WHITESTAR SIGNATURE PRO Operators Manual Addendum Rev C March 2016

WHITESTAR SIGNATURE PRO System

ADDENDUM WARNING: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the WHITESTAR SIGNATURE PRO System or shielding the location. WARNING: WHITESTAR SIGNATURE PRO System may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.

Additional information for Wireless Setup - Foot Pedal and Remote Control in the WHITESTAR SIGNATURE PRO System Manual NGPZ370500 Chapter 6. Note:

If you have problems pairing the Advanced Control Pedal (ACP) and the remote control, remove any other BLUETOOTH devices from the area. Multiple BLUETOOTH devices can affect the pairing process.

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WHITESTAR SIGNATURE PRO System

Errors

ADDENDUM

The following error information is in addition to the specifications in the WHITESTAR SIGNATURE PRO Operators Manual NGPZ370500 Chapter 8. During the operation of the WHITESTAR SIGNATURE PRO System, various errors may be displayed to indicate a fault that can affect the system. When errors are detected, the following occurs: • A tone is generated. • A message is displayed indicating the error. • The system goes into a safe state without user intervention: • Phaco, I/A, Vitrectomy, and Diathermy functions are disabled. • Irrigation valve is automatically opened to the balanced salt solution and the aspiration path is vented ensuring that there is no residual vacuum and chamber pressure is maintained in the eye during the error state. • In this state, all the surgical modes become inoperative. To resolve the errors, refer to Chapter 8 Error Messages Troubleshooting and Diagnostics and follow the described corrective actions.

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WHITESTAR SIGNATURE PRO System

Electromagnetic Information

ADDENDUM

The Electromagnetic Information is in addition to the specifications in the WHITESTAR SIGNATURE PRO Operators Manual NGPZ370500 Chapter 10.

Table 1 – Electromagnetic Emissions Guidance and manufacturer's declaration - electromagnetic emissions The WHITESTAR SIGNATURE PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the WHITESTAR SIGNATURE PRO System should assure that it is used in such an environment.

Emissions Test

Compliance

RF emissions  CISPR 11

Group 1

RF emissions  CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage Fluctuations/ Flicker emissions

Complies

The WHITESTAR SIGNATURE PRO System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The WHITESTAR SIGNATURE PRO System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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WHITESTAR SIGNATURE PRO System

ADDENDUM

Table 2 – Electromagnetic Immunity Guidance and manufacturer's declaration - electromagnetic immunity The WHITESTAR SIGNATURE PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the WHITESTAR SIGNATURE PRO System should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD)  IEC 61000-4-2

±6 kV contact ±8 kV air

±2 kV contact ±8 kV air (*)

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst  IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

ElectroSurge  IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode  ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines  IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the WHITESTAR SIGNATURE PRO System requires continued operation during power mains interruptions, it is recommended that the WHITESTAR SIGNATURE PRO System be powered from an uninterruptible power supply or a battery.

(50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note:

UT is the a.c. mains voltage prior to application of the test level.

(*) When ±2 kV, ±4 kV & 6 kV contact discharge were applied to all metal parts of the ACP & ALP Foot Pedal, performance interruption occurred. ACP Foot Pedal loses communication to the system. It requires user intervention to recover all its function without losing stored data. Per client declaration it is an acceptable performance criteria. Below is client justification for the observed EUT performance.  Foot pedals (wireless & wired mode): If the wireless connection is lost during surgery, the console will be placed into a safe state, causing the surgical procedure to halt. Upon reconnection of the foot pedal cable, the error is removed and the procedure can recommence.

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WHITESTAR SIGNATURE PRO System

ADDENDUM

Table 3 – Electromagnetic Immunity Guidance and manufacturer's declaration - electromagnetic immunity The WHITESTAR SIGNATURE PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the WHITESTAR SIGNATURE PRO System should assure that it is used in such an environment Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the WHITESTAR SIGNATURE PRO System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  Conducted RF IEC 61000-4-6

  3 Vrms 150 kHz to 80 MHz

  3 Vrms

Recommended separation distance: d = 1.2P d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.5 GHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note:

At 80 MHz and 800 MHz, the higher frequency range applies.

