Summary of Safety Information

The WHITESTAR SIGNATURE System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. Risks and complications may include broken ocular capsule or corneal burn. Consult with your eye care professional for a complete listing of contraindications and risks. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Intended Use

The WHITESTAR SIGNATURE System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract surgery. Risks and complications may include broken ocular capsule or corneal burn. Consult with your eye care professional for a complete listing of contraindications and risks.

Safety Precautions

Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR SIGNATURE™ System in surgery.

• The WHITESTAR SIGNATURE™ System is equipped with 3-prong power plug which must be plugged 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.
• Do not use extension cords with your system.
• Do not overload your electrical receptacle (outlet).
• If the cord or plug is damaged, do not use the instrument. An electric shock or fire hazard can result. 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. If the openings are blocked, heat build-up can cause system failures which can result in a fire hazard.
• Do not try to move the WHITESTAR SIGNATURE™ 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 footpedal cords.
• Do not try to lift the WHITESTAR SIGNATURE™ System cart.
• 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 operate the WHITESTAR SIGNATURE™ 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 cassettes, sterile irrigation fluid, and sterile handpieces
• 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 cassette between cases.
• Wrap the excess power cord neatly around the cord wrap on the back of the console.
• Proper handling and disposal methods for biohazards must be used when you dispose of the tubing cassette, Mayo stand drape and monitor drape.

Warnings and Cautions

General:

• All personnel who might operate this equipment must read and understand the instructions in this manual before the system is used. Failure to do so might result in the improper operation of the system. This device is only to be used by a trained licensed physician.
• The fluid level in the balanced salt solution bottle must be monitored by the surgical nursing staff. The result of a low bottle or an empty bottle affects the fluid balance and the intra-ocular pressure (IOP) while aspirating. The low or empty bottle can result in:
• The inadvertent chamber shallowing or collapse
• The Aspiration of tissue
• An ultrasonic wound heating commonly called wound burn (extreme case). The surgical staff must monitor the fluid level at all times.
• 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 flammable anesthetics, or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents, as a fire could result.
• This unit might interfere with any cardiac pacemaker fitted to the patient; therefore qualified advice must be obtained prior to such use.
• The patient must 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.
• Proper handling and disposal methods for biohazards must be used when you dispose of the tubing cassette, mayo stand drape and monitor drape. WARNING: Monitoring electrodes or other types of equipment must be placed as far from those of the WHITESTAR SIGNATURE™ System as possible. High current limiting devices are recommended for the protection of such systems. Needle monitoring electrodes are not recommended.
• 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.
• Although 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.
• Skin to skin contact on the patient, for example, between the arms and the torso is not recommended. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any 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 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. WARNING: Remove the power cord from the power outlet when the equipment is not in use. WARNING: Do not obstruct the power outlet so that the power cord can be readily removed, as needed.
• 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.
• This HIGH FREQUENCY (HF) SURGICAL EQUIPMENT is specified for use without a NEUTRAL ELECTRODE. WARNING: 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. WARNING: Sterility assurance is the responsibility of the user. All non-sterile accessories must 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 can cause patient injury.
• Use of non-AMO approved products with the WHITESTAR SIGNATURE™ System, can affect overall system performance and is not recommended. AMO cannot be responsible for system surgical performance if these products are utilized in surgery.

Vitrectomy

• CAUTION: The phaco handpiece and vitrectomy cutter must never be activated with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If power is to be introduced 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

• CAUTION: Never attempt to straighten a bent needle. This might produce a broken tip when ultrasound is applied.
• CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures.
• CAUTION: Gas sterilization is not recommended.
• 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

Footpedal

WARNING: NEVER handle the footpedal by the cable

WARNING: Use only NiMH type batteries in the Advanced Control Pedal

Diathermy

CAUTION: If a tone is not heard when the footpedal is pressed and volume adjustment is unseccussful, the mode is not functioning properly. Refer to Operator’s Manual.

Remote control

WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your AMO Technical Service representative to replace the batteries

Contraindication and Adverse Events Statement

Risks and complications may include broken ocular capsule or corneal burn.  Please reference the Whitestar Signature Operators 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.