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Important Safety Information

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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.

WHITESTAR Signature<sup>®</sup> Phacoemulsification System

The WHITESTAR Signature® System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery.

The WHITESTAR Signature® System represents a breakthrough in easy lens removal technology, from the company that has pioneered virtually every major breakthrough in phacoemulsification in the past two decades.

Only the WHITESTAR Signature® System combines the safety of revolutionary FUSION® Fluidics with the optimized cavitation of WHITESTAR® Technology. The integration of these technologies creates the versatility needed to remove both hard and soft lenses.

FUSION® Fluidics

FUSION® Fluidics provides increased chamber stability. It anticipates intraocular changes and proactively adjusts, so chamber stability can be maintained— even at higher vacuum and flow settings. Based on pre-set specifications, FUSION® Fluidics adapts to changes in vacuum immediately and automatically.

  • FUSION® Fluidics surge-prevention technology allows
    the use of high vacuum and flow settings to reduce
    phaco time and increase efficiency
  • Improves chamber stability by anticipating
    occlusions and preemptively adjusting vacuum
    before occlusion breaks
  • Provides precise, low-flow parameters for
    complicated cases
  • One-step, auto-loading FUSION® Fluidics cassette
    decreases turnover time

Wireless Advanced Control Pedal

The Wireless Advanced Control Pedal offers you the freedom to achieve the perfect balance of control, confidence and performance!

  • Full wireless range of approximately 3 meters (10 feet) via secure Bluetooth®** connection
  • Eliminates clutter and the need for cables in the operating room
  • Offers traditional and dual-linear functionality
  • Non-zero start capabilities to increase efficiency
  • Quick and easy touchscreen set-up
**Bluetooth is a trademark of Bluetooth SIG, Inc

Easy-to-use, advanced technology

Intuitive touch screen

With the WHITESTAR Signature® system's ergonomic accessories and streamlined interface, the efficiency of the surgical environment is improved. It offers a number of new time-saving features including fast prime/tune, one-step easy-load tubing pack, intuitive user interface, and a sophisticated on-screen help program. It also incorporates today's high technology into cutting-edge features and accessories.

  • One-touch prime/tune cycle is AMO's fastest ever to expedite OR turnover
  • Surgeon settings can be uploaded to any WHITESTAR Signature® System from a memory stick
  • Wireless Bluetooth®** accessories and multi-lingual voice confirmation for hands-free communication and control
  • 17" LCD panel touch screen features one-touch access to all settings
  • Easy-to-use wireless remote gives OR staff more flexibility

**Bluetooth is a trademark of Bluetooth SIG, Inc

Revolutionary surgical archive and teaching tool

Designed for use with AMO's latest phaco systems, the Surgical Media Center revolutionizes surgical data management and phaco education with a new and innovative approach to traditional video overlay. This flexible surgical archive and teaching tool offers a real-time blending of system data and surgical video, as well as comprehensive playback and editing capability. No other overlay system can match its level of sophistication, adaptability, and ease.

  • Offers a unique presentation / surgical archive and teaching tool
    • Unique recall capability allows you to go back and view data and events even if they were not displayed during surgery
    • Manipulate data previews in a variety of ways (e.g. enlarge a graph or move the data to a different area of the screen so it doesn't block the surgical footage)
    • Make advanced video presentations and play back recordings using enhanced features including frame-by-frame analysis
  • Provides customizable video overlays
    • Choose data parameters such as aspiration, vacuum, power, bottle height, and occlusion settings from 20 different selections and combinations
    • Configure the screen as data plots, animated images, plain text, or static images

Tubing pack

The FUSION® Fluidics tubing pack offers one-step, auto-loading capabilities for instantaneous, accurate vacuum response.

FUSION® Fluidics Single-Use Tubing OPO70

The Tubing Pack includes:

  • Mayo drape
  • Screen drape
  • Tubing manifold and irrigation/aspiration tubing
  • Integrated, closed drain bag

ELLIPS® FX Technology

ELLIPS® FX Technology is uniquely designed to deliver smooth cutting and excellent efficiency - all without having to change your preferred technique.

  • Superb, leading-edge performance and efficient lens extraction4
  • Simultaneous blending of transversal and longitudinal modalities
  • Enhanced followability and effectively holds fragments at the tip end
  • Smooth, efficient cutting for hard and soft lenses4
  • Exceptional versatility with curved or straight tip styles to match your preferred technique
Elliptical cutting pattern enhances
lens emulsification
ELLIPS® FX Handpiece

Peristaltic and Venturi on-the-fly

FUSION® Fluidics OPO71 Dual-Pump Pack
Single cassette with dual pump capability

The WHITESTAR Signature® System features the ability to switch between a true peristaltic pump and true venturi pump on-the-fly. During a procedure, the surgeon can switch instantly into venturi mode for additional vacuum and holding power.6 This capability can be extremely useful in multi-surgeon environments and teaching institutions, allowing the flexibility to use both modalities in one system.

  • On-the-fly switching between flow-based peristaltic and vacuum-based venturi pumps all-in-one cassette
  • Safety of system at high vacuum is maintained
  • Pump choice can be preprogrammed by mode or submode
  • Aspiration capabilities
    • Peristaltic flow up to 60 cc/min
    • Peristaltic maximum vacuum of 650 mm Hg
    • Venturi vacuum up to 600 mm Hg

References

  1. Antao S, Kasaby S. Comparison of ultrasound power used during phacoemulsification with and without improved control and efficiency (ICE) software.
    Paper presented at: European Society for Cataract and Refractive Surgery (ESCRS) 24th Congress; September 9-13, 2006; London, England. Available at:
    http://www.escrs.org.
  2. Fabian E, Maier M, Parasta A. New phaco fluidics control: CASE to prevent surge. Paper presented at: European Society for Cataract and Refractive Surgery (ESCRS) 24th Congress;
    September 9-13, 2006; London, England. Available at: http://www.escrs.org.
  3. Nixon D. Inter-surgeon reproducibility and transferability of settings for the Sovereign® system with WHITESTAR® ICE. Paper presented at: European Society for Cataract and Refractive Surgery
    (ESCRS) 24th Congress; September 9-13, 2006; London, England. Available at: http://www.escrs.org.
  4. Data on file 108. Performance of ELLIPS vs ELLIPS FX. Santa Ana, CA; Abbott Medical Optics Inc.
  5. Dewey S. WHITESTAR® ICE: Igniting 'cool phaco' to improve surgical efficiency. Paper presented at: European Society for Cataract and Refractive Surgery (ESCRS) 24th Congress; September
    9-13, 2006; London, England. Available at: http://www.escrs.org.
  6. Bethke W. The Cutting Edge of Cataract Surgery. Rev Ophthalmol. 2007; April:76-80.

Additional information for Health Care Professionals

To obtain additional information about the WHITESTAR Signature® System, please visit:


www.whitestarsignature.com


Important Safety Information

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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.



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