Note:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the WHITESTAR SIGNATURE PRO System is used exceeds the applicable RF compliance level above, the WHITESTAR SIGNATURE PRO System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the WHITESTAR SIGNATURE PRO System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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WHITESTAR SIGNATURE PRO System

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Table 4 – Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the WHITESTAR SIGNATURE PRO System The WHITESTAR SIGNATURE PRO System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the WHITESTAR SIGNATURE PRO System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WHITESTAR SIGNATURE PRO System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2P

80 MHz to 800 MHz d = 1.2P

800 MHz to 2.5 GHz d = 2.3P

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.2

1.2

2.3

10

3.7

5.7

7.4

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

System Cables Table 5 – System Cables Manufacturer

Manufacturer Part Number

Description

Maximum Length

AMO

2410-0049-L

Power cord, hospital grade, 20 ft., 6.1 meters

6.1 meter

AMO

0100-0055

Cable Assy, WHITESTAR Series Foot Pedal

3.7 meter

AMO

0100-6303

Cable Assy, Advanced Linear Foot Pedal to Console, Signature

3.7 meter

AMO

690697

WHITESTAR Phaco Handpiece, Coaxial

2.2 meter

AMO

690880

ELLIPS FX Phaco Handpiece

2.2 meter

AMO

SCP680600

Diathermy Cord

3.6 meter

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WHITESTAR SIGNATURE PRO System

ADDENDUM

RF Wireless Technology Table 6 – RF Wireless Technology Used on the WHITESTAR SIGNATURE PRO System Devices

RF Wireless Technology

Part Number

Operating Frequencies

Operating Distances

Industry Standard

NGP680703 WHITESTAR SIGNATURE PRO Advanced Linear Pedal (ALP)*

BLUETOOTH Low Energy (two individual chips)

Texas Instruments CC2541F256RHAT

2.402 to 2.480 GHz, Adaptive Frequency Hopping GFSK (Gaussian FrequencyShift Keying) over 37 Channels 2 MHz apart, 3 advertising Channels

Class 2 - 3 meters

BLUETOOTH Specification version 4.0 FCC CFR47, Part 15, sections 15.205, 15.209, 15.247 and 15.249

Device System Wireless Functions, Capabilities, and Limitations ALP Wireless Technology: Wirelessly and uniquely connects the ALP to the console to facilitate full functional control of the WHITESTAR SIGNATURE PRO System the same as if connected by cord. Function is limited to a 3 meter range. The ALP is a BLUETOOTH 4.0 (BLUETOOTH Low Energy) device that utilizes two TI CC2541 chips that communicates with the console through a transceiver that also utilizes two CC2541 chips. Functional ability: Consists of four programmable switches and a treadle that allows the operator to activate different functionalities at its corresponding pitch zone. Limitations during device operation: The device must be used within the specified operating range.

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WHITESTAR SIGNATURE PRO System

ADDENDUM

Devices

RF Wireless Technology

Part Number

Operating Frequencies

Operating Distances

Industry Standard

NGP680701 WHITESTAR SIGNATURE ACP*

BLUETOOTH 2.0 (three individual chips, two for foot pedal, one for remote)

Texas Instruments LMX9830SM/ NOPB

2.402 to 2.480 GHz, Adaptive Frequency Hopping over 79 Channels, 1 MHz Apart

Class 2 - 3 meters

BLUETOOTH Specification version 2.0 + EDR

and  NGP680137 WHITESTAR SIGNATURE PRO Remote Control*

FCC CFR47, Part 15, Sections 15.205, 15.209, 15.247 and 15.249

Device System Wireless Functions, Capabilities, and Limitations ACP Wireless Technology: Wirelessly and uniquely connects the ACP to the console to facilitate full functional control of the WHITESTAR SIGNATURE PRO System the same as if connected by cord. Function is limited to a 3 meter range. The ACP is a BLUETOOTH 2.0 device that utilizes two TI LMX9838 BLUETOOTH modules, which communicate with the console through a wireless transceiver that utilizes two TI LMX9830 BLUETOOTH modules. Functional ability: The ACP consists of several linear controls and digital switches to activate different functionalities at its corresponding pitch zone. Limitations during device operation: The device must be used within the specified operating range. Remote Control Wireless Technology: Wirelessly and uniquely connects the Remote Control to the console to navigate the GUI display. Function is limited to a 3 meter range.

