Aesculap Long and Short Ventriculoscope Systems Instructions for Use

Size: px

Start display at page:

Download "Aesculap Long and Short Ventriculoscope Systems Instructions for Use"

Lenard Stevens
5 years ago
Views:

1 Aesculap Long and Short Ventriculoscope Systems Instructions for Use INDICATIONS FOR USE Aesculap s short and long ventriculoscopes and associated instruments are designed for visual orientation and therapeutic procedures within the ventricular system, such as vetriculostomies, biopsies and removal of cysts, tumors and other obstructions. The use of the ventriculoscopes or the associated instruments for tasks other than those for which they are indicated will usually result in damaged or broken instruments. CONTRAINDICATION Use is contraindicated in patients with, or suspected of having, Creutzfeld Jakob Disease (CJD). HOW SUPPLIED The ventriculoscopes and associated instruments are provided non-sterile, and must be sterilized / disinfected prior to use according to the procedures outlined in this document. The ventriculoscope systems are available in both a long version (FF370R) and short version (FF372R). The ventriculoscope systems consists of a working cannula, four obturators (two for irrigation and overflow channels, an obturator for the working channel, an obturator for the endoscope channel) and an endoscope. Associated instruments consist of monopolar and bipolar electrodes as well as flexible instruments with working distal tips (e.g. scissors, graspers). The system is displayed in Figure 1 below: KEY #1 = Ventriculoscope, working channel #2 = Right channel w/ obturator #3 = Left channel w/ obturator #4 = Working channel w/ obturator #5 = Endoscope channel / Obturator #6 = Locking lever #7 = Endoscope Note: The Long Ventriculoscope has valves on the obturator channels. The Short Ventriculoscope has no valves. Figure 1 Long Ventriculoscope FF372R PRECAUTIONS Do not use the ventriculoscope if the working channel is bent or curved. The Ventriculoscope working channel and obturators are marked with matching serial numbers. These components must stay together as a set. Inspect each instrument before each use for bent, cracked or worn parts. Do not use the instrument if a defect is found. When introducing or removing the instruments through the channels, proceed carefully and ensure that the working tips are in the closed position. Do not exert excessive force on the instruments as this may damage the working tips. Do not insert the 30º endoscope until the working channel is in a fixed position. The 30º endoscope projects slightly from the tip and may cause injury if inserted prematurely. To avoid contaminating the instrument, do not touch the eyepiece with the mask or face during viewing. Use a camera for viewing to avoid this potential risk. Do not mount the camera until the endoscope has been locked in the working cannula. The eyepiece connects easily through a C-mount to a camera system. If the scope is connected to a camera system, drapes should be employed for sterile coverage. To focus, turn the adjusting ring on the eyepiece until the object appears clear to the eye or monitor. Disconnect the camera from the endoscope before withdrawing the scope from the working cannula.

2 WARNINGS Only qualified surgeons and physicians should use the ventriculoscope. It is recommended to use a fixation device, such as a retractor, to stabilize the ventriculoscope body to prevent injury or pressure on the brain tissue. The long ventriculoscope system must be inserted into a stereotactic frame or retractor for stabilization. The short ventriculoscope can not be put into a stereotactic frame, it must be placed in a retractor. When light source is on, do not allow the endoscope tip to remain in prolonged contact with brain tissue. Infusion of fluid into the cranial cavity without proper venting may cause intracranial hypertension. During infusion of irrigating fluids, monitor the patient and device closely to make sure that the outflow paths do not become obstructed. Otherwise, increased cranial pressure may result. For Long Ventriculoscope (FF370R) Only: The valves on the working and overflow channels must be left in the open position before connecting to any infusion system. (note: the short ventriculoscope FF372R has no valves). Electrosurgery Warnings Do not perform electrosurgery in the presence of flammable anesthetics or other flammable gases, fluids or objects, or in the presence of oxidizing agents, as fire could result. When using electrosurgery, keep the voltage/power as low as possible to achieve the desired effect. The user should only activate the device when it is in contact with the target tissue or is in a position to deliver energy to target tissue by fulguration. Spray coagulation CAN NOT be performed when using the ventriculoscope systems. Do not exceed 50W output of the HF device when performing monopolar contact coagulation. When using a HF electrode simultaneously with a flexible instrument, be sure to maintain the greatest possible distance between the working tips. When activating the electrosurgical unit simultaneously with irrigation, the electrosurgical energy path may alter away from the target tissue. NOTES ON USE Before each use, examine the tip of the ventriculoscope to ensure that the obturators are correctly inserted and form a smooth, circular distal end (see Figure 2). Figure 2 The obturators and the instruments must be inserted and removed carefully from the working channel. Do not exert any unnecessary force on the instruments or parts. IMPORTANT Obturators for irrigation, overflow and working channels The obturators (see #2 and #3 in Figure 3) are marked right (R) and left (L) at the cap-end and must not be interchanged. Insert each obturator by grasping the distal end and carefully inserting it into the matching R or L channel in the ventriculoscope. The working channel (#4) has its own obturator. While inserting the obturator, the last 5mm may require rotating the obturator until it fully seats into the channel. The groove in each obturator (#2. #3, #9) must align with the internal pin in the main body of the ventriculoscope. Do not force obturator into channel either by rotating nut #9 or any other means. Rotate the nut (#9) 90 to secure placement. Figure 3 Long Ventriculoscope FF370R

