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Footpedals

FOOTNOTES

*When used with the WHITESTAR Signature® System.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE® PRO PHACOEMULSIFICATION SYSTEM

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INDICATIONS

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.

WARNINGS

All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system.

See Full Indications and Important Safety Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV PHACOEMULSIFICATION SYSTEM

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INDICATIONS

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.

SAFETY PRECAUTIONS

Read the following safety precautions and warnings carefully before you use the system in surgery. Do not use extension cords with your machine.

See Full Indications and Important Safety Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE® PHACOEMULSIFICATION SYSTEM

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INDICATIONS

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.

SAFETY PRECAUTIONS

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.

WARNINGS

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.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE SOVEREIGN® COMPACT PHACOEMULSIFICATION SYSTEM

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INTENDED USE

The SOVEREIGN® Compact Cataract Extraction System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. 

SAFETY PRECAUTIONS

The SOVEREIGN® Compact System is equipped with 3-prong plugs which should be plugged into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT defeat or remove the ground pin. Do not use extension cords with your machine, and do not overload your AC electrical outlet. If the cord or plug is damaged, do not continue using the instrument. Electric shock or fire hazard may result. Call JJSV to order a new cord. The instrument has ventilation openings to allow the release of heat generated during operation. If these openings are blocked, heat build up can cause system failures which may result in a fire hazard. Do not try to roll the SOVEREIGN® Compact System cart on deep pile carpets or over objects on the floor such as cables and power cords. Do not place the instrument on uneven or sloped surfaces. Do not use disposables, accessories or other surgical instruments that are not designed for this system. Use only parts recommended by JJSV to achieve optimum performance and safety. Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder. To protect the patient from contaminated fluids or handpieces, use only sterile tubing sets, sterile irrigation fluid, and sterile handpieces. Use caution when extending, retracting or swiveling the Mayo stand articulating arm. Stay clear of hinged hardware. Use caution when handling handpieces with sharp edges or pointed tips. When using OPO65, always replace the drain bag with a clean bag between cases. Electrode cables and accessories should be regularly inspected for possible damage to the insulation. This includes the Diathermy, EVIT and Phaco cables.

CAUTIONS

CAUTION: Do not clean the phaco handpiece with any type of ultrasonic cleaning device; it will damage the piezoelectric crystals. CAUTION: Do not touch the edge of the sink or any hard object with the cutting tip of the vitrectomy handpiece – it can be easily damaged, and if very expensive to repair. CAUTION: Never attempt to straighten a bent needle. This will produce a broken tip when phaco is applied. CAUTION: The phaco and vitrectomy handpieces should never be activated with the tips in the air. Doing so will drastically reduce the useful life. If power is to be introduced to the phaco or vitrectomy handpieces, the tips should be in a test chamber filled with irrigating solution, in a container of irrigating solution, or in the patient's eye. CAUTION: If a tone is not heard when the foot pedal is pressed and volume adjustment is unsuccessful, the mode is not functioning properly. CAUTION: Do not sterilize the handpiece prior to performing the cleaning procedures CAUTION: Gas sterilization is not recommended.

WARNINGS

All personnel should read and understand the instructions in this manual before the system is used. Failure to do so may result in the improper operation of the system. This device is only to be used by a trained licensed physician. DO NOT attempt to use the system if it fails to perform properly as stated in this manual. DO NOT use the system in the presence of flammable anesthetics, or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents, as fire could result. This unit may interfere with any cardiac pace maker fitted to the patient, therefore obtain advice from the device manufacturer prior to such use. The patient should not come into contact with metal parts which are grounded or have appreciable capacitance to ground. The use of an antistatic mat for this purpose is recommended. Monitoring electrodes or other types of equipment should be placed as far from those of the SOVEREIGN® Compact System as possible. High current limiting devices are recommended for the protection of such systems. The output power selected should be as low as possible for the intended purpose. Although this unit complies with all EMI standards and requirements, it is possible that this unit could interfere with and may adversely affect the operation of other types of electronic equipment Skin to skin contact on the patient, e.g., between the arms and the torso is not recommended. Note: The unit contains no neutral electrode. Note: The diathermy output is bipolar. Note: It is recommended that the condition of all inter-connecting and handpiece cables be checked on a regular basis. Risk of burns and fire. Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. Renew electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect power before servicing. Not recommended for use in condensating environment.If exposed to condensating environment, allow system to equilibrate to typical operating room conditions prior to use. This HIGHFREQUENCY(HF) SURGICAL EQUIPMENT is specified for use without a NEUTRAL ELECTRODE. Failure of the HIGH FREQUENCY(HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. All non-sterile accessories should be sterilized 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. If any questionable characteristics are noted, use a backup handpiece for surgery. Use of contaminated or damaged system accessories may cause patient injury. Reflux is a user selectable switch option. In the event of captured tissue and vacuum present, deselection of reflux requires the user to release the foot pedal to position 0 to open the vent valve. Use of non-JJSV approved products with the SOVEREIGN® Compact System, may affect overall system performance and is not recommended. JJSV cannot be responsible for system surgical performance if these products are utilized in surgery. 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 may be compromised.

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