Addendum for Abbott Medical Optics SOVEREIGN Signature Operators Manual Rev B Sept 2012

WHITESTAR SIGNATURE System

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ADDENDUM

The Warning and Symbol definitions replace those same lists in: • WHITESTAR SIGNATURE Operators Manual Z370252 Chapter 3 • WHITESTAR SIGNATURE Operators Manual Z370338 Chapter 1.

WARNINGS WARNING: All personnel who might operate this equipment must 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. WARNING: The system comes equipped with a 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. WARNING: 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) WARNING: DO NOT attempt to use the system if the system fails to perform properly as stated in this manual.

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• Addendum WARNING: 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 • oxidizing agents WARNING: 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. WARNING: 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. WARNING: Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, mayo stand drape, and monitor drape. WARNING: Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware.

WARNING: Do not modify the pole height or manually force the pole height because this could cause incorrect indication of bottle height and patient injury. WARNING: 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. WARNING: Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient. WARNING: The output power selected must be as low as possible for the intended purpose.

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• Addendum WARNING: 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. WARNING: 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.

WARNING: 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. WARNING: Hazardous electrical output. This equipment is for use only by qualified personnel.

WARNING: 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 you can readily remove the power cord.

WARNING: 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. WARNING: You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT.

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• Addendum WARNING: Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. WARNING: 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. You must sterilize all non-sterile accessories prior to use.

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. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. WARNING: 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.

Symbol Definitions

The following symbols appear on the WHITESTAR SIGNATURE System front and back panels and in the software: Symbol

Definition Symbol on the power switch indicates power is on.

Symbol on the power switch indicates power is off.

Indicates there is a possible danger to the user. In the manual, the symbol indicates information the user must read. Indicates that there are important operating and maintenance instructions included in the operator’s manual. Indicates the presence of uninsulated high voltage inside the instrument. Risk of electric shock. Do not remove the instrument cover.

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• Addendum Definition Indicates fuse. Single phase alternating current. Indicates isolation of the patient applied part from earth ground. Indicates grounding of the patient applied part OR no involvement of direct electrical energy. Foot pedal connection. Communications port

Programmable IV pole Diathermy receptacle Phaco handpiece receptacle Vitrectomy cutter receptacle Potential equalizer used to identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding. IPX8 is the International Protection code that indicates that the device is protected against the effects of continuous immersion in water. Indicates compliance with the Medical Device Directive.

Indicates the authorized European Union representative. Separate disposal/collection required

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WHITESTAR SIGNATURE System Symbol

• Addendum Definition Indicates manufacturer of the WHITESTAR SIGNATURE System. Environment friendly use period in years (RoHS)

Indicates compliance with IEC 60601-1-2:2001, “Electromagnetic Compatibility Requirements and Tests for Medical Electrical Equipment.” ETL Listed Mark issued to those products that have met the requirements of product safety standards for the United States and Canada. (ETL formerly Edison Testing Laboratory) Universal Serial Bus (USB) port Note: Use only AMO recommended USB stick drives. Federal Communications Commission (FCC) The FCC regulates interstate and international communications by radio, television, wire, satellite, and cable under the FCC’s jurisdiction. Mark on shipping crate indicating not to open the crate except by authorized personnel.

FUSION mode button used to open the CASE and the Occlusion mode settings screen. Standard foot pedal icon. Shows the current position of the foot pedal as you press the foot pedal. The number changes when the position of the foot pedal changes. When pressed, the Foot Pedal Configuration screen opens. Advanced Control Pedal icon. Shows the current position of the foot pedal as you press the foot pedal. The number changes when the position of the foot pedal changes. The letters indicate the location of Aspiration (A), Irrigation (I), Phaco (P), Reflux (R), WHITESTAR increment/ decrement (WS) and Switch (S). When pressed, the Foot Pedal Configuration screen opens WHITESTAR technology is on.

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Symbol

Definition WHITESTAR technology is on and ICE pulse shaping is on. ELLIPS technology is on. ELLIPS FX handpiece is activated. The reload button cycles through the surgeon’s programs. Continuous irrigation. Used to turn continuous irrigation on or off. Volume control, when pressed cycles through the volume settings. Used to save changes made to settings during surgery.

Specifications

These tables replace: • WHITESTAR SIGNATURE Operators Manual Z370252 Chapter 12 Table 12.2, 12.3 and Table 12.6 • WHITESTAR SIGNATURE Operators Manual Z370338 Chapter 11 Table 11.2, Table 11.3 and Table 11.6.