3 Endoscope/Obturator When inserting the endoscope or obturator in Figure 4 ensure that the groove (#10) located on the endoscope or obturator is aligned with the peg on the ventriculoscope. When aligned and the endoscope or obturator are inserted completely, turn locking lever (#8) clockwise 30. Figure 4 Long Ventriculoscope FF370R CARE AND HANDLING The procedures outlined below should be followed to ensure safe handling of biologically contaminated instruments. PRE-CLEANING Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. Decontamination process should begin immediately after completion of the surgical procedure. Dismantle the ventriculoscope into its individual parts after each use. Instruments having more than one part or piece must be disassembled to expose all surfaces to the cleaning process. Retain all parts to facilitate reassembly. Using a steady stream of lukewarm/cool water (below 110º), rinse each instrument thoroughly to remove gross debris. Segregate the endoscope with optical elements for separate, careful cleaning. The instructions below can be used to clean endoscopes and instruments: CLEANING Hand wash using a low-sudsing, neutral ph (ph 7-9) protein dissolving detergent. Follow manufacturers' directions regarding concentration, temperature, contact time and reuse. Totally immerse instruments in the cleaning solution to prevent aerosolization. Ensure that all surfaces, including inner channels, lumen and openings come in contact with the solution. Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other bodily fluids. Do not exceed two hours soaking in ANY solution. Tools Use appropriate-sized, soft nylon brushes to clean the instruments/parts. A small brush (cat. no. PF 893) is provided with the ventriculoscope and can be used to clean the channels. Glass surfaces on optical elements should be cleaned with cotton pads dampened with 70% alcohol. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents. Ultrasonic Cleaning Do not place optical elements, such as endoscopes, in an ultrasonic cleaner. DECONTAMINATION - DISINFECTION Select a high-level disinfectant (examples include the glutaraldehyde-family of disinfectant products). Follow the cleaning agent s recommended directions regarding concentration, temperature, contact time and solution re-use. Do not use high acid (ph 4 or lower) or high alkaline (ph10 or higher) products for disinfection, such a bleach and bi-chloride of mercury. Warning: The use of glutaraldehyde-type disinfectants does not sterilize the products; endoscopes must be sterilized by EtO or steam, as outlined in the section Sterilization. Completely immerse the instruments in the disinfecting solution, including all parts and shafts.

4 Force solution into all areas and cavities. Use a syringe-like device or pulsating water jet to flush interior channels. RINSING Thoroughly rinse the instruments with de-ionized or distilled water to remove all traces of debris, disinfecting or cleansing agents. Make sure that all parts are thoroughly rinsed. USE STERILE WATER ON THE FINAL RINSE. Place instruments at an angled or vertical position (45º - 90º) and allow to drain completely. DRYING Instruments must be thoroughly dried to remove residual moisture before they are stored. Use a soft, absorbent towel/cloth to dry external surfaces. Use compressed air or a 70% alcohol rinse to aid in the drying process. LUBRICATION Each time after cleaning and prior to sterilization, moving parts and joints should be oiled with a non-silicone, anti-microbial, water soluble instrument lubricant (i.e. Aesculap s Sterilit JG600). DO NOT USE MINERAL OIL, SILICONE SPRAYS AND PETROLEUM-BASED LUBRICANTS. STERILIZATION Ventriculoscope, Rigid Scopes and Associated Instruments: The use of gravity or "flash" sterilization is not recommended 1. Sterilization may be accomplished by EtO or steam. The minimum recommended sterilization parameters are: Method: Temperature: Wrapped or in a SterilContainer : Pre-Vacuum: 270 F 4 minutes Ethylene Oxide (EtO) F 120 minutes (minimum) with 10/90% HCFC by weight or 100% EO; Chamber Humidity 40-60%; Gas Concentration 600mg/L; aeration of 8 hours minimum. Other sterilization cycles may also be suitable. However, individuals or hospitals not using the recommended methods are advised to validate any alternative method using appropriate laboratory techniques. 2. Sterrad Sterilization Process: The Endoscopes (only), in the Long and Short Ventriculoscope systems, are compatible, material and process, with the Sterrad process. Follow the Sterrad System Manufacturer s recommendations when processing this device. Use of a biological indicator is recommended to confirm effective sterilization. WARNING: Endoscopes CANNOT be Flash Sterilized. Hot endoscopes are very sensitive to shocks and vibrations. Do not suddenly expose hot endoscopes to cold after autoclaving. TESTING AND PREPARATION FOR STORAGE WARNING: Use of damaged endoscopes may increase the risk of tissue trauma, infection and length of operative procedure. Mechanically test the working parts (lens and fiber optic system) to verify the endoscope performs correctly. If turbidity or cracks in the lens are observed or light output is reduced, do not use the endoscope and return it to Aesculap for repair. Visually inspect the instruments. Check for nicks, misalignment, burrs or bent tips. Examine insulated instruments for integrity; observe for cuts, gouges or any exposed metal. Reassemble all component and moving parts. As needed, lubricate movable parts with a non-silicone, anti-microbial, water soluble instrument lubricant. Mechanically test the working parts to verify that each instrument performs correctly. STORAGE When not in use, store the ventriculoscope and the associated instruments in a clean, dry and protected area. Take precautions to prevent tip breakage. Instruments should be stored in areas which provide protection from extreme changes in temperature and humidity.

5 MAINTENANCE AND REPAIR 1. Repair of the instruments by parties other than Aesculap will void the warranty. 2. If the instruments require repair or maintenance, return the instruments in the Aesculap Instrument Repair (A.I.R.) box or other sturdy box with adequate foam, bubbles or other packaging material to protect the instruments. If the working channel requires repair, the obturators must also be returned. 3. Send your instruments for repair to: Aesculap, Inc. 615 Lambert Pointe Dr. Hazelwood, MO Attn.: Aesculap Technical Services or call the Repair Hotline at Endoscopes and instruments returned to Aesculap for repair must have a statement which testifies that each instrument has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in a cleaning charge and delayed processing of your instrument repair AIC

The A-Space SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental fixation is used.

Instructions for Aesculap Implant Systems A-Space SIBD Spinal System Indications The A-Space SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental