3 SYSTEM SETUP Safety Precautions Warnings Symbol Definitions System Disposal Setup Sequence – Anterior Segment Surgery Footpedal Programmable IV Pole Wireless Remote Control Surgical Media Center (SMC) (Optional) Shutdown Sequence – Anterior Segment Surgery Rx Only – NGP Z370165 Rev.
WHITESTAR SIGNATURE System Safety Precautions 3 • System Setup Now that you have set the system up and you have verified that all the functions are operating properly, you are almost ready to use your WHITESTAR SIGNATURE System. Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR SIGNATURE System in surgery. 1. The WHITESTAR SIGNATURE System comes equipped with 3-prong power plug which you must plug into an outlet with a ground receptacle.
WHITESTAR SIGNATURE System 3 • System Setup 15. Always replace the tubing pack between cases. 16. Wrap the excess power cord neatly around the cord wrap on the back of the console. Changing Irrigation Flow Use extreme caution when you lower or raise the balanced salt solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse. If you raise the bottle too high it can cause the anterior chamber to deepen.
WHITESTAR SIGNATURE System 3 • System Setup Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 9, “Care and Cleaning”. Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling. Phaco and Vitrectomy Operation Do not activate the phaco handpiece and the vitrectomy cutter with the tips exposed to air. Do not activate the tips in the air, as this reduces the useful life of the handpiece and the cutter.
WHITESTAR SIGNATURE System 3 • System Setup Wireless Remote Control This device complies with Ppart 15.19 of the FCC (Federal Communications Commission) Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. ! Any changes or modifications not expressly approved by AMO can void the user's authority to operate the equipment. (FCC Part 15.
WHITESTAR SIGNATURE System ! ! 3 • System Setup WARNING: DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. 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.
WHITESTAR SIGNATURE System ! ! 3 • System Setup 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.
WHITESTAR SIGNATURE System ! ! ! ! ! ! Symbol Definitions 3 • System Setup WARNING: You do not need to use a NEUTRAL ELETRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. 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.
WHITESTAR SIGNATURE System Symbol ! 3 • System Setup Definition 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. Indicates fuse.
WHITESTAR SIGNATURE System Symbol 3 • System Setup Definition Phaco Handpiece Receptacle Vitrectomy Cutter Connection Potential Equalizer Indicates compliance with the Medical Device Directive. Indicates the authorized European Union representative. Separate Disposal/Collection Required Indicates manufacturer of the WHITESTAR SIGNATURE System.
WHITESTAR SIGNATURE System Symbol 3 • System Setup Definition Federal Communications Commission (FCC) The FCC regulates interstate and international communications by radio, television, wire, satellite, and cable under the FCC’s jurisdiction. FUSION Mode button used to open the CASE settings screen. Single Linear Foot Pedal Icon. Shows the position of the footpedal when you press the footpedal. The number changes when the position of the footpedal changes. Advanced Control Pedal (Dual Linear) Icon.
WHITESTAR SIGNATURE System System Disposal 3 • System Setup WEEE The electronic components of the WHITESTAR SIGNATURE System are subject to the European Union Directive 2002/96/EC on Waste Electrical and Electronic Equipment. This directive applies to all electronic equipment in the European Union only. The disposal to municipal waste is prohibited for electronic equipment subject to this directive; this equipment must be treated or recycled.
WHITESTAR SIGNATURE System 3 • System Setup Germany Ireland AMO Germany GmbH Rudolf-Plank Strasse 31 D-76275 Ettlingen Germany Phone: +49 7243 729 444 (Hotline) AMO Ireland Block B Liffey Valley Office Campus Quarryvale, Co. Dublin, Ireland Italy Netherlands AMO Italy Srl Via Pio Emmanuelli, n.1 00143 Rome Italy Phone: +39 06 51 29 61 AMO Netherlands B.V.
WHITESTAR SIGNATURE System 3 • System Setup Switzerland United Kingdom Distributor AMO Switzerland GmbH, Churerstrasse 160 B, CH-8808 Pfäffikon, Switzerland AMO United Kingdom Ltd Jupiter House Mercury Park Wooburn Green High Wycombe Buckinghamshire HP10 0HH United Kingdom Phone: +44 1628 551600 RoHS (Restriction of Hazardous Substances) For Chinese Regulation: Administrative Measure on the Control of Pollution Caused by Electronic Information Products.
WHITESTAR SIGNATURE System Setup Sequence – Anterior Segment Surgery 3 • System Setup The following is a general overview of the steps to take to prepare the WHITESTAR SIGNATURE System for surgery: 1. Connect the WHITESTAR SIGNATURE System power cord to the rear of system. Plug the power cord into a grounded power outlet. 2. Connect the footpedal to the rear panel receptacle. 3. Connect the compressed air line to the compressed air receptacle (optional). 4. Turn the system On at the back of the console.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.1 – Rear Panel Connections 1 2 3 4 5 6 1. USB Port 2. Communications Port 3. Foot Pedal Connector 4. Compressed Air 5. Potential Equalizer 6. Power Switch and Power Cord Connection Phacoemulsification Ultrasonic Handpiece ! ! WARNING: Sterility assurance is the responsibility of the user. You must sterilize all nonsterile accessories prior to use.