Environmental Specifications Environmental Specifications

Storage/Transportation Conditions

Operating Temperature

10 to 40°C

Humidity

Up to 95% RH, non-condensing

Ambient Pressure

See Vitrectomy Specifications for additional information.

Storage Temperature

-20 to 60°C

Humidity

Up to 95% RH, non-condensing

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Electrical Specifications

System

Voltage

Frequency

Rated Power

Fuse Rating

Enclosure Current Leakage

100-240 Vac

50-60 Hz

750 VA

6.3A, 250V, Bussman GDA

<500 μA

Vitrectomy Specifications

Diathermy Specifications

Peristaltic Pump

Vacuum Level

0–650 mmHg in 5 mmHg increments

Pump Flow Rate

10 to 60 cc/minute, in 2 cc increments

Venturi Pump

Vacuum Level

0-600 mmHg in 5 mmHg increments

Atmospheric Pressure/Altitude

Density Altitude (DA) conditions are 2,500 cpm from sea level to 3,000 feet (914.4 m) elevation and shall be de-rated by 100cpm per 1,000ft (304.8 m) additional elevation up to a maximum of 697 millibars.

Indicated Cut Rate

Actual Cut Rate Upper Limit (cpm)

Actual Cut Rate Lower Limit (cpm)

2500

3000

2000

Table Addendum.1 – Diathermy Specifications Power Adjustment

5 to 100%, in 5% increments

Diathermy Power (maximum power into rated load)

8.5 Watts into 350 Ohms 386 kHz

Diathermy Type

Bipolar

Rated Peak Voltage (No Load)

160 Volts

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Connector of diathermy forcep/ probe

Ø.072 RECEPTACLE (2)

All measurements are in inches.

Diathermy Power Graphs

The charts below are based on Rated Peak Voltage (No Load):160 Volts. These figures replace: • WHITESTAR SIGNATURE Operators Manual Z370252 Chapter 12 Figures 12.1 through 12.8 • WHITESTAR SIGNATURE Operators Manual Z370338 Chapter 11 Figures 11.1 through 11.8.

Figure Addendum.1 – Diathermy Output Power (Typical) 10 Ohm

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Figure Addendum.2 – Diathermy Output Power (Typical) 50 Ohm

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Figure Addendum.3 – Diathermy Output Power (Typical) 200 Ohm

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Figure Addendum.4 – Diathermy Output Power (Typical) 350 Ohm

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Figure Addendum.5 – Diathermy Output Power (Typical) 500 Ohm

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Figure Addendum.6 – Diathermy Output Power (Typical) 1000 Ohm

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Diathermy Power versus Load Impedance Figure Addendum.8 – Diathermy Output Power (50% Setting)

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Figure Addendum.9 – Diathermy Output Power (100% Setting)

Phaco Tip Velocity

The following table is new to the Phaco Power Graph section in: • Chapter 12 for WHITESTAR SIGNATURE Operators Manual Z370252 • Chapter 11 for WHITESTAR SIGNATURE Operators Manual Z370338 Nominal Velocity for the ELLIPS FX handpiece and the WHITESTAR handpiece at 100% power, continuous, with the OPOR3020L phaco tip is shown in the following table. Handpiece

Nominal Longitudinal Velocity (m/s)

ELLIPS FX (690880 (A))

8.85

WHITESTAR (690697 (A))

11.13

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Bottle Height Pressure

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Bottle Height Pressure is a new heading within: • Chapter 12 for WHITESTAR SIGNATURE Operators Manual Z370252 • Chapter 11 for WHITESTAR SIGNATURE Operators Manual Z370338 The WHITESTAR SIGNATURE System has a built in IV pole to generate positive pressure using balanced salt solution to provide positive irrigation fluid. Measurement points: • All measurements are taken with a pressure meter at the same height as the pressure sensor in the WHITESTAR SIGNATURE System. • This position is defined as 41 inches or 101.6 cm from the floor.

1. Center of Drip Chamber 2. Center of pressure sensor is 41 inches or 104.2 cm from the floor

An IV bottle height reported as 0 cm includes an offset of 7.9 inches or 20 cm to make sure that a positive pressure is always provided. Expected Pressure as a function of Bottle Height Bottle Height cm Theoretical Pressure mmHg

Corrected Pressure vs IV Pole Height mmHg

0

0.00

14.80

20

14.80

29.60

40

29.60

44.40

60

44.40

59.20

80

59.20

74.00

100

74.00

88.80

105

77.70

92.50

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