VISION
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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)

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.

WIRELESS ADVANCED CONTROL FOOTPEDAL

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. 

SOVEREIGN® COMPACT PHACOEMULSIFICATION SYSTEM FOOTPEDAL

With open- and closed-toe varieties, the SOVEREIGN® Compact System Footpedal offers the flexibility and operator control to complement your phacoemulsification technique.

Available for the SOVEREIGN® Compact Phacoemulsification System.

FOOTNOTES

*When used with the WHITESTAR Signature® System.

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

Rx Only

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

Rx Only

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

Rx Only

INDICATIONS

The AMO 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 AMO 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 AMO. 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. AMO 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. AMO 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: AMO 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 AMO 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-AMO approved products with the WHITESTAR Signature® System, as this can affect overall system performance. AMO 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 AMO 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. AMO recommends using sterile non-pyrogenic water to clean the handpieces and accessories. STERILIZATION: CAUTION: AMO 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, AMO 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 AMO 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 AMO Technical Service representative to replace the batteries.

 

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

Rx Only

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 AMO 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 AMO 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. When lowering or raising the irrigation solution bottle to decrease or increase fluid flow and pressure, exercise extreme caution. Lowering the bottle too much can cause anterior chamber collapse. Raising the bottle too high can cause a deep or bulging chamber. Operating phacoemulsification without adequate flow may result in elevated temperature of the tip and subsequent damage to the eye tissue or could cause chamber collapse. Confirm that there is irrigation flow prior to initiating phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow by pinching off the irrigation sleeve assembly on the needle of the phaco handpiece. Should you momentarily lose power during a procedure, you will need to withdraw the handpiece from the eye. Release the footpedal to position 0 and when power is restored, re-select PROGRAM and press PRIME/TUNE or I/APRIME to reprime the fluids. BYPASS PRIME may be used. Reselect the function you are using (Phaco, I/A, Vitrectomy or Diathermy). It is very important that the electrical connectors on the handpieces are completely dry prior to connecting them to the SOVEREIGN® Compact System receptacles. You may receive a "Phaco Handpiece Ground Fault Error" message if the connector is wet. The ultrasonic handpiece is a very delicate instrument and should be handled with EXTREME care. If it is dropped or receives any other significant impact, it will not work properly. The ultrasonic titanium phaco tip should never touch any solid material while in use. Always flush the handpiece immediately following surgery. Handpieces may be extremely hot immediately after sterilization. Use care and caution when handling. VITRECTOMY:  CAUTION: The phaco and vitrectomy handpieces should never be activated with the tips in 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. Failure to properly attach the tubing to the appropriate vacuum or pressure source will affect the vitrectomy handpiece operation. Be sure to read the handpiece package insert for correct assembly and connection procedures. DIATHERMY: Upon entering diathermy mode, there should be an audible tone. Also, whenever diathermy power is applied, an audible tone should be heard. The diathermy cable should be checked periodically for damage. If the cable shows signs of damage, replace it immediately with the same type of cable. Use of other types of cables may affect the diathermy performance. During surgery, the diathermy output power should be as low as possible for the intended purpose. AMO recommends a 30% setting to start. The patient should not come into contact with ungrounded metal parts when diathermy is being used. The diathermy cable should be positioned in such a way that contact with the patient or other leads is avoided. If the handpiece is not functioning properly in the diathermy mode, replace it with the same type of handpiece. Power IV: Pole Do not exceed maximum weight of 11 kg (2.51 lbs.) on the IV pole bottle holder. Never handle the footpedal by its power cord.

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-AMO approved products with the SOVEREIGN® Compact System, may affect overall system performance and is not recommended. AMO 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.

CONTRAINDICATION AND ADVERSE EVENTS STATEMENT

Risks and complications may include broken ocular capsule or corneal burn.  Prior to use, please reference the SOVEREIGN® Compact Operator's Manual for more information on intended use, warnings, and precautions. US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner. The product may contain mercury. Please dispose accordingly to state, local or federal laws.

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