Feel The Control
Our selection of phacoemulsification footpedals is designed to maximize your control. With options to fit each of our phaco systems, there’s a pedal for your OR style and technique. (Pictured: Advanced Linear Pedal)
Engineered for comfort and responsiveness, the Advanced Linear Pedal offers exceptional flexibility to support your workflow.
- Enables easy, on-demand transition between peristaltic and venturi pump modalities
- Connect wirelessly to the system via Bluetooth® Connection
- Customize and save preferred settings
Available for the WHITESTAR SIGNATURE® PRO Phacoemulsification System.
Merging precision with ease of use, the Advanced Control Footpedal helps deliver efficient performance for compatible phaco systems.
- Ensures easy-to-use, precise performance
- Enables on-demand transition between peristaltic and venturi pump modalities*
- Connects to the system via Bluetooth® Connection to eliminate OR clutter
Available for the WHITESTAR Signature® Phacoemulsification System.
*When used with the WHITESTAR Signature® System.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE® PRO PHACOEMULSIFICATION SYSTEM
The WHITESTAR SIGNATURE® PRO System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.
All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV PHACOEMULSIFICATION SYSTEM
The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.
Read the following safety precautions and warnings carefully before you use the system in surgery. Do not use extension cords with your machine.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE® PHACOEMULSIFICATION SYSTEM
The Johnson & Johnson Surgical Vision, Inc. WHITESTAR Signature® Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.
Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR Signature® System in surgery. Risks and complications may include broken ocular capsule or corneal burn. The system comes equipped with 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call JJSV customer service to order a new cord. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures which can result in a fire hazard. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack between cases.
Read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device. The surgical staff must monitor the balanced salt solution bottle height and fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in: Inadvertent chamber shallowing or collapse, Aspiration or abrasion of the iris or other tissue, An ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects, and oxidizing agents. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, mayo stand drape, and monitor drape. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR Signature® System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). The output power selected must be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not use non-JJSV approved products with the WHITESTAR Signature® System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery. VITRECTOMY: CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. PHACO HANDPIECE SETUP CAUTION: Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. CAUTION: Do not clean the phaco handpiece with any type of ultrasonic cleaning device; the cleaning device can damage the piezoelectric crystals. WARNING: Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece can become compromised. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If the handpiece is dropped, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information or replacement handpiece. WARNING: Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. Use a backup handpiece for surgery if there are any questionable characteristics of the handpiece. Use of contaminated or damaged system accessories can cause patient injury. WARNING: The handpiece can deteriorate with the use of balanced salt solutions. Balanced salt solution tarnishes and pits metal. Proper cleaning of the instruments prolongs their useful life. JJSV recommends using sterile non-pyrogenic water to clean the handpieces and accessories. STERILIZATION: CAUTION: JJSV does not recommend gas sterilization. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. Do not place the storage cases provided in an autoclave. WARNING: Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. In addition, JJSV recommends a terminal sterilization cycle in the autoclave after the final case of the day. This cycle must include a drying cycle to remove moisture from the tubing and handpieces for storage. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If you drop the handpiece, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information for the handpiece or a replacement handpiece. DIATHERMY: CAUTION: If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly. PRIME/TUNE: WARNING: If you do not properly prime the IA tubing, errors can occur. CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. REMOTE CONTROL WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your JJSV Technical Service representative to replace the batteries.