Summary of Safety Information

The ELLIPS® FX Phaco Handpiece is utilized during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments. The ELLIPS® FX Phaco Handpiece is designed as a reusable product and is supplied nonsterile. 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. Risks and complications may include broken ocular capsule, corneal burn and iris depigmentation. Consult with your eye care professional for a complete listing of contraindications and risks. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Important Safety Information

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. Consult with your eye care professional for a complete listing of contraindications and risks.

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, corneal burn, and iris depigmentation.  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.