Intuitive Surgical CHB01 RFID TRANSCEIVER 3D-HD CAMERA HEAD User Manual da Vinci Si
Intuitive Surgical, Inc. RFID TRANSCEIVER 3D-HD CAMERA HEAD da Vinci Si
Contents
- 1. User Manual Part 1
- 2. User Manual Part 2
- 3. User Manual Part 3
- 4. User Manual Part 4
User Manual Part 3
Appendix A: Error Handling After Disabling an Instrument Arm After you disable an instrument arm, you still can use the arm clutch and port clutch buttons to move the arm out of the way. In the event of an error specific to the ICB, the system presents the option to disable the ICB on the touchscreen and touchpad. Once the ICB has been disabled, it can not be re-enabled until the next power cycle. Intuitive Surgical designed this feature to allow a user to complete a procedure without use of the EndoWrist instruments that employ the ICB, such as the Vessel Sealer. Non-Recoverable Faults If a fault is non-recoverable, the system must be restarted. The following message is displayed: Non-recoverable fault: XXXX Restart System to continue. Restarting the System During a Procedure If a non-recoverable fault occurs during a procedure, you must completely remove all instruments from the system. The endoscope does not need to be removed. Follow these steps to restart the system: 1. Completely remove all instruments from the system. The endoscope does not need to be removed. If an instrument is grasping tissue, follow the grip release instructions in Chapter 9, Grip Release, on page 9-13. WARNING: If it is not clinically possible to remove an instrument, closely monitor the instrument arm during restart to ensure that no motion occurs. 2. Power off the system: Press the Power button on any system component. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Disabling the Instrument Control Box (ICB) The system takes several seconds to shut down. When complete, all system Power buttons will be lit amber, indicating standby mode, and readiness for restart. 3. Restart the system: Press the Power button on any system component. 4. After the system has restarted successfully, then the instruments can be reinserted. Note: During system restart, video is temporarily unavailable at the Surgeon Console viewer and touchscreen monitor. Note: If the fault cannot be cleared by a system restart, call Intuitive Surgical Technical Support. Emergency Stop Press the red Emergency Stop button should it be necessary to stop system operation at any time. The Emergency Stop button will cease robotic control of the instruments and endoscope. The instruments and endoscope will stay in their last commanded position. If the instrument grips are closed when the Emergency Stop button is pressed, the grips will remain closed. However, the gripping force of the instrument may decrease. Pressing Emergency Stop initiates a recoverable fault, which you can override by pressing Recover on the touchscreen or touchpad. The Emergency Stop button illuminates when pressed and remains illuminated until the fault is recovered. da Vinci® Si™ A-3 A-4 Appendix A: Error Handling Figure A.3 EPO button on rear of Patient Cart The Emergency Power Off (EPO) button is on the back of the Patient Cart. Press this button to completely remove power to the Patient Cart. The system classifies this a non-recoverable fault. The system must be restarted. Battery Backup 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL EPO (Emergency Power Off) Should the Patient Cart be unplugged, the system will generate a recoverable fault that must be addressed to continue a procedure. System operation will be allowed to continue on reserve power, but with basic functionality only. Note: Battery backup is only intended for safe removal of the system components from the patient and is not intended for continuing the procedure. Battery Low Condition If there is insufficient battery backup power on the Patient Cart, cart drive is disabled and the user will have to wait for the battery backup to charge. • To move the cart manually, move the shift switches on the base of the cart to the neutral position. When finished moving the cart, be sure to move the shift switches back to the drive position. Note: The backup battery is not user-serviceable, and must be replaced by authorized personnel only. Contact Intuitive Surgical Technical Support for details. Note: The Patient Cart battery should be adequately charged. If not, an error message appears on the monitors. You can override the error if the Patient Cart is plugged into AC power. da Vinci® Si™ Appendix A: Error Handling A.3 Conversion to Open Surgery If a situation arises where a conversion to open surgery is required, perform the following steps to remove the system from the patient: 1. Remove the instruments and endoscope from the patient. Note the following: a. In case of system failure while the instrument is grasping tissue, the grips can be manually opened by following the grip release instructions, see Grip Release on page 9-13 (Chapter 9, Patient Cart Use). WARNING: Do not perform grip release on a non-faulted system without first pressing the Emergency Stop button. Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism. WARNING: Rotating the grip release tool too far and/or in the incorrect direction can cause unintended instrument motion or damage to the grip release mechanism. 2. Disconnect the cannulae from the instrument and camera arms. 3. Move the instrument and camera arms away from the patient. Note: If the system is in a fault state while converting to open surgery, the Patient Cart will still allow use of the port clutch buttons. If the system loses all power, the arms and setup joints may be overpowered to move the arms as necessary. _________________________________End of section______________________________ 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note: Whenever possible, use Surgeon Console control to release the instrument grips. da Vinci® Si™ A-5 B-1 Appendix B: da Vinci Si-e Surgical System Appendix B: da Vinci Si-e Surgical System This appendix provides detailed information and specifications for the da Vinci Si-e Surgical System, an upgradable configuration of the da Vinci Si System, visibly distinguished by a 3-arm Patient Cart. The da Vinci Si-e System is designed to be upgradable anytime to a full-featured da Vinci Si System (single or dual console) – by Intuitive Surgical technicians. This section describes the characteristics that distinguish it from the da Vinci Si System. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL B.1 System Component Compatibility The da Vinci Si-e System uses the same Surgeon Console, which is interchangeable with any da Vinci Si System. In contrast, the 3-arm Patient Cart and the Vision Cart of the da Vinci Si-e System are not interchangeable with the 4-arm Patient Cart and Vision Cart of a da Vinci Si System; the specific da Vinci Si-e System components must be used together for the da Vinci Si-e System to work. The system software recognizes when you connect an incompatible combination of Patient Cart and Vision Cart, notifies you on screen and prevents use of the disallowed combination. Note: The da Vinci Si-e System does not support dual console surgery. da Vinci® Si™ Appendix B: da Vinci Si-e Surgical System The da Vinci Si-e System supports use of external monitors in high definition or standard definition, by means of the standard video out connectors on the back of the Core, the Surgeon Console, and the Camera Control Unit (CCU). The table below describes the available video output options on the back of the Core. These are not user-configurable: you cannot select the video output format of the Video Out bay Aux connectors (back of the Core). The da Vinci Si-e System selects the appropriate output format based on the device connected to the Aux connector. See section 4.5 Video and Audio Connections and section H.5 Video Patch Panels for more details. Table B-1 Si-e Video Connections Component Connector Output Format Video Out bay Aux, back of DVI (analog and digital) Core Resolution Overlay Composite (analog) S-Video (analog) XGA, SXGA, WXGA+ or 720p, automatically configured NTSC or PALa NTSC or PALa Surgeon’s view Surgeon’s view Surgeon’s view SD-SDI (digital) NTSC or PALa Surgeon’s view a. NTSC or PAL is standard definition and is determined by country. The Video Out bay Aux supports only one video format at a time. Note: Video outputs make available only the surgeon’s view overlays. No external monitor used with the da Vinci Si-e System can support the touchscreen overlays nor functionality of the da Vinci Si System. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Use of Third-Party Monitors Note: If the system has OnSite installed, the OnSite status icons will be present on the Vision Cart monitor even though the touchscreen function is not available. All other OnSite features are supported on the Si-e System. da Vinci® Si™ B-2 B-3 Appendix B: da Vinci Si-e Surgical System B.2 da Vinci Si-e Differences Users of the da Vinci Si-e System should note the following differences in features and behavior compared to the da Vinci Si System. The da Vinci Si-e System has only two instrument arms, as reflected on the touchpad display: Figure B.1 Two instrument arms appear on touchpad Audio System 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Two Instrument Arms Since the monitor includes a microphone and speakers, it provides support for two-way audio communication between the surgeon and patient-side assistant. For the da Vinci Si-e System, the volume control slider for the Vision Cart speakers is found on the Audio tab of the touchpad, to the right of the Surgeon Console speaker control. Note that there is no microphone mute button; to mute the microphone, drag the slider all the way to the left, as shown. da Vinci® Si™ Vision Cart speaker volume Surgeon Console speaker volume Figure B.2 Speaker volume control is on touchpad Audio tab TilePro Not Available TilePro (multi-image) mode is not available with the da Vinci Si-e System, and thus the option is not present on the Display Preferences screen of the touchpad. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Appendix B: da Vinci Si-e Surgical System Figure B.3 TilePro not present da Vinci® Si™ B-4 B-5 Appendix B: da Vinci Si-e Surgical System Figure B.4 TilePro QuickClick option not present Telestration Not Available Since telestration is done on the touchscreen, telestration is not possible with the da Vinci Si-e System. However, note that the selected Display Eye option on the Display Preferences screen (Figure B.3) does still determine whether the surgeon’s left (L) or right (R) eye image from the stereo viewer passes out of the video connectors of the Core’s Video Out bay Aux. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Furthermore, the QuickClick option for TilePro activation is not offered on the touchpad Control Preferences screen. da Vinci® Si™ Appendix B: da Vinci Si-e Surgical System Camera / Scope Setup via Touchpad Only Figure B.5 Camera / Scope Setup on the touchpad Follow these steps to calibrate the endoscope assembly from the touchpad of a da Vinci Si-e System: 1. The sterile person should insert the endoscope tip fully inside the endoscope alignment target, using the proper hole, which depends on the tip angle, so that the target crosshairs are visible on the center of the stereo viewer. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL On the Si-e System, no touchscreen dictates that camera / scope setup must be done via the touchpad. This circumstance also requires two people to perform calibration: one sterile person to handle the endoscope and a second non-sterile person to work the touchpad at the Surgeon Console. Note: For 3D calibration to be successful, the crosshairs must be well centered on screen and the target must be kept as still as possible on the endoscope. 2. The non-sterile person at the touchpad: From the Video tab, go to Camera / Scope Setup and then touch the 3D Calibration button. The button name changes to Finish Calibration and “Adjust as necessary” appears next to it, and the button and all arrow buttons flash to prompt your input. da Vinci® Si™ B-6 Appendix B: da Vinci Si-e Surgical System Figure B.6 3D Calibration in progress 3. Touch the arrows on the touchpad to move the green crosshairs until aligned with the magenta crosshairs, as seen in the stereo viewer. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL B-7 4. To save the calibration setting and exit calibration mode, touch Finish Calibration. 3D Calibration and Camera Head Button Functionality For the da Vinci Si-e System, the camera head buttons do not support 3D calibration. Without a touchscreen, you must perform 3D calibration from the touchpad, as described above. The Vision Setup button, in particular, supports no functionality at all; when you press it the system gives an error beep, but does not display a message. Nothing happens except the error beep. The Focus In and Out arrow buttons still support focusing of the surgical image from the camera head, and the Lamp On/Off button still functions. _________________________________End of section______________________________ da Vinci® Si™ Appendix C: Illuminator Information C Appendix C: Illuminator Information C.1 General Safety Precautions Before operating, read all safety instructions. See Endoscopic Procedure Precautions on page 10 for additional safety instructions regarding use of the Illuminator. The Illuminator is a source of high electrical voltage, intense light and heat. When used properly and with normal precautions, it is a safe and effective light source. CAUTION: Third party light guides may not withstand light output levels of this light source. Do not operate the light source without lamp module in place. Disconnect power supply cord before servicing to avoid electric shock. To reduce risk of electric shock, do not remove cover. Refer servicing to Intuitive Surgical personnel. CAUTION HOT. Do not remove lamp immediately after operation. Allow lamp to cool 5 minutes with fans running before removing power to the Illuminator. The end of the light guide may be hot. Keep cooling vents free from obstructions. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL This appendix provides detailed information and specifications for the integrated Illuminator, also known as the Y1903 Xenon Fiber-Optic Light Source. To prevent overheating, replace only with the same type and rating of lamp module. Read instructions before replacing lamp module. (See 12.3 Illuminator Lamp Module Replacement on page 12-2.) The following label appears on the side of the lamp module above the removal handle. Note: It may be necessary for the reader to be as close as 6 in (15 cm) from the label to read this information. Caution: Hot Figure C.1 Lamp module label Observe the caution statement on the label: “CAUTION: High-pressure lamp may explode if improperly handled. Refer servicing to qualified service personnel.” The label provides space to indicate the “SERIAL NO.” and “MODEL NO.” of the lamp module. “LIGHT OUTPUT ” indicates that the lamp light emits from the side indicated by the arrow. da Vinci® Si™ C-1 C-2 Appendix C: Illuminator Information Refer to Figure 12.2 on page 12-4 to see an image of the lamp module replacement label affixed to the top of the lamp module. Figure C.2 Illuminator front features 1. Optic Adapter: Accepts Olympus™ fiber-optic light cables. 2. LED Indicator: Shows the lamp status. Amber: Lamp off; Blue: Lamp on; Blue blinking: No scope selected or detected. 3. Lamp On/Off Switch: Toggles the lamp on/off once the system has been powered up. This button switch on the front panel is symbolized by an incandescent lamp. When pushed, the blue “OFF” flashes on the display until lamp ignition occurs. 4. Display Window: Displays light output level from 0-100 in 10% increments when lamp is on, and will read OFF when lamp is off. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL C.2 Illuminator Features 5. Lamp Hours: Displays number of usage hours on the lamp module. To read the lamp hours, press the decrease (–) and increase (+) buttons simultaneously, and read the number displayed on the display window. You may also view lamp hours by selecting Utilities > Inventory Management on the touchscreen or touchpad, as described in sections 7.2 and 10.3. 6. Intensity Control (– +): Control buttons to increase or decrease light output levels in 10% increments. da Vinci® Si™ 7 12 10 11 13 Figure C.3 Illuminator rear features 7. RS232 I/O Serial Port: 9-pin D Sub-Miniature interface for RS232 control features. Labeled “Illuminator Control.” 8. Input Power Module: Consists of the Power On/Off switch, fuse drawer, and AC input power receptacle. 9. Power On/Off Switch: The Power On/Off Switch is located on the back panel. When switched ON, the system is energized and initiates standby mode, while the LED indicator (on front) illuminates amber. In addition, the cooling fans run, and the display reads OFF. When switched OFF, the system is de-energized, the LED indicator (on front) is not illuminated, and the display is dark. Energizing the system does not automatically turn the lamp on. 10. Fuse Drawer: The fuse drawer is located on the back panel beside the AC input power receptacle. The fuse drawer contains two 6.3 amps main fuses. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Appendix C: Illuminator Information 11. AC Input Power Receptacle: The AC input power receptacle, located on the back panel, is a three-prong receptacle that accepts a detachable AC power cord. 12. Unit Identifier Label 13. Light Source Label: Shown below. da Vinci® Si™ C-3 C-4 Appendix C: Illuminator Information Figure C.4 Light source label example 14. Lamp Module Access Drawer: Allows service technician access to the lamp module for replacement. (See 12.3 Illuminator Lamp Module Replacement on page 12-2.) By pushing in on the drawer, the latch mechanism will release, and the drawer will slide forward. To close the drawer, push it in until the latch catches. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note: It may be necessary for the reader to be as close as 6 in (15 cm) from the label to read this information. 14. Lamp module access drawer Figure C.5 Lamp module access drawer open da Vinci® Si™ Appendix C: Illuminator Information C.3 Basic Troubleshooting Table C-1 Basic Troubleshooting Possible Problems Remedy • • No power to Illuminator • • Vision Cart not connected or not powered on. Fuse is blown. Internal power supply not operating. AC input power receptacle unplugged. • Connect and power on system. • Replace fuse. • Contact Intuitive Surgical Technical Support. • • No light emits from unit • • Lamp module access drawer open. Lamp burned out. Internal power supply not operating. Fiber-optic cable not connected. • Close drawer. • Replace lamp module. • Contact Intuitive Surgical Technical Support. • Connect fiber-optic cable correctly. Lamp flickers or dims Field of view is dim Lamp is getting old. Incorrect settings. Replace lamp module. Adjust Brightness controls • Obstructed air intake leads to overheating, causes • Allow unit to cool 10 minutes. Illuminator turns off Remove obstructions. thermal switch to trip. after a few minutes of • Fan not running; overheating causes thermal • Contact Intuitive Surgical Technical operation. switch to trip. Support. C.4 Fuse Replacement 1. Switch power off on the back of the Illuminator and remove the power cord from the back of the Illuminator. 2. Check for blown fuses by removing the fuse cover, located next to the three-prong power receptacle. Carefully pull out the cover using a flat blade screwdriver (medium size) or equivalent, as shown in Figure C.6. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symptom Figure C.6 Remove fuse cover 3. Replace blown fuse(s) with the same size and rating: 6.3A time delay: T6.3A fuses, size 5x20mm. da Vinci® Si™ C-5 C-6 Appendix C: Illuminator Information 4. Re-install the fuse cover. 5. Reconnect the power cord 6. On the back of the Illuminator, turn the power switch on. The Illuminator should be operative again. C.5 Specifications of Y1903 Light Source Note: The specifications in this section apply to the Y1903 Illuminator only and not the da Vinci Si System. Table C-2 Y1903 Light Source Specifications Category Specification Comments Electrical Input 100 - 240 VAC, 50/60Hz universal, 6.0A input Located on rear panel, dual fuses IEC320, 6’ (1.83m), configured for locale Input Voltage AC Power Connector Line Cord Performance and Features • 2450 Lumens nominal initial output using Olympus™ fiber. • Spectral output 386 - 733nm nominal • <10% instability p-p through 6 mm glass rod @ 0-100Hz • Beam profile to have “smooth” distribution with no shadows or sharp peaks Light Output All light output specifications refer to “system only” performance. Light output via optical fibers or other optical components may vary. Automatic shutdown in the event of overheating Over-temperature Protection 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Contact Intuitive Surgical Technical Support if the unit fails to operate properly again. Unit to become fully operational <3 minutes (target) after thermal shutdown and all Overheat Recovery / Auto obstructions to air flow removed at Cool environmental temperature of <22 °C (72 °F) Fiber-Optic Connection Safety Feature Fans will remain on in the event of thermal shutdown when power is on. Lamp must be switched on by using Lamp On/Off switch located on front panel. • Lamp will not ignite unless a fiber-optic cable is Fans will remain on in the fully inserted into the active port on the turret absence of a fiber-optic cable • Lamp power is cut or blocked if fiber-optic cable is inserted into active port when removed from active port to prevent accidental power is on light leakage Lamp Power Supply Lamp Module Lamp Module Replacement Lamp Life PS300-12 type Cermax VQ (300 Watt) By easy access to lamp module via drawer. No tools required. • 1000 hours to 50% of initial output specification measured through 6 mm glass rod • >1000 hours at a minimum output of 1225 Lumens da Vinci® Si™ Intuitive Surgical PN 950093 Lamp replacement drawer “interlocked” for safety. Lamp power will be cut when drawer is opened Appendix C: Illuminator Information Table C-2 Y1903 Light Source Specifications Category Specification Comments User Interface / Control In this system user manual Located on front panel Lamp On/Off Switch User controlled lamp on/off. Fan operation independent of lamp status. Olympus™ port to fit Olympus fiber Fiber-Optic Adapter • Controlled by membrane buttons on front panel • (+) and (–) buttons for relative intensity increments Light Attenuation Shutter • Relative level of illumination indicated by a digital numeric display (blue numerals) Displays number of elapsed hours of lamp operation when you press (+) and (–) buttons