RX Only – NGP Z370530 Rev. C 0316

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WHITESTAR SIGNATURE PRO System Devices

RF Wireless Technology

ADDENDUM

Part Number

Operating Frequencies

Operating Distances

Industry Standard

Device System Wireless Functions, Capabilities, and Limitations The remote control is powered with an internal rechargeable NiMH battery, and has a BLUETOOTH 2.0 device that utilizes a TI LMX9830 BLUETOOTH module for its RF communication. It communicates with the system via a BLUETOOTH dongle residing in the system, which also utilizes a LMX9830 BLUETOOTH module. The remote control is an accessory that provides an alternative method for the operator to navigate through the different surgical modes, set various parameters, and perform IV pole height adjustment. Functional ability: The Remote Control consists of 12 buttons with their functionality described below: • IV Pole Up/Down: IV pole height adjustment. • Mode: for operator to select preprogrammed surgeon mode. • Navigator Up, Down, Left, Right, and Enter: navigate to access different functional icons on the screen within the surgical mode. • Up, Down, Enter: for operator to navigate to desired surgical mode. • Back-light: for operator to turn on Remote control backlight. Limitations during device operation: The device must be used within the specified operating range.

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WHITESTAR SIGNATURE PRO System

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Devices

RF Wireless Technology

Part Number

Operating Frequencies

Operating Distances

Industry Standard

NGP680301 WHITESTAR SIGNATURE PRO Console*

Wireless PCIeM Card 802.11b/ g/n

Advantech EWMW142H01E

2.4 to 2.483 GHz, DSSS and OFDM modulation over 16 Channels 5MHz apart

Up to 3 meters

IEEE 802.11N-2009

Device System Wireless Functions, Capabilities, and Limitations Console Wireless Technology: The WHITESTAR SIGNATURE PRO Phacoemulsification System console downloads surgery case data via Wi-Fi to iPad for formatting/ printing/ presentation. The system has a Wi-Fi adapter that allows the surgical data to be downloaded to an iPad with our proprietary application, using IEEE 802.11 b/g/n standard Functional ability: it provides the operator with an ability to download data from the system to an iPad. Please note that the console does not store any patient information. The iPad connection to the system is password-protected and data flow is unidirectional from the console to the iPad. Limitations during device operation: The device must be used within the specified operating range.

* All devices are on the 2.4 GHz ISM band.

RX Only – NGP Z370530 Rev. C 0316

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WHITESTAR SIGNATURE PRO System

ADDENDUM

Table 7 – Wireless Technologies Used for Each of the Wireless Devices Devices NGP680703  WHITESTAR SIGNATURE PRO Advanced Linear Pedal (ALP)*

RF Wireless Technology BLUETOOTH Low Energy (two individual chips)

Operating Distances Class 2 - 3 meters

Quality of Service and Security In addition to the inherent data integrity by using the BLUETOOTH technology, the system design also incorporated redundant BLUETOOTH channels (2 channels) to further improve the quality of service for this wireless device, and reduce the chance of losing wireless connection between the foot pedal and the console. The wireless communication is secured by BLUETOOTH encrypted data technology.

Device System Wireless Function, Capabilities, and Limitations ALP Wireless Technology: Wirelessly and uniquely connects the ALP to the console to facilitate full functional control of the WHITESTAR SIGNATURE PRO System the same as if connected by cord. Function is limited to a 3 meter range. The ALP is a BLUETOOTH 4.0 (BLUETOOTH Low Energy) device that utilizes two TI CC2541 chips that communicates with the console through a transceiver that also utilizes two CC2541 chips. Functional ability: Consists of four programmable switches and a treadle that allows the operator to activate different functionalities at its corresponding pitch zone. Limitations during device operation: The device must be used within the specified operating range. .

