User's Manual

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Table Of Contents

ADDENDUM

MANUAL SPECIFICATION

DOCUMENT NO: Z370530

REVISION: A

TITLE: WS SIGNATURE PRO OPERATOR’S MANUAL ADDENDUM (ENGLISH), CE MARK

SPECIFICATIONS:

1. BINDER: N/A

2. TEXT:

2.1 DIMENSIONS: 8 1/2“ X 11” THREE RINGS, WHITE LASER PAPER

NOTE: DIMENSIONS ARE FOR REFERENCE DIMENSION ONLY.

2.2 TYPE OF PAPER: 60# OFFSET, WHITE, 3 RING PUNCHED

2.3 INK COLOR: BLACK ON WHITE PAPER. PRINTING TO BE CLEAR AND

LEGIBLE WITH NO INK SMEARS.

NOTE: COLOR VARIATION DUE TO COLOR BANDING INHERENT

IN DIGITAL PRINTING OF SOLID COLORS IS ALLOWABLE

2.4 TYPE OF COPY: SINGLE COPY, PRINT 2 SIDES.

3. COVER & SPINE: N/A

4. TAB PAGES: N/A

5. ASSEMBLY / PACKAGING: Shrink-wrap assembled binder with copy of first page of document

(cover page) between shrink and outside of binder. Manual identify from cover page (version, part

number, etc.) must be facing out and visible for warehouse identification.

6. LANGUAGES: English

7. POINTS OF USE: AMO Santa Ana, CA, AMO Milpitas, CA

CHANGE SUMMARY

REVISION

DESCRIPTION OF CHANGE

Initial release of WHITESTAR SIGNATURE PRO Operator’s Manual Addendum.

Page 1 of 14

SOP501027-T007 Rev.01

Summary of content (14 pages)

PAGE 1
MANUAL SPECIFICATION DOCUMENT NO: Z370530 REVISION: A TITLE: WS SIGNATURE PRO OPERATOR’S MANUAL ADDENDUM (ENGLISH), CE MARK SPECIFICATIONS: 1. BINDER: N/A 2. TEXT: 2.1 DIMENSIONS: 8 1/2“ X 11” THREE RINGS, WHITE LASER PAPER NOTE: DIMENSIONS ARE FOR REFERENCE DIMENSION ONLY. 2.2 TYPE OF PAPER: 60# OFFSET, WHITE, 3 RING PUNCHED 2.3 INK COLOR: BLACK ON WHITE PAPER. PRINTING TO BE CLEAR AND LEGIBLE WITH NO INK SMEARS.
PAGE 2
ADDENDUM The Warning and Symbol definitions are in addition to those same lists in: • WHITESTAR SIGNATURE PRO Operators Manual NGPZ370500 Chapter 1. WARNINGS: 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.
PAGE 3
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.
PAGE 4
WHITESTAR SIGNATURE PRO System ADDENDUM The Electromagnetic Information is in addition to the specifications in: • WHITESTAR SIGNATURE PRO Operators Manual NGPZ370500 Chapter 10. Electromagnetic Information 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.
PAGE 5
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.
PAGE 6
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.
PAGE 7
WHITESTAR SIGNATURE PRO System ADDENDUM Guidance and manufacturer's declaration - electromagnetic immunity 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.
PAGE 8
WHITESTAR SIGNATURE PRO System System Cables Manufacturer ADDENDUM Table 5 – System Cables 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.
PAGE 9
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.
PAGE 10
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.
PAGE 11
WHITESTAR SIGNATURE PRO System ADDENDUM 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.
PAGE 12
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
PAGE 13
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.
PAGE 14
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.RO Downloading data from the WHITESTAR SIGNATURE PRO System to the iPad application does not interfere with system surgical functions.