=”USB12 – USB 2.0 Connecting cable” state=”closed”] 12 feet [/toggle]
*For price and delivery time for above products, please contact Customer Service at (310) 766-0750
Indications For Use:
The NeoScope ( Cystourethroscope/ Cystourethroscope/ Cystonephroscope) Digital Video System (which includes the Digital video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures.
The Neoscope (Hysteroscopce) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.
Contraindications:
The NeoScope Video endoscope for Cystourethroscopy is contraindicated for patients with Urinary Tract Infection ( UTIs).
The NeoScope Video endoscope for Hysteroscope is contraindicated for patients with current or recent pelvic infection, vaginitis, cervicitis, uterine perforation, uterine cancer and pregnancy.
Warnings:
The NeoScope –Digital Video Endoscopic System is intended for use by trained physicians only. The device should not be used until the physician is familiar with the instructions for use, assembly and care of the device. Device instruction manual should be carefully studied and be available to the surgical / endoscopic team during the procedure. It is essential to follow the instructions contained in the instruction manual pertaining to the devices used in the procedure, with particular attention given to the warnings and cautions. Care must be exercised during endoscopic procedure or the video endoscope may create perforation, infection or damage to the endoscope .Care must be exercised during endoscopic insertion so as to avoid damage or injury to the surrounding tissue. Possible injuries may include unintended tissue damage beyond the zone of target tissue, compromised vasculature, injury to underlying organs or surrounding tissue not targeted for the treatment. Endoscopic visualization or other imaging diagnosis must be performed during the procedure to verify that there is no potential damage to the other tissue structure or body organs. After the endoscopic procedure, the patient should be counseled for potential side effects and emergency instructions.
Video endoscope is supplied Sterile using an ethylene oxide (ETO) process. Do not use, if sterile barrier is damaged. If damage is found, please DO NOT USE. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization 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 disease(s) from one patient to Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Cautions:
- Recommended for Single (one time) use only.
- Bending or kinking during or prior to placement could damage integrity of the endoscope.
- If resistance is encountered during advancement or withdrawal of the microsurgical instrumentation into working channel of the Video endoscope, STOP. Do not continue without first determining the cause of the resistance and taking remedial action..
Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.
Inspection and Assembly:
3.1 Use aseptic technique when removing the NeoScope ™ Digital Video Endoscope from the package. Prior to use, carefully inspect the device for any visible signs of damage. DO NOT USE the device if it appears to be cracked, flawed, or otherwise damaged. DO NOT BEND OR MANIPULATE THE DEVICE.
3.2 Carefully remove the Video module from the Package. Prior to use, carefully inspect the device for any visible signs of damage. DO NOT USE the device if it appears to be cracked, flawed, or otherwise damaged. Remove the El Gato software disc from the package, install and launch the appropriate version of software on Mac / Window laptop / tablet computer. Optionally, the software can also be downloaded from El Gato website (Elgato.com).
3.3 Connect the Video module with USB connector to Laptop / Tablet computer.
Use a male / female USB extension cord , if necessary to provide additional length between laptop / tablet computer and Video endoscope.
3.4 Using aseptic technique in sterile field, connect the video endoscope to video module, using male/ female USB 2.0 connector.
3.5 Launch El Gato application on the laptop / tablet computer and follow the on screen instructions to record, edit, store and format the video recording of the procedure. Transfer or transmit the video recording to patient file or other device.
Diagnostic & Surgical Procedure:
4.1, The NeoScope Video endoscopic system can be used for various endoscopic procedure for treatment of Urological, Uro–gynecological or Gynecological disorders, using appropriate model of Video endoscope.
4.4 Prepare the patient and operating work area. Select the appropriate model of NeoCystoscope or NeoHysteroscope for diagnostic or therapeutic procedure. Attach irrigation / aspiration tubing using lure lock connection mounted on the proximal end of the video endoscope handle. Make sure the lure lock connection is secure. The working channel of the operating Video Endoscope model including NeoCystoscope , NeoHysteroscope , NeoFlex Cysoscope and NeoFlex Hysteroscopce can be used for suction / irrigation of fluid and 5 Fr microsurgical instruments for various Cystoscopic and Hysteroscopic procedures.
STERILIZATION:
The NeoScope™- Digital Video endoscopeis provided in sterile packaging and is intended for single use only. Do not use if the product sterility is compromised due to damaged package. It is recommened that product be stored in a cool dry storage facility. The NeoScope™ video endoscope and packaging should be properly disposed of at the end of the procedure according to hospital/clinic policy. Do not attempt to re-sterilize
GENERAL WARNING:
The The NeoScope™- Digital Video Endoscopic Systemis intended for use only by physicians. The user of the device should be thoroughly trained in its use and the applicable medical procedures. Use of these devices should no be undertaken until the user has fully familiarized himself with the instructions for use, assembly and care. Equipment instruction manuals should have been carefully studied and be available to the surgical team during the procedure. It is essential to follow the instructions contained in instruction manual pertaining to devices used in the procedure, with particular attention given to the warnings and cautions. Care must be exercised during surgical procedure, or the instrument may potentially create perforation, infection, device damage or breakage. After the surgical procedure, the patient should be counseled for potential side effects, if any and emergency instructions.
********* LIMITED WARRANTY********
Neoscope LLC warrants the NeoScope™- Digital Video Endoscopic Systemto be free from defects in material and workmanship for a period of 30 days from the day of shipment when properly installed, maintained, and used for its intended purpose. This warranty applies only to the original purchaser, and only so long as the equipment is used in the country to which Nieoscope LLC originally shipped it. This warranty is null and void if the user attempts to reuse, resterilize, or modify the device in any way. If after examination by Neoscope’s Service Representative, any portion of the product is found to be defective within the period described above, and Neoscope LLC is satisfied that the failure was due to defective materials and /or workmanship, NeoScope LLC’s will, at its option, replace the defective product without charge.
THIS EXPRESS WARRANTY ABOVE IS THE SOLE WARRANTY OF OBLIGATION OF NEOSOPE LLC AND THE REDEMY PROVIDED ABOVE IS IN LIEU OF ANY AND ALL OTHER REDEMIES.THERE ARE NO OTHER AGRREEMENTS, GUARANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NEOSCOPE LLC. SHALL HAVE NO LIABILITY WHATSOEVER FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGE ARISING OUT OF ANY DEFECT, IMPROPER USE, OR UNAUTHORIZATION SERVICE OR REPAIR.
Prior to the return of the product, or any portion thereof, the NeoScope LLC representative must be consulted. If return of the device/ instrument is deem necessary, a Returned Material Authorization number will be assigned. This number must be recorded on the outside of the shipping container and on the return packing list. Please contact
Customer Service Dept.
Neoscope LLC (Neoscope2020.com)
637 Sand Dollar Rd.
Watsonville , CA 95076 U.S.A
Tel.: (310) 766-0750