at same time Lamp Hour Counter Mechanical & Environmental Dimensions Weight Touch Temperature Ground Bound Sterilization Operating Temperature 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL User instructions Storage Temperature Operating & Storage Humidity Operating Pressure Audible Noise Shipping, Shock & Vibration Cooling Height 5.5" (Without Feet) x Width 15.5" x Depth Designed for modular ≤17” (without front bezel) (14 x 39.4 x 43.2cm) expansion ≤28 lbs. Per UL60601 -1 Per UL60601 –1 The light source may be wiped-down with hospital approved disinfectants (for example, 10% bleach + 90% water solution) applied with a damp cloth (must not be wet) 6 °C to 35 °C –20 °C to 75 °C 10 - 80% relative humidity, non-condensing 1 Atmosphere ≤ 40dB per ISTA 3A Vents to direct airflow toward the back of the unit Regulatory Approvals • • • • Compliance to standards • • • • • IEC 60601-1:1988+A1:1991+A2:1995+A1.3:1997 UL 60601-1:2003 EN 60601-1:1990+A1:1993+A2:1995+A1.3:1997 EN 60601-1-2:2001 CAN / CSA C22.2 No. 601.1/M90(R1997),B/98,S1-94 ANSI/AAMI ES60601-1: 2005 CAN/CSA-22.2 No. 60601-1 (2008) EN 60601-1-2: 2007 CE mark da Vinci® Si™ C-7 C-8 Appendix C: Illuminator Information C.6 Classification of the Y1903 Light Source • Class I: The light source relies on connection to the protective earth conductor to prevent shock hazards. Note: The da Vinci Si camera head provides isolation in accordance with a CF applied part and is acceptable for use with the Y1903 Illuminator. • Provides no protection against ingress of liquids. • Mode of Operation: Suitable for continuous operation. • Not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or with nitrous oxide. C.7 Electromagnetic Compatibility The Y1903 has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001(E). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The Y1903 generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. It can be determined if this equipment causes interference by turning the power to the light source off and on. The user is encouraged to try to alleviate interference problems by one or more of the following measures: • Re-orient or relocate the receiving device • Increase the separation between the equipment. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL • Type BF: The Y1903 light source is classified as a BF equipment. The optic adapter is grounded and only BF or CF applied parts should be used with the Y1903. • Connect the equipment into an outlet on a separate electrical circuit from that of other devices. da Vinci® Si™ Appendix C: Illuminator Information Warnings • The Y1903 should not be used adjacent to or stacked with other equipment. However, if adjacent or stacked use is necessary, the Y1903 should be observed to verify normal operation in the configuration in which it is used. Manufacturer’s declaration – electromagnetic immunity The Y1903 is intended for use in the electromagnetic environment specified below. The customer or the user of the Y1903 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL • AC power cords other than those provided with the instrument may result in increased emissions or decreased immunity. Compliance Level ±6 kV contact ±8 kV air Complies ±2 kV for power supply lines ±1 kV for input/ output lines Complies ±1 kV line(s) to line(s) ±2 kV line(s) to earth Complies <5% UT (>95% dip in UT) Complies for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles Voltage dips, short 70% UT (30% dip in UT) for interruptions and voltage 25 cycles variations on power supply <5% UT (>95% dip in UT) input lines for 5 sec. IEC 61000-4-11 3 A/m Complies Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Note: UT is the AC mains voltage before application of the test level. da Vinci® Si™ Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Y1903 requires continued operation during power mains interruptions, it is recommended that the Y1903 be powered from an uninterruptible power supply or battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. C-9 C-10 Appendix C: Illuminator Information Manufacturer’s Declaration – Electromagnetic Emissions The Y1903 is intended for use in the electromagnetic environment specified below. The customer or the user of the Y1903 should assure that it is used in such an environment. Compliance Group 1 RF emissions CISPR 11 Class B RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Class B Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Electromagnetic environment guidance The Y1903 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 Y1903 is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. _________________________________End of section______________________________ 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Emissions test da Vinci® Si™ Appendix D: VisionBoom™ Use Instructions D Appendix D: VisionBoom™ Use This appendix provides instructions to use the da Vinci Si Surgical System installed in the VisionBoom configuration. Integrators seeking installation instructions should refer to the VisionBoom™ Installation Guide (PN 550539). Note: This appendix provides only those instructions specific to the VisionBoom configuration. Refer to relevant portions of this manual for instructions to use the surgical system. The da Vinci Si VisionBoom configuration eliminates clutter and improves efficiency in operating room (OR) surgical environments by replacing the da Vinci Vision Cart, and its associated cords and cables, with a convenient ceiling-mounted system. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Instructions Figure D.1 Recommended side by side (left) and stacked (right) VisionBoom configurations Note: The VisionBoom upgrade supports dual console surgery. The ceiling-mounted equipment boom is the primary platform for OR integration and, depending on the model selected, the typical boom can provide the support and space to position most necessary clinical devices. The equipment boom is not a product sold by ISI but by manufacturers such as Berchtold™, Steris™, Skytron™, etc., to name just a few vendors that sell such equipment. da Vinci® Si™ D-1 D-2 Appendix D: VisionBoom™ Use Instructions D.1 General Notes and Cautions • Air flow sufficient to support adequate cooling of da Vinci vision components is critical to their proper function. The entire da Vinci System is designed to undergo an automatic, controlled power-down sequence in case a component or subsystem overheats while in normal operating mode, thereby preventing system damage. (See Chapter 5 Startup for details.) To avoid overheating, do not place anything on or near any da Vinci vision component on the boom, especially if it might impede air flow. Do not route cables behind the Illuminator on the boom shelf, to avoid blocking air flow behind it. • ISI recommends that the boom be oriented during surgery so that air flow from the components is directed away from the sterile field. • ISI recommends that da Vinci vision components be left permanently in the configuration in which they are transferred to the boom by ISI service personnel. Rearrangement of da Vinci vision components could result in a configuration that does not support adequate cooling or otherwise may result in an increased risk of damage to or improper function of the components. • da Vinci vision components are not designed to support external loads, and therefore ISI discourages placement of any equipment on top of da Vinci vision components mounted on the boom shelf. CAUTION: To avoid overloading circuits, do not connect ancillary devices such as insufflators or energy devices in common circuits with any system component, particularly not with the vision components because they have large power requirements. Ancillary devices must be connected to boom outlets on separate circuits from all system components. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note: CAUTION: After a few minutes of use, the rear of da Vinci vision components may become hot, particularly the Illuminator. Avoid touching the rear of these units during use and for 10 minutes after use while components cool with internal fan operation. D.2 da Vinci Si System Connections In a VisionBoom configuration, Surgeon Consoles and the Patient Cart connect to the Core via fiber interface wall plates. These wall plates connect via cabling inside the wall that terminates in the fiber boom plates, which connect via their blue cables (1 m) directly to the back of the Core. Surgeon Consoles and the Patient Cart can connect to any da Vinci wall plate in the room. The Core recognizes the units connected to its fiber input ports automatically. Figure D.2 illustrates how the system connections are made. da Vinci® Si™ Appendix D: VisionBoom™ Use Instructions Wall plate Fiber cable da Vinci Patient Cart Boom plates Fiber cable Wall plate Equipment boom with Core Fiber cable Fiber conduit through walls/ceiling Figure D.2 Fiber cables and conduits connect Core to Patient Cart and Surgeon Consoles Figure D.3 shows where to find the fiber optic cable connectors on the rear of the Patient Cart and Surgeon Console. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL da Vinci Surgeon Console Figure D.3 Fiber connectors on Patient Cart and Surgeon Console Connecting the Fiber Cables Note: The connections on the back of the Core (in Step 4: Connect Core, page 5) generally are made only once and left connected unless the Core is removed from the boom. da Vinci® Si™ D-3 D-4 Appendix D: VisionBoom™ Use Instructions Follow these steps to connect the Patient Cart and one or two Surgeon Consoles to the Core in the VisionBoom configuration. Before connecting the blue da Vinci Si fiber cables, pull to remove the protective cap at each end of the cable (Figure D.4). Note the position of the red alignment mark on the uncapped cable end, which you must align with a similar mark on the fiber cable port for successful insertion. Red alignment mark End cap on system cable Uncapped end of cable Figure D.4 Remove the cable end cap Step 2: Connect Patient Cart Connect a blue fiber cable (20 m) to the back of the Patient Cart (Figure D.5) and to the desired fiber interface wall plate (Figure D.6). When lit solid blue, the LED above the fiber port indicates a good connection to the Core. (It will not light blue until you complete the connection from the boom plate to the Core – see Step 4: Connect Core, page 5.) Blue light shows good connection when complete to Core 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Step 1: Remove Cap Observe red mark and align Flip up receptacle cover & insert Figure D.5 Connect fiber cable to Patient Cart da Vinci® Si™ Align red marks and push in to connect Figure D.6 Connect other end of fiber cable to fiber wall plate Step 3: Connect Surgeon Consoles For each Surgeon Console you will use, connect a fiber cable to the fiber connector on the back of the console (Figure D.7) and to an available fiber wall plate (as in Figure D.6). Again, a blue LED indicates a good connection to the Core when connections in next step are complete. Blue light shows good connection when complete to Core 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Appendix D: VisionBoom™ Use Instructions Figure D.7 Connect fiber cables to each Surgeon Console Step 4: Connect Core Connect each 1 m (3’-3”) cable being used from its boom plate to the back of the Core to complete the connections for each Surgeon Console and the Patient Cart (Figure D.8). Blue LEDs show good connections Figure D.8 Connect the boom plate fiber cables to the Core on the boom da Vinci® Si™ D-5 D-6 Appendix D: VisionBoom™ Use Instructions Figure D.9 Bypassing wall cabling 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note: If, after connecting all cables as shown in steps 1 through 4, you still do not have a good connection (no blue light) connect the long (20 m) blue fiber cables directly to the core. These blue fiber cables are of sufficient length (20 m) to bypass the wall cabling and connect directly to the core from the surgeon console and patient cart, as illustrated in Figure D.9 below. da Vinci® Si™ Appendix D: VisionBoom™ Use Instructions D.3 Optional Core Connections This section describes the additional, optional connections you can make between the Core and third party devices. Perform this step for each video connection you wish to make between the da Vinci Si System and external monitors, recorders or other third party devices. 