Biovision Technologies
NeedleView CH Instructions for Use July 2015
Instructions for Use
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WARNINGS: • The BioVision Technologies NeedleView CHTM Scope and instruments are provided sterile. • Inspect the scope and instruments for any evidence of damage prior to use. Pay particular attention for scratches on optical surfaces. Scratches can interfere with image quality. • Use caution when handling this device. • Single-use only. DO NOT REUSE.
BVTKIT82-34001 BioVision Technologies NeedleView CHTM 3.4 Scope Kit consists of 1 each: • NeedleView CH 3.4mm Scope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length) • 12F Cannula (4mm Inner Diameter) • 12F Dilator (4mm Diameter) • 14G X 127mm Tuohy Needle • 18G X 152mm Tuohy Needle • #11 Scalpel • Guidewire (70cm Length) • Hemostasis Valve Adapter (HVA) • Drape TM
Pack is supplied sterile Disposable: Intended for single use only.
Do not use if package or instruments are damaged.
BioVision Technologies, LLC. 221 Corporate Circle, Unit H Golden, CO 80401 USA 303-237-9608 Caution: Federal (USA) law restricts this device to use by or on the order of a licensed physician.
ATTENTION OPERATING SURGEON DESCRIPTION: The BioVision Technologies NeedleView CHTM 3.4 Kit consists of a fiber-optic based micro-endoscope with a working channel, a drape and supplementary instruments. All of these items are disposable, and for single-use only. The micro-endoscope is made to couple with a non-disposable system handpiece that contains a light source and camera, which is available separately. INDICATIONS FOR USE: This disposable epidural catheter is generally used to inject drugs into the epidural space so as to relieve pain. This is a composite medical device that combines an epidural catheter and an internal medical camera which can be inserted into the epidural space and take pictures of the inner body. CONTRAINDICATIONS: The NeedleView CH 3.4 is not indicated for long term use.
BVT93582-34001-D
POSSIBLE ADVERSE EFFECTS: • Infection following the procedure. • Introduction of foreign materials can result in an inflammatory response or allergic reaction. • Wound dehiscence. • Nerve damage. • Damage to tissue and/or bone near or around micro-endoscope when inserted into a surgical or natural opening. INSTRUCTIONS FOR USE: 1. Once the local anesthetic has taken effect, make a small incision using a number #11 scalpel. 2. Insert the Tuohy needle: 14G*5in into the patient until the needle is inside the epidural space. 3. Remove stylet from the Tuohy needle: 14G*5in. 4. Insert the Tuohy needle: 18G*6in into the Tuohy needle: 14G*5in. 5. Remove stylet from the Tuohy needle: 18G*6in. 6. Insert the guidewire through the Tuohy needle: 18G*6in a short distance to prepare for insertion of the introducer sheath and dilator. 7. Remove the Tuohy needle: 14G*5in and, Tuohy needle: 18G*6in, leaving the guidewire in place. Ensure that the guidewire is straight inside the patient. 8. Introducer sheath and dilator can now be introduced percutaneously over the guidewire. 9. Check the position of the introducer removes the dilator along with the guidewire. 10. Insert the NeedleView CHTM through the Introducer sheath. 11. Connect the Hemostasis Valve Adapter (HVA) to the Lure Lock of the NeedleView CHTM and remove air from working channel by injecting saline solution through the stopcock of HVA. (The valve on the HVA will prevent spillage.) 12. Once the NeedleView CHTM has been navigated to the desired location, drugs indicated for use in the epidural space may be used. 13. Remove the introducer sheath and NeedleView CHTM. STERILITY: The BioVision Technologies NeedleView CHTM Scope and instruments are sterilized by exposure to Ethylene Oxide (EO) gas. The scope and instruments are for one-time, single patient use only. Do not use any instrument from an opened or damaged package. Do not resterilize. Do not use past expiration date. DO NOT STEAM AUTOCLAVE the disposable micro-endoscope as it will be irreparably damaged. Cleaning of the handpiece: The handpiece (available separately) can be cleaned and disinfected with cleaning agents meant for the cleaning of electrical equipment. Follow manufacturer instructions. DO NOT use cleaning agents that are not compatible with plastics. DO NOT allow excessive moisture or liquids to come in direct contact with the handpiece. Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of a physician. NeedleView CHTM is the property of BioVision Technologies, LLC.