NGP680701  WHITESTAR SIGNATURE Advanced Control Pedal (ACP)*

BLUETOOTH 2.0 (two individual chips)

Class 2 - 3 meters

In addition to the inherent data integrity by using the BLUETOOTH technology, the system design also incorporated redundant BLUETOOTH channels (2 channels) to further improve the quality of service for this wireless device, and reduce the chance of losing wireless connection between the foot pedal and the console. The wireless communication is secured by BLUETOOTH encrypted data technology.

ACP Wireless Technology: Wirelessly and uniquely connects the ACP to the console to facilitate full functional control of the WHITESTAR SIGNATURE PRO System the same as if connected by cord. Function is limited to a 3 meter range. The ACP is a BLUETOOTH 2.0 device that utilizes two TI LMX9838 BLUETOOTH modules, which communicate with the console through a wireless transceiver that utilizes two TI LMX9830 BLUETOOTH modules. Functional ability: The ACP consists of several linear control and digital switches to activate different functionalities at its corresponding pitch zone. Limitations during device operation: The device must be used within the specified operating range.

RX Only – NGP Z370530 Rev. C 0316

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WHITESTAR SIGNATURE PRO System Devices NGP680137 WHITESTAR SIGNATURE PRO Remote Control*

ADDENDUM

RF Wireless Technology BLUETOOTH 2.0 (one chip)

Operating Distances Class 2 - 3 meters

Quality of Service and Security The quality of service is ensured by the BLUETOOTH technology. The WHITESTAR SIGNATURE PRO System uses the touchscreen as the primary user interface device. In the rare event of losing communication between the remote control and the console, the user can continue to operate all system functions by using the touchscreen. The wireless communication is secured by BLUETOOTH encrypted data technology.

Device System Wireless Function, Capabilities, and Limitations Remote Control Wireless Technology: Wirelessly and uniquely connects the Remote Control to the console to navigate the GUI display. Function is limited to a 3 meter range. The remote control is powered with an internal rechargeable NiMH battery, and has a BLUETOOTH 2.0 device that utilizes a TI LMX9830 BLUETOOTH module for its RF communication. It communicates with the system via a BLUETOOTH dongle residing in the system, which also utilizes a LMX9830 BLUETOOTH module. The remote control is an accessory that provides an alternative method for the operator to navigate through the different surgical modes, set various parameters, and perform IV pole height adjustment. Functional ability: The Remote Control consists of 12 buttons with their functionality described below: • IV Pole Up/Down: IV pole height adjustment. • Mode: for operator to select preprogrammed surgeon mode. • Navigator Up, Down, Left, Right, and Enter: navigate to access different functional icons on the screen within the surgical mode. • Up, Down, Enter: for operator to navigate to desired surgical mode. • Back-light: for operator to turn on Remote control back-light. Limitations during device operation: The device must be used within the specified operating range.

RX Only – NGP Z370530 Rev. C 0316

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WHITESTAR SIGNATURE PRO System Devices NGP680301 WHITESTAR SIGNATURE PRO Console*

RF Wireless Technology Wireless  PCIe-M Card 802.11b/g/n

ADDENDUM Operating Distances Up to 3 meters

Quality of Service and Security The quality of service is ensured by the Wi-Fi technology. Downloading data from the WHITESTAR SIGNATURE PRO System to the iPad application does not interfere with system surgical functions. In the rare event of losing communication between the iPad and the console while downloading data, the application will notify the user to retry. The wireless communication is secured by Wi-Fi connection password.

Device System Wireless Function, Capabilities, and Limitations Console Wireless Technology: The WHITESTAR SIGNATURE PRO Phacoemulsification System console downloads surgery case data via Wi-Fi to iPad for formatting/ printing/ presentation. The system has a Wi-Fi adapter that allows the surgical data to be downloaded to an iPad with our proprietary application, using IEEE 802.11 b/g/n standard Functional ability: The Wi-Fi adapter provides the operator with an ability to download data from the system to an iPad. Please note that the console does not store any patient information. The iPad connection to the system is password-protected and data flow is unidirectional from the console to the iPad. Limitations during device operation: The device must be used within the specified operating range.

* All devices are on the 2.4 GHz ISM band.

RX Only – NGP Z370530 Rev. C 0316

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