1. Connect each video output or TilePro input on the back of the Core to the desired interface plate, monitor, or third party device. Figure D.10 shows a typical connection from the DVI output to a DVI boom interface plate that supports connection to an OR video switching system. Core DVI output DVI boom plate Figure D.10 Example of DVI connection from Core to boom plate 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Core Video Connections Electrosurgical Unit (ESU) Connections Note: Refer to 4.4 Auxiliary Device Connections, page 4-9, for detailed instructions. To connect one or more electrosurgical units (ESU), perform this step: 1. Connect the appropriate energy activation cable between any of the Energy receptacles on the back of the Core and the appropriate connectors on the ESU. Core Energy connection Sample ESU connections Figure D.11 Example of ESU connection to Core da Vinci® Si™ D-7 D-8 Appendix D: VisionBoom™ Use Instructions D.4 Camera Head and Cable Storage Coil camera cables Hang cables over holster As when finished Figure D.12 Camera and cable storage using the boom-mounted holster D.5 Touchscreen Positioning 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL The camera holster is installed on the boom to provide a convenient location for storing the camera head (without endoscope attached) when not in use. Figure D.12 illustrates how to coil the cables and store the camera head. The da Vinci Si touchscreen mounted on the boom can be positioned to either side of the boom or directly off the front (Figure D.13). Position it according to the needs of the surgical staff. Unless a sterile monitor drape is used, a sterile assistant requires a change of surgical gloves after touching the touchscreen; alternatively, non-sterile surgical staff may operate an undraped touchscreen. Figure D.13 You can position touchscreen Note: Refer to 7.4 Working with the Touchscreen Vision Controls, page 7-15, for instructions to use the touchscreen. da Vinci® Si™ Appendix D: VisionBoom™ Use Instructions Similar to the positioning of the Vision Cart in relationship to the patient, the vision boom needs to be positioned to a location that is convenient to the surgical staff to have access to the equipment. The vision boom positioning also must take into consideration the location of the third da Vinci instrument arm during the specific procedure performed. The boom must be placed within reach of the 5.75 m (18’-6”) camera cable attached to the front of the Core. VisionBoom components 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL D.6 Boom Positioning Figure D.14 Typical boom positioning _________________________________End of section______________________________ da Vinci® Si™ D-9 E-1 Appendix E: OnSite™ for da Vinci® Surgical System Appendix E: OnSite™ for da Vinci® Surgical System E.1 General Information The following appendix is applicable only if your da Vinci Si System has da Vinci OnSite enabled. Contact Information For Customer Service and Reporting of Complaints or Adverse Events Use the following information for customer service, including ordering, reporting complaints or adverse events, and general information regarding Intuitive Surgical or our products and services. In the U.S. In Europe: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA Toll free: 1.800.876.1310 Direct: 408.523.2100 Fax: 408.523.2377 Intuitive Surgical Sàrl 1, chemin des Mûriers, 1170 Aubonne, Switzerland Toll free: +800.0821.2020 Direct: +41.21.821.2020 Fax: +41.21.821.2021 For Technical Support If the system requires maintenance or service, please call our Technical Support line. In the U.S., call 1-800-876-1310, where phones are staffed 24 hours a day, seven days a week. In Europe, call +41.21.821.2020. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Manufacturer Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA www.intuitivesurgical.com Intuitive Surgical Sàrl 1, chemin des Mûriers, 1170 Aubonne Switzerland General Precautions, Warnings, and Contraindications Note: All da Vinci Surgical System users must follow all instructions for use supplied with the system, its components, instruments, and accessories. This includes the following documents: Instruments and Accessories User Manual (PN 550675), Reprocessing Instructions (PN 550875), and any instructions for use (IFUs) provided with instruments or accessories. WARNING: Be sure to read and understand all information, particularly the caution and warning information, found in the applicable user manuals before using these products. Failure to properly follow all instructions, including those in the da Vinci Surgical System user manual, and instructions supplied with accessory devices such as generators, may lead to injury and result in improper functioning of the device. da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System CAUTION: Leakage current from interconnected electrical equipment may exceed safe levels. To maintain the safety of patients and users, interconnect only with devices in compliance with IEC 60601-1-1. It is the user’s responsibility to ensure that any interconnected equipment not supplied by Intuitive Surgical maintains compliance with IEC 60601-1-1. CAUTION: Ethernet networks (both wired and wireless) are subject to losses of connectivity that could disrupt use of OnSite or make data unreliable when it is received at a remote location. Such disruptions, if they occur, have no effect on the performance or functionality of the da Vinci Surgical System. E.2 Indications for Use – OnSite OnSite for da Vinci Surgical Systems is an accessory indicated for use by trained Intuitive Surgical Field Service personnel to: (1) obtain system information for the purpose of diagnosing faults, (2) remotely enable/disable features including configuration updates through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital’s Internet Protocol (IP) infrastructure. E.3 Network Connections OnSite requires a wired RJ45 Ethernet 10bT/100bT and/or wireless 802.11 network connection with Internet access where the da Vinci Surgical System will be used. E.4 Transmitter Module Label 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL CAUTION: OnSite components may be installed and serviced only by Intuitive Surgical personnel. Do not attempt to install or service equipment without Intuitive Surgical personnel. When the optional wireless bridge is installed, the following Federal Communications Commission (FCC) identification label will be affixed to the Surgeon Console. Contains Transmitter Module FCC ID: SWX-NS2 Figure 1 Transmitter Module Label da Vinci® Si™ E-2 E-3 Appendix E: OnSite™ for da Vinci® Surgical System E.5 Introduction 1. Automated log retrieval, where da Vinci Surgical System uploads logs to an Intuitive Surgical server when idle 2. Remote system status monitoring 3. Remote diagnostics and servicing 4. Remote configuration changes 5. Enable/disable device features The monitoring capability enables a faster response time from the da Vinci dVSTAT™ (da Vinci Surgery Technical Assistance Team) for problem resolution, real time diagnosis, and increased diagnostic accuracy. To implement remote service capabilities, the da Vinci Surgical System must have access to the Internet. OnSite is designed to accomplish this using existing hospital networks. E.6 OnSite System Requirements and Connections The remote servicing features of OnSite are designed to be highly secure and to function transparently. The da Vinci Surgical System communicates with an Intuitive Surgical server via outgoing network connections to enable Intuitive Surgical service personnel to remotely monitor and service the system while in use. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL OnSite provides connectivity that enables Intuitive Surgical service personnel to remotely service the da Vinci Surgical System pre-operatively and intra-operatively. It enables the following capabilities. da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL In summary, OnSite consists of three major components, namely the da Vinci Surgical System with installed networking components, the Intuitive Surgical server, and the remote user (Intuitive Surgical Field Service personnel). The block diagram below illustrates the OnSite networking infrastructure. Figure 2 OnSite Networking Infrastructure Note: To take advantage of the full potential of OnSite, the system must remain connected to the network. da Vinci® Si™ E-4 E-5 Appendix E: OnSite™ for da Vinci® Surgical System Wired Network Connection Figure 3 Network Security Device To establish a wired connection: Connect the da Vinci Ethernet connection to the hospital network (wall plate) using a CAT5e industrial style network cable. Ethernet to hospital network (wall) Connects da Vinci System to network 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Intuitive Surgical field service personnel install a network security device inside the da Vinci Surgical System, along with necessary cables and panels to enable a wired network connection for OnSite. Figure 4 Network Cable Connections (da Vinci Si) da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System Optional Wireless Connection Figure 5 Network Security Device with Wireless Bridge Note: External connections are not required for the da Vinci Si Surgical System. 5.7 Disabling All Network Connectivity If there is a need to disable all network connectivity for the da Vinci Si System, open the back of the Vision Cart and disconnect the RJ-45 (Ethernet) connector at bottom center of the Core, indicated below. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL There is an optional wireless connection available using the Network Security device and a Wireless Bridge. See Section E.10 Wireless Connectivity Option and section E.13 OnSite Appendix C: Wireless Bridge Data for details on wireless connectivity. Disconnect to disable networking Figure 6 RJ-45 Connector – Core (da Vinci Si) Note: This action disables all network connectivity for the da Vinci Si System, but it does not power off the wired or wireless networking equipment. Note: To re-establish network connectivity, you must re-connect the indicated RJ-45 connector on the back of the Core. da Vinci® Si™ E-6 E-7 Appendix E: OnSite™ for da Vinci® Surgical System E.8 Automatic Status and System Log Retrieval OnSite provides real-time system status monitoring and post-procedure upload of system logs, for the support team to service the da Vinci System. When Intuitive Surgical field service personnel enable the OnSite functionality, the da Vinci Surgical System can: A. Provide status updates – typically every 10 seconds but can be configured for different intervals B. Upload all system logs to the Intuitive Surgical server after each procedure 2. Connect to field service diagnostic applications running on a remote laptop E.9 OnSite Servicing and Diagnostics OnSite enables remote servicing using current diagnostic applications that Intuitive Surgical Field Service personnel normally use when the technician visits on site. When physically present, the technician troubleshoots the system using a local connection between the laptop and the da Vinci System hardware. OnSite enables the technician to troubleshoot remotely, using the same set of diagnostic tools. Through a remote OnSite connection, the technician can interact with the system in either Normal Mode or Maintenance Mode. Normal Mode In Normal Mode, OnSite can only enable remote monitoring of system status. This allows dVSTAT to passively monitor information transmitted, with no ability to perform any activity that impacts the movement or performance of the surgical system. In Normal Mode, dVSTAT can: • Receive system logs • Check the condition of system switches and buttons 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL 1. Connect to an Intuitive Surgical server for these purposes: • Verify surgical instrument functionality. Normal Mode – OnSite Mode Indications While in Normal Mode, the da Vinci Si System indicates the status of the network connection. da Vinci Network Offline da Vinci Network Online OnSite Session In Progress Figure 7 OnSite Connection Status Indicators Note: Once the Ethernet cable is connected, it can take up to two minutes to detect the da Vinci network and update the status on the touchscreen. Maintenance Mode Note: Intuitive Surgical personnel can use Maintenance Mode only when they request it and are granted verbal permission by OR staff present with the da Vinci Surgical System. Maintenance Mode is a state where Intuitive Surgical technical support personnel can connect remotely to the da Vinci System to perform diagnostic and troubleshooting operations. da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System When in Maintenance Mode, the da Vinci Surgical System is not for human use. Intuitive Surgical technician requests for this service requires facility staff to place the system in Maintenance Mode at an agreed-upon time. Putting the System into Maintenance Mode • All system components are connected to AC power • Surgeon Console and Patient Cart system cables are connected to the Core When the system is in Standby Mode, the power buttons on the Surgeon Console, Vision Cart, and Patient Cart are lit amber. When an Intuitive technician connects to the system, they have the option to power on the system in Maintenance Mode. During an OnSite session in Maintenance Mode, the system displays: Maintenance Mode - Not for Human Use Remote Session in Progress System Servicing/ Diagnostics An example of an OnSite servicing capability that requires assistance and feedback from hospital personnel is when remotely testing the control and motion of the manipulators and robotic arms. Refer to the following illustration. Setup Joint Telescoping Axis 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL To put the system into Standby Mode, make sure the following conditions are met: Vertical range of motion Figure 8 Setup Joint and Instrument Arm The following list shows several diagnostic capabilities that an Intuitive Surgical field service technician can execute remotely when connected in Maintenance Mode via OnSite: 1. Test joints, internal sensors, and positioning potentiometers 2. Check condition of system switches and buttons 3. Check synchronization of system configuration 4. Modify system configurations 5. Perform arm motion and other diagnostic tests da Vinci® Si™ E-8 E-9 Appendix E: OnSite™ for da Vinci® Surgical System 6. Verify surgical instrument functionality 7. Check usage hour meter data Wireless Overview A wireless bridge is installed on the da Vinci Surgical System to enable the Wireless Connectivity Option. A hospital-supplied Wireless Access Point with Internet access is required to establish wireless connectivity. Wireless Network Requirements Intuitive Surgical field service personnel will install and configure the Wireless Connectivity Option. Below are the details of a suitable wireless network to support da Vinci wireless applications. Specifications • The Wireless Connectivity Option utilizes the IEEE 802.11 wireless standard using either 802.11b or 802.11g at 2.4 GHz Industrial, Scientific, and Medical (ISM) band. • The Wireless Bridge operates as a client to the hospital-supplied Wireless Access Point, transmitting data back and forth between the hospital network and da Vinci applications. • The Wireless Access Point must be located within 75 feet of the da Vinci Surgical System. Security • Wireless Network Infrastructure • 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL E.10 Wireless Connectivity Option Intuitive has tested the Wireless Connectivity Option in WPA2 pre-shared key mode with AES encryption, and recommends that the Wireless Connectivity Option is integrated into the hospital network using this security configuration. • OnSite Software Application • The OnSite Software Application uses a Secure Socket Layer (SSL) session based on unique certificates on the da Vinci System and the OnSite server. • Data being transmitted from the da Vinci Surgical System to the server is 128-bit encrypted. Quality of Service • Wireless Bridge • Maximum latency of 50 ms between the Wireless Bridge and the hospital-supplied Wireless Access Point • Wireless Channel that has 20% or less utilization • Overall Network • Maximum end-to-end packet loss of less than 10% • Network latency should not exceed 300 ms Once successfully installed and configured, Intuitive Surgical field service personnel conduct an end-to-end functional test to ensure that OnSite functions as expected. da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System It is possible that the wireless network conditions might degrade over time or experience periods of disturbance; da Vinci applications have been designed to be robust to typical network disturbances, but if an issue persists, contact Technical Support for assistance to resolve the issue. Note: Intuitive Surgical recommends that an active wired port be available when using the Wireless Connectivity Option. The configuration for the Wireless Connectivity Option provides a wired backup that the router will automatically activate when plugged in. Refer to E.11 OnSite Appendix A: IT Requirements for details on how to establish a wired connection. Note: It is important to note that if the wireless network is modified or updated after the Wireless Connectivity Option is installed, its suitability to support the wireless applications should be re-assessed. In particular, contact Technical Support if any of the following changes are planned or have occurred. • If the Wireless Access Point or da Vinci Surgical System is moved from the location where it resided during installation • If the Wireless Access Point is replaced with a new make or model Wireless Coexistence 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note: After installation, Intuitive Surgical recommends that the hospital routinely monitor to ensure that the Wireless Channel does not exceed 20% utilization, and the latency between the Wireless Access Point and the Wireless Bridge does not exceed 50 ms. If either exceeds the specified levels, contact Intuitive Surgical Technical Support. Wireless coexistence with other devices that transmit in the 2.4 GHz range is a concern since it can impact the reliability of the wireless link. This section summarizes testing conducted by Intuitive Surgical in an environment with other wireless devices representative of a typical Operating Room to demonstrate that the Wireless Connectivity Option functioned as expected. The test setup represented the worst case da Vinci Surgical System setup, and the position of the common wireless devices was defined to ensure that they were located near the Wireless Connectivity Option or the Wireless Access Point, and the path between the transmitter and receiver for most paired devices passed through the signal path between the Wireless Connectivity Option and the Wireless Access Point. Testing was conducted with a wireless network that satisfied the characteristics identified in Wireless Overview, page 9. The Wireless Access Point used during the testing was the Cisco Aironet 1240AG Series. The Aironet 1240AG Series was configured to operate as a typical Access Point, and therefore Wireless Access Points from other vendors should result in the same performance. Note that the characteristics for a suitable wireless network are summarized in Wireless Overview, and Intuitive Surgical field service personnel will confirm the wireless network is functioning as expected after installation. A complete list of the common wireless devices used during the testing (along with details on position, orientation, and type of data transmission) is summarized in the table in Common Wireless Devices Tested, page 11. da Vinci® Si™ E-10 Appendix E: OnSite™ for da Vinci® Surgical System Note: If different types of wireless devices will be used in the Operating Room, or if the wireless devices are used in different locations than what is described below, then Intuitive recommends that performance is tested with the wireless devices active, before use. If you encounter issues using the Wireless Connectivity Option in the presence of other wireless devices in the Operating Room, contact Intuitive Surgical Technical Support. Note: The wireless coexistence testing conducted by Intuitive does not cover use in the presence of MRI or diathermy machines. The Wireless Connectivity Option should not be used in the vicinity of these devices. Common Wireless Devices Tested Common Wireless Devices Disturbance Details IOGear Model: GUW2015V (receiver) GUWA200 (transmitter) Wireless Monitor 3.1 GHz to 4.8 GHz Certified wireless USB RF Modulation: QPSK/DCM; Data Rate: 480 Mbps 2 iPhone4 (3G and 2.4 GHz wireless) Samsung (2.4GHz wireless) Smart Phone/Device Test Setup Transmitter attached to a desktop PC located 50 inches away from the wireless bridge, and receiver attached to a monitor on the boom. Desktop PC oriented so the transmitter has clear line of sight to the receiver attached to the monitor, and PC streaming 720p video. One iPhone4 sitting on the arm rest of the Surgeon Console paired with a Bluetooth headset with a phone call in progress. The iPhone is also connected to the WAP. The second iPhone4 is paired with the Bluetooth speaker. Samsung phone in the room 72 inches away from a paired Bluetooth headset worn by someone at the patient side. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL E-11 Laptops with wireless 802.11 b; 2.4 GHz Two Dell laptops connected to the WAP on the same channel as the Wireless Bridge, with one laptop streaming a video over the network from YouTube. The laptops are approximately 90 inches away from the Wireless Bridge. Wireless keyboard and mouse Microsoft Wireless Desktop – Keyboard and Mouse 7000: 2.4 GHz range(2,400 – 2,483.5 MHz) FCC IDs C3K1345, C3K1142 and C3K1123 Wireless keyboard and mouse interfaced with one of the desktop computers, and physically sitting on top of the Vision Cart, 55 inches apart. Bluetooth keyboard Microsoft Bluetooth Mobile Keyboard 6000 2.4 GHz range(2,400 – 2,483.5 MHz) FCC ID C3K1390 Keyboard interfaced with one of the desktop computers, and physically sitting on top of the Vision Cart, 55 inches apart. 