WHITESTAR SIGNATURE System 3 • System Setup 3. Assemble the phaco handpiece as shown below. You need the handpiece, titanium phaco tip, the appropriate tip wrench, one of the infusion sleeves and the test chamber. CAUTION: NEVER ATTEMPT TO STRAIGHTEN A BENT NEEDLE. THIS MIGHT PRODUCE A BROKEN TIP WHEN YOU APPLY ULTRASOUND. ! Figure 3.2 – Phaco Handpiece Assembly 1 2 3 1. Test Chamber 2. Infusion Sleeve 3. Handpiece with Tip 4.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.4 – IA Handpiece Assembly 1 2 3 4 1. Infusion Sleeve 2. SOLO Straight Tip 3. Handpiece 5 4. SOLO Curved Tip 5. SOLO 45o Silicone Sleeve Tip 2. Load the FUSION Tubing Pack 3. Open the tubing pack packaging. 4. Install the FUSION pack into the side receptacle, as shown below. 5. Make sure that the pack has a properly attached drainage bag. Figure 3.5 – Loading the FUSION Tubing Pack Note: Press the button above the pack to remove the pack.
WHITESTAR SIGNATURE System 3 • System Setup Setup Completion IMPORTANT: Before you insert the spike into the bottle, shake the irrigation drip chamber at the end of the irrigation tubing to confirm that the irrigation valve moves. If the valve does not rattle, the valve cannot operate properly and irrigation cannot flow. 1. Place a new bottle of balanced salt solution on the top of the system console. 2. Insert the drip chamber spike into the balanced salt solution bottle. 3.
WHITESTAR SIGNATURE System 3 • System Setup 8. Attach the female luer fitting end of the aspiration tubing to the phaco handpiece. Note: To protect the patient from contamination, use only: • sterile tubing sets • sterile irrigation fluid • sterile handpieces Figure 3.7 – Phaco Handpiece Connections Diathermy 1. Connect the diathermy cord to the Diathermy Forceps or Pencil Probe. 2. Connect the diathermy cord to the diathermy receptacle on the front panel. Figure 3.8 – Diathermy Forceps Figure 3.
WHITESTAR SIGNATURE System 3 • System Setup 2. Use the instructions provided with the vitrectomy cutter to assemble the handpiece. Figure 3.10 – Vitrectomy Cutter 3. Attach the connector end of the vitrectomy cord to the vitrectomy receptacle on the front panel. Pre-Operative Sterilization Prior to each surgical case, sterilize the WHITESTAR SIGNATURE System instruments identified in Chapter 9, “Care and Cleaning” Instrument Sterilization Procedures.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.11 – Footpedal - Single Linear Figure 3.12 – Footpedal - Advanced Control Pedal (Dual Linear) Footpedal Operation The footpedal has three active “PITCH” ranges, which are referred to as Positions 1, 2 and 3. Position 0 is the Off position, and Position 3 is the fully pressed position. The ranges are shown below. The Advanced Control Pedal has two Yaw switches. Rx Only – NGP Z370165 Rev.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.13 – Footpedal “Pitch” and “Yaw” Positions 1. Pitch Toe Down/Up Configurable Ranges 2. Yaw Toe Right/Left Configurable Ranges The footpedal position determines the function that is delivered by the handpiece, which depends on the mode selected on the touch screen. When the footpedal has been connected, place your foot on the pedal and press to the desired position.
WHITESTAR SIGNATURE System Programmable IV Pole 3 • System Setup The Programmable IV Pole is controlled by the Up and Down arrows on the upper right of the touch screen, next to the bottle height indicator. The buttons on the remote control and the switch on the side of the console can also be used to control the IV Pole. These controls are used to raise and lower the pole, and the height is indicated in the Programmable IV Pole screen.
WHITESTAR SIGNATURE System Wireless Remote Control 3 • System Setup The wireless remote control keypad can be used to operate the WHITESTAR SIGNATURE System. All Modes, Programs, Diagnostics and End Case can be accessed and adjustments to the settings can be made with the remote control. The buttons on the remote keypad work the same as the controls on the WHITESTAR SIGNATURE System touch screen. Figure 3.14 – Wireless Remote Control Module 1. Remote Backlight On 6. Mode Select 2. Reload 7.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.15 – Wireless Remote Control Module Storage Surgical Media Center (SMC) (Optional) The Surgical Media Center (SMC) is used to record the surgery and the instrument settings to be viewed at a later date and time. The surgery is displayed on a monitor with the instrument settings. The SMC hardware is connected to your WHITESTAR SIGNATURE System Communications port on the rear panel. (See Figure 3.1 Rear Panel Connections.
WHITESTAR SIGNATURE System 3 • System Setup Figure 3.16 – Surgical Media Center Pop-up Window 2. Use the Up and Down arrows to adjust the settings. Translucency is used to make the overlay (instrument settings) more or less opaque. Note: Press on the number in the control panel to open a numeric keypad and enter the required value. Press Enter on the Keypad pop-up window when you are finished. Figure 3.17 – Numeric Keypad Pop-up Window 3. Select the Recording Mode. Off, On, or Automatic.
WHITESTAR SIGNATURE System Shutdown Sequence – Anterior Segment Surgery 3 • System Setup The following is a general overview of the steps to be taken to shut the System down after surgery: 1. Select End Case. 2. Select Shutdown. At the prompt, select Yes. 3. Wait for shutdown sequence to complete. 4. Turn the system Off at the back of the console. 5. Remove the power cord from the power outlet. 6. Wrap the excess power cord neatly around the cord wrap on the back of the console. 7.