2.402-2.480 GHz range Jawbone headset paired with the iPhone4, worn by the surgeon at the Surgeon Console and used during the phone call. Bluetooth headset #1 da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System Disturbance Details Test Setup Bluetooth headset #2 2.402-2.480 GHz range Bluetooth headset paired with a Samsung phone, located on the operating room bed, 72 inches apart, with a call active. Bluetooth Speaker Creative D100 Wireless; FCC ID IBAMF8090 2.402-2.480 GHz range iPhone4 paired with the Bluetooth speaker playing music located on the operating room bed, 72 inches apart. Cordless Telephone Uniden 2.4 GHz Amplified Cordless Phone System (Clarity-4205) Phone base is on the desk, and the phone is on the other side of the room, with the base and phone continuously communicating. In the coexistence test, the microwave oven is placed in the signal path between the Wireless Bridge and the WAP, 20 feet away from the WAP. The Wireless Bridge and WAP are operating at maximum distance in this test. MagicChef Model MCD11E3W Output Frequency 2450 MHz; FCC ID C5F7NF1AMO100N Microwave Oven In the isolated test with the microwave oven, it is placed in the signal path between the Wireless Bridge and the WAP at a distance where no impact is observed, and then the Wireless bridge is moved closer until the connection is dropped. Wired connection is then established. In both test cases, the microwave oven is oriented such that the seams in the door are pointing toward the Wireless Bridge and the Wireless Access Point. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Common Wireless Devices Reader: TagMaster LR-3 Pro (PN 154400) 2.435 to 2.465 GHz range RFID tags ID-Tags: TagMaster S1255 MarkTag and S1240 MarkTag MeM 2.435 to 2.465 GHz range Covidien (formerly ValleyLab) Force FX (GSTElectro02) 390 kHz Electrosurgical Unit da Vinci® Si™ RFID was tested by placing the Reader and the ID-tags on each side of the signal path, between the Wireless Bridge and the Wireless Access Point. In the coexistence test case, the tags and reader were 30 inches apart. During the isolated test with the RFID setup, they were 36 inches apart in the worst case configuration. Located in the Vision Cart, which is placed as close to the Surgeon Console as possible. E-12 E-13 Appendix E: OnSite™ for da Vinci® Surgical System Devices Known to Interfere • Intuitive Surgical recommends keeping microwave ovens (1000 Watt) at least 25 feet from the Wireless Bridge or Wireless Access Point, especially if it is located in the signal path. Higher wattage microwaves should be placed at larger distances. • If a microwave oven causes interference, use the wired backup to correct the problem. 7.6 meters or 25 feet 7.6 meters or 25 feet Signal Path Wireless Access Point Wireless Bridge Figure E.1 Placement boundaries for microwave ovens 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Microwave Oven Testing conducted by Intuitive Surgical determined that microwave ovens can disrupt wireless communication in certain configurations: RFID Reader (2.4 GHz) Testing conducted by Intuitive Surgical determined that RFID readers operating in frequency hopping mode, or configured to operate at a frequency that overlaps the channel being used by the wireless bridge and the WAP, will cause minor network disturbances. To eliminate the interference, Intuitive Surgical recommends the following: • The RFID reader not operate in frequency hopping mode if it is being used in the same room as the Wireless Connectivity Option. • A separation of a least 4 MHz exists between the frequency range of the channel being used by the wireless bridge/WAP and the operating frequency of the RFID reader. For example, a wireless bridge/WAP operating on channel 10 spans 2.446 – 2.468 GHz; therefore, to avoid disturbances from the RFID reader, its operating frequency should be less than or equal to 2.442 GHz or greater than or equal to 2.472 GHz. Valid RFID Reader Operating Frequencies Valid RFID Reader 4 MHz Operating Frequencies 4 MHz Wireless Connectivity Option Frequency Range 2.442 GHz 2.446 GHz 2.468 GHz 2.472 GHz Figure 6 Valid RFID Reader Operating Frequencies da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System Addressing Wireless Connectivity Problems If you encounter connectivity problems while using the Wireless Connectivity Option, Intuitive recommends you do the following: • Determine if a device transmitting in the 2.4 GHz range is in the room, and if so, disable the device to see if it resolves the connectivity problems. • If you experience several disconnections, and the above step did not resolve the issue, or if the interfering device must be used, then establish a wired network connection with the da Vinci Surgical System (see Wired Network Connection for more information). E.11 OnSite Appendix A: IT Requirements Internet Access The network security device that will be integrated into the da Vinci Surgical System requires Internet access to contact servers at Intuitive Surgical. Intuitive Surgical requires a wired RJ45 Ethernet 10bT/100bT network drop and/or a wireless 802.11 network with Internet access in the OR where the facility’s da Vinci Surgical System is used. If your da Vinci Surgical System is used in multiple locations, then Intuitive Surgical requests that be made available in each location. OnSite is compatible with both DHCP and static networking addresses. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Note that RFID devices can operate outside the frequency range of what was included in the testing summarized above. If RFID devices operating outside the range shown above exist in the operating room, Intuitive Surgical recommends that performance is tested with the RFID device active, before use. Proxy Server OnSite is compatible with most proxy servers. In some instances proxy authentication maybe required to be by-passed. Firewall OnSite requires outbound port 443 open. Network Topology OnSite requires a minimum amount of bandwidth to post log files (generally less than 1 MB per day). da Vinci® Si™ E-14 E-15 Appendix E: OnSite™ for da Vinci® Surgical System E.12 OnSite Appendix B: Electromagnetic Compatibility The essential performance for da Vinci Wireless Connectivity during EMC testing was defined as follows during any of the required tests: • Video quality exceeded pre-defined metric demonstrating that the video quality was not impacted • Audio script test passed demonstrating that the audio link was not impacted • No changes in programmable parameters • No resets to factory defaults • No change in operating mode • No false alarms • No initiation of any unintended operation • No cessation or interruption of any intended operation Exception: For Voltage Dips and Interrupts, acceptance criteria is no component failures and is restorable to the pre-test state with operator intervention. For Radiated Immunity in the band 2.0 - 2.5GHz, acceptance criteria is no component failures and is restorable to the pre-test state with operator intervention, and restorable during test with a hard-wired connection. The da Vinci Surgical System complies with IEC60601-1-2:2001, General Requirements for safety – Collateral standard: Electromagnetic compatibility. Special precautions and installation information for the da Vinci Surgical System for electromagnetic compatibility (EMC) are provided in the following section. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL • No component failures Use only Intuitive Surgical-branded interconnection cables and accessories. Performance of cables or accessories other than those specified by Intuitive Surgical as replacement parts for internal components cannot be guaranteed. Any resulting damage to the system will not be covered under warranty. Equipment in the operating room, including the da Vinci Surgical System and other portable or mobile communications equipment, can produce Electromagnetic Interference (EMI), which may affect the function of these devices. Such effects are prevented by use of equipment with EMI characteristics proven below recognized limits, as identified in the below tables. In the event of suspected interference from other equipment, which prevents the proper functioning of the da Vinci Surgical System, contact Intuitive Surgical and/or discontinue use of the system until the problem can be remedied. The following Tables contain the Manufacturer’s declaration and additional information required by IEC60601-1-2:2001. da Vinci® Si™ Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Table 1: Manufacturer’s Declaration – Electromagnetic Emissions The da Vinci Surgical System is intended for use in the electromagnetic environment specified below. The customer or the user of the da Vinci Surgical 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 IEC 61000-3-3 Complies 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Appendix E: OnSite™ for da Vinci® Surgical System da Vinci® Si™ Electromagnetic Environment – Guidance The da Vinci Surgical 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 environment. The da Vinci Surgical System is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. E-16 E-17 Appendix E: OnSite™ for da Vinci® Surgical System Table 2: Manufacturer’s Declaration – Electromagnetic Immunity The da Vinci Surgical System is intended for use in the electromagnetic environment specified below. The customer or the user of the da Vinci Surgical System should assure that it is used in such an environment. IEC 60601 Test Level Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air Compliance Level ±6 kV contact ±8 kV air Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should ±2 kV for power supply lines ±2 kV for power supply lines be that of a U.S. commercial ±1 kV for input/ output lines ±1 kV for input/ output lines or hospital environment with highly reliable service. Electrical fast transient/burst IEC 61000-4-4 ±1 kV differential mode ±2 kV common mode Surge IEC 61000-4-5 <5% UT (>95% dip in UT) for Voltage dips, short 0.5 cycle 40% UT (60% dip in interruptions and voltage UT) for 5 cycles 70% UT (30% variations on power supply dip in UT) for 25 cycles <5% input lines IEC 61000-4-11 UT (>95% dip in UT) for 5 sec. ±1 kV differential mode ±2 kV common mode Mains power quality should be that of a U.S. commercial or hospital environment with highly reliable service. <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 U.S. commercial or hospital environment with highly reliable service. If the user of the da Vinci Surgical System requires continued operation during power mains interruptions, it is recommended that the da Vinci Surgical System be powered from an uninterruptedly power supply or a battery. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Immunity Test Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m Note: UT is the AC mains voltage before application of the test level. da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System Table 3: Manufacturer’s Declaration – Electromagnetic Immunity The da Vinci Surgical System is intended for use in the electromagnetic environment specified below. The customer or the user of the da Vinci Surgical System should assure that it is used in such an environment. Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Immunity test IEC 60601 test level Compliance level 3 Vrms 150 kHz to 3 Vrms 80 MHz 3 V/m 80 MHz to 3V/m 2.5 GHz Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the da Vinci Surgical System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 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 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 survey,a 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 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: 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 da Vinci Surgical System is used exceeds the applicable RF compliance level above, the da Vinci Surgical System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the da Vinci Surgical System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. da Vinci® Si™ E-18 E-19 Appendix E: OnSite™ for da Vinci® Surgical System The da Vinci Surgical System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the da Vinci Surgical System can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the da Vinci Surgical 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 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 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. Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Table 5: Compliance Information 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Table 4: Recommended separation distances between portable and mobile RF communications equipment and the da Vinci Surgical System Network Router: CAN/CSA-C22.2 No 60950-1-03 ANSI/UL Std No 60950-1 1st Ed. Wireless Bridge: * Wireless Data Rate 802.11b/g: 2.4-2.4835 GHz 802.11b/g: 2.4-2.4835 GHz * See OnSite Appendix C: Wireless Bridge Data on page 20 for more information da Vinci® Si™ Appendix E: OnSite™ for da Vinci® Surgical System NS2L DATASHEET SYSTEM INFORMATION Processor Specs Memory Information Networking Interface Atheros MIPS 4KC, 180MHz 16MB SDRAM, 4MB Flash 1 X 10/100 BASE-TX (Cat. 5, RJ-45) Ethernet Interface REGULATORY / COMPLIANCE INFORMATION FCC Part 15.247, IC RS210, CE YES Tolerance +/-1dB +/-1dB +/-1dB +/-1dB 6Mbps 9Mbps 12Mbps 18Mbps 24Mbps 36Mbps 48Mbps 54Mbps +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB 802.11b RADIO OPERATING FREQUENCY 2412-2462 MHz TX SPECIFICATIONS RX SPECIFICATIONS DataRate TX Power Tolerance DataRate Sensitivity 1Mbps 20 dBm +/-1dB 1Mbps -95 dBm 2Mbps 20 dBm +/-1dB 2Mbps -94 dBm 5.5Mbps 20 dBm +/-1dB 5.5Mbps -93 dBm 11Mbps 20 dBm +/-1dB 11Mbps -90 dBm 20 20 20 20 20 18 16 15 dBm dBm dBm dBm dBm dBm dBm dBm +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB +/-1dB 802.11g OFDM 802.11g OFDM 802.11b Wireless Approvals RoHS Compliance 6Mbps 9Mbps 12Mbps 18Mbps 24Mbps 36Mbps 48Mbps 54Mbps ADJUSTABLE CHANNEL SIZE SUPPORT 10MHZ 5MHz -92 -91 -89 -88 -84 -81 -75 -72 dBm dBm dBm dBm dBm dBm dBm dBm 20MHz RANGE PERFORMANCE Outdoor (BaseStation Antenna Dependent): Over 5km ANTENNA 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL E.13 OnSite Appendix C: Wireless Bridge Data Gain Polarization Polarization Selection Azimuth 8dBi (2400-2500MHz) Multi-Polarized Software Controlled Surival Wind 3dB Beamwidth Elevation 3dB Beamwidth Azimuth 216 km /hr 60 degrees 60 degrees Elevation Enclosure Size Weight Enclosure Characteristics Mounting Kit Max Power Consumption Power Supply Power Method Operating Temperature Operating Humidity Shock and Vibration PHYSICAL / ELECTRICAL / ENVIRONMENTAL 16.3 cm. length x 3.1 cm. height x 8cm. width 0.18kg Outdoor UV Stabalized Plastic Pole Mounting Kit included 4 Watts 12V, 1A (12 Watts). Supply and injector included Passive Power over Ethernet (pairs 4,5+; 7,8 return) -20C to +70C 5 to 95% Condensing ETSI300-019-1.4 SOFTWARE visit www.ubnt.com/airos 495-499 Montague Expwy. Milpitas, CA 95035 CA 95035 T(408)-942-3085 F (408)-351-4973 http://www.ubnt.com __________________________________End of Section_______________________________ da Vinci® Si™ E-20 F-1 Appendix F: 8.5 mm Endoscope for the da Vinci Si System Appendix F: 8.5 mm Endoscope for the da Vinci Si System This section provides details specific to the 8.5 mm 3D endoscope system designed to be used with the da Vinci Si Surgical System. It augments the information within this manual regarding endoscopes, especially under Endoscopesin section 7.1 Vision System Overview. Users should consider the following: • Users should have a thorough understanding of the use of the 12 mm endoscope system in conjunction with the da Vinci Si Surgical System before using the 8.5 mm endoscope and components. This section contains important information about the differences between the 8.5 mm and 12 mm endoscopes and components. WARNING: Be sure to read and understand all caution and warning information found in this manual before using this product. Indications for Use The Intuitive Surgical 8.5 mm Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical da Vinci Si Instrument Control System during laparoscopic and thoracoscopic surgical procedures. F.1 Overview 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL The 8.5 mm endoscope provides a 3D view of the operative field when used with the da Vinci Si High Definition Vision System. The small diameter of the 8.5 mm endoscope enables the da Vinci Si Surgical System to be used with a smaller endoscope port. While the system is not docked, you can use the 8.5 mm endoscope for laparoscopy through a da Vinci 8 mm instrument cannula. Figure F.1 Using the 8.5 mm endoscope manually da Vinci® Si™ Appendix F: 8.5 mm Endoscope for the da Vinci Si System The 8.5 mm endoscope uses a three-piece system concept (endoscope, adapter and camera). The 8.5 mm endoscope is compatible with the High Definition cameras, illuminators and light guides provided with the da Vinci Si Surgical System. The 8.5 mm endoscope is available in straight (0°) and angled (30°) tip configurations. • While the system is docked, the 8.5 mm endoscope requires use of the 8.5 mm Endoscope Cannula or a validated third-party endoscope cannula. Refer to the list of Validated 3rd Party Products for da Vinci® Surgical Systems (PN 871770). • The 8.5 mm endoscope requires use of the 8.5 mm Alignment Target. • The 8.5 mm endoscope is approximately 90 mm shorter than the 12 mm endoscope. • The 8.5 mm endoscope tip is not heated. • The 8.5 mm endoscope is more flexible than the 12 mm endoscope. Therefore, special care in the setup and handling of the 8.5 mm endoscope is required. • To prevent damage during reprocessing, we strongly recommend you place the endoscope in a properly designed sterilization tray or case, like those we identify in the list of Suggested 3rd Party Products for da Vinci® Surgical Systems (PN 871771) • The 8.5 mm endoscope has lower resolution and less brightness than the 12 mm endoscope. CAUTION: The 8.5 mm endoscope should only be used in cases where the image quality of the 12 mm endoscope is not required. A 12 mm endoscope should be available for use if an increase in image quality is preferred. F.2 Working with the 8.5 mm Endoscope 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Special considerations for the 8.5 mm endoscope include: The 8.5 mm endoscope uses the same camera arm and camera head drapes as the 12 mm endoscope. However, the 8.5 mm endoscope requires a specific alignment target and endoscope cannula. The 8.5 mm endoscope, alignment target and cannulae are clearly marked “8.5 mm” (see Figure F.2 for examples below). Figure F.2 “8.5 mm” marking on alignment target and endoscope The following table provides the compatible combinations of reusable cannula, cannula mount and alignment target for use with the 8.5 mm endoscope on da Vinci Si Surgical Systems. For a list of disposable endoscope cannulae validated by Intuitive Surgical, refer to the list of Validated 3rd Party Products for da Vinci® Surgical Systems (PN 871770). da Vinci® Si™ F-2 F-3 Appendix F: 8.5 mm Endoscope for the da Vinci Si System Alignment Target Endoscope Cannula Mount Reusable Endoscope Cannula 371679 371521 (ETH/TAUT) 420260 Refer to appropriate sections of this user manual for general instructions regarding endoscope alignment and setup, including connections to the other components of the Vision System and to the camera arm of the Patient Cart. Refer to the Reprocessing Instructions for compatible sterilization methods and parameters for the 8.5 mm endoscopes. ________________________________End of section________________________________ 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Table F-1 Compatible combinations of reusable cannula da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference G Appendix G: Symbols, Icons and Text G.1 Overview This appendix provides a reference for symbols, LEDs (colored lights), icons and text messages you may see on system components or monitors. Symbols Symbols appear on system components and serve these purposes: • Identification of important system connections and functions • Provide caution and warning information LED Status Indicators Indications of the status of the instrument and camera arms are provided by LEDs on the top of the insertion axis of each instrument and camera arm. The meanings of the colors are as follows: LED Quick Reference Not ready for surgeon control blinking Arm or port clutch blinking Guided tool change 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Messages Reference Ready for surgeon control Warning: Intervention required See display for details Error: System restart required See display for details blinking System working. Please wait. Figure G.1 LED Quick Reference Corresponding LED icons—graphics that reproduce the LED status—appear simultaneously on the touchscreen and stereo viewer. da Vinci® Si™ G-1 G-2 Appendix G: Symbols, Icons and Text Messages Reference On-Screen Icons and Text Messages Other console instrument status area/icon Camera indicators: angle, rotation, zoom Modal message area Critical message area/icon Arm 2 status: on left, active (larger) Arm 1 status: on right, active (larger) Arm 3 status: on left inactive (smaller, below, gray) Left master message area/icon Right master message area/icon Camera arm message area/icon 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Icons and text messages are overlaid on the video displays to provide information regarding the status of the system. The following figures illustrate arrangement of overlaid elements in the stereo viewer and touchscreen displays. Note that many overlaid elements appear only when needed, and others are usually or always present. Inactive instrument name (gray) Active instrument arm message areas/icons Footswitch map Active instrument Inactive instrument name arm message area/icon Figure G.2 Stereo viewer display (SmartPedal technology) da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Critical message area/icon Modal message area Arm 1 data: on right, instrument name, energized (bolt), foot over enabled pedal pair (blue) Instrument arm message areas, icons Menu pop up area Camera message area, icon Camera angle, zoom, rotation indicator Menu tabs area Figure G.3 Touchscreen display G.2 Symbols and Icons Reference Table Table G-1 Symbols and Icons 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Arm 2 data: on left, surgeon name or console control Single or dual console masters & instruments status Symbol or Icon Meaning Where Found Read the operating instructions. System component labels Type CF Applied Part On camera head and instruments Type BF Applied Part On Illuminator. Note: The da Vinci Si camera head provides isolation in accordance with a CF applied part and is acceptable for use with the Y1903 Illuminator. Illuminator lamp module or Caution: Hot da Vinci® Si™ G-3 G-4 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Vision Setup button Inside (not visible to users) the Camera Control Unit, Core, Vision Cart, Patient Cart and Surgeon Console Camera head Focus In, Focus Out buttons Camera head Lamp On/Off button Camera head Flush Port On instruments adjacent to flush port 30 degrees up, indicates which side On one side of endoscope base of scope should be on same side as camera head buttons to achieve this scope orientation. 30 degrees down, indicates which On one side of endoscope base side of scope should be on same side as camera head buttons to achieve this scope orientation. Turn as indicated to unlock. Camera head and endoscope 30º 30º 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Protective ground Where Found Turn as indicated to lock. da Vinci® Si™ Camera head and endoscope Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found Do not autoclave. Endoscope and camera head Fragile, handle with care Endoscope Ethernet Connection Inside Surgeon Console service panel and rear of Patient Cart Alternating Current On product labels containing rating information on rear of Patient Cart, Surgeon Console and Vision Cart Rear of Surgeon Console, Patient Cart, Vision Cart, Camera Control Unit, Illuminator and Core. Note: The terminal is not required for operation. It is provided for convenience to allow for other equipment to be at the same equalization potential as the da Vinci Surgical System. Inside Surgeon Console service panel and rear of Patient Cart Autoclave Equipotential Terminal 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon Serial Port Connection Standby—found on Power buttons of Vision Cart, Patient Cart and Surgeon Console, lit amber when in standby mode (connected to mains but not powered on), blue when powered on. Off (power: disconnection from mains) Power buttons on Patient Cart, Vision Cart, Surgeon Console and Core On (power: connection to mains) Rear of Patient Cart, Vision Cart and Surgeon Console, Illuminator, Camera Control Unit and Core Back of Core and back of Surgeon Console DVI video port DVI da Vinci® Si™ Rear of Patient Cart, Vision Cart and Surgeon Console, Illuminator, Camera Control Unit and Core G-5 G-6 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Composite video ports S-Video port Composite S-Video Core Video port Illuminator control ports Back of CCU Core control ports Back of CCU Audio bay, green Audio Left Right Core Video Illuminator Control Core Control Video Control Touch Screen Where Found Back of Core Back of Core and back of Surgeon Console Back of Core and back of Surgeon Console Back of Core and back of Surgeon Console Back of Core and back of Surgeon Console Back of Core and back of Surgeon Console Back of Core and back of CCU SDI video port SDI Video control ports Back of Core Touchscreen audio connection port Back of Core Audio Touchscreen video connection ports Touch Screen 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Meaning Back of Core Video Touchscreen communication ports Back of Core Touch Screen Com Service connection ports Headset connection port Back of Core Back of Core and back of Surgeon Console Audio line in port Back of Core and back of Surgeon Console Audio line out port Back of Core and back of Surgeon Console Video out bay, orange, labeled Back of Core and back of Surgeon either “Aux” for auxiliary (on Core); Console L (left) and R (right) (on Surgeon Console); or 1 and 2 (optional bays on Core) Video in bay, blue Back of Core and back of Surgeon Console SERVICE Headset Line In Line Out Video Out TilePro Input da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon FIBER PUSH 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL BRAKE Meaning Where Found Fiber cable (system cable) receptacle Indicates the brakes on the Surgeon Console, applied by stepping down. Indicates where to push the Surgeon Console. Master clutch Next to fiber cable receptacles on back of Core Both sides of Surgeon Console, near floor Both sides of Surgeon Console, near handles Clutch pedal on footswitch panel Instrument arm swap Arm swap kick-plate (left side) on footswitch panel Do not step here. On Patient Cart base Tip hazard during transport. Stow touchscreen and close rear door before moving cart. On label on rear door of Vision Cart Do not move Surgeon Console from Back of Surgeon Console the back. Dispose of in accordance with local System labels regulations—particularly applies to electronic components. da Vinci® Si™ G-7 G-8 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found Fiber cable (system cable) receptacle Next to system cable receptacles on back of Core, Surgeon Console and Patient Cart Caution: Laser hazard On blue covers of system cable receptacles on Core, Surgeon Console and Patient Cart Video output format of associated Back of Core, with connection bays output ports is configurable via the touchscreen. On Video Settings tab, select Video Output button. Energy activation cable connection Back of Core port 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon da Vinci® Si™ Video out bay, left video channel; video has no overlays. This is component video, made up of Y (green port), PR (red port) and PB (blue port). A similar label appears for the right video channel. Surgeon head-in sensor Back of Camera Control Unit (CCU) Indicates forward and reverse for the Patient Cart motor drive Right tiller handle Indicates range of speed for the Patient Cart motor drive Right tiller handle Surgeon Console viewer Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Where Found Shows use of throttle Between the tiller handles Explains N=Neutral and D=Drive positions for the motor drive shift switches. Includes text, “IF NO CART POWER, USE NEUTRAL TO MOVE CART” Top of Patient Cart motor drive tiller. Camera Arm setup joint “Sweet Spot” label: Its limits indicate recommended distance range of Camera Arm remote center from Patient Cart tower 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Shows use of throttle enable switch Between the tiller handles da Vinci® Si™ “Drive” position: Patient Cart drive motor engaged Patient Cart base near motor shift switches “Neutral” position: Patient Cart drive motor disengaged Patient Cart base near motor shift switches Brake release Near upper port clutch button on instrument and camera arms G-9 G-10 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found Pinch/Crush Hazard On Patient Cart, below upper port clutch button and at junction of setup joint and top of column on instrument and camera arms; on Surgeon Console Emergency Power Off Rear of Patient Cart Not used on IS3000 system but may Interference may occur in the vicinity of equipment marked with appear on other equipment in the this symbol. OR Speaker connection port Back of Core Microphone connection port Back of Core Critical message area The system is preparing to shut down. A message indicating the number of seconds until shut down appears in the body text area. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon General information icon. Appears Critical message area when the system is providing information that is not fault-related. Camera arm message area General warning / recoverable fault. Critical message area Appears when the system detects a recoverable fault somewhere Touchpad popup dialog within the system not associated with a particular arm or master. Touchpad error handling area da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning General critical warning / non-recoverable fault. Appears when the system detects a non-recoverable fault somewhere within the system not associated with a particular arm or master. Where Found Critical message area Touchpad error handling area Can also appear by itself on the touchscreen and touchpad when a critical startup error has occurred Scope not detected. Appears when Critical message area the system does not detect an endoscope and the user is Touchpad popup dialog attempting to go into following. Guided tool change in progress Instrument arm message area The system has detected a problem Instrument arm message area with the instrument. This can appear when the instrument is expired, when the instrument is incompatible with the system, when the system is not prepared to have an instrument installed on it, or when the system is having difficulty communicating with the instrument. General informational icon related Instrument arm message area to the instrument. This can appear when the system is downloading new instrument information from a plug-and-play instrument. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon Camera arm message area Camera arm is currently clutched and is free to be moved by OR staff around its remote center. da Vinci® Si™ G-11 G-12 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Where Found The system has detected a non-recoverable fault on the left master. Left master message area The system has detected a non-recoverable fault on the right master. Right master message area The system has detected a non-recoverable fault on an instrument arm. Instrument arm message area The system has detected a non-recoverable fault on the camera arm. Camera arm message area Move the right master grips to match the instrument grips (i.e., “Follow on matching grip”). Right master message area 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Instrument arm is currently Instrument arm message area clutched and is free to be moved by OR staff around its remote center. da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Where Found The system has detected a recoverable fault or other resolvable problem on the left master. Left master message area The system has detected a recoverable fault or other resolvable problem on the right master. Right master message area The system has detected a recoverable fault or other resolvable problem on an instrument arm. Instrument arm message area 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Move the left master grips to match Left master message area the instrument grips (i.e., “Follow on matching grip”). The system has detected a Camera arm message area recoverable fault or other resolvable problem on the camera Above footswitch map when arm. camera control pedal is pressed on other console. In dual console mode, appears when camera control pedal is pressed on other console, explaining why instruments stop moving and firing. The instrument tip is still inside the Instrument arm message area cannula. To continue, you must clutch the instrument arm and advance the tip into the body. da Vinci® Si™ G-13 G-14 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found The system has detected excessive Instrument arm message area force on an instrument arm. This normally means that some external object is pushing on an arm. This instrument arm is locked; unlock it via the touchpad to use. Instrument arm message area Hit the arm swap pedal to use the instrument in question. Instrument arm message area The system has detected a problem Instrument arm message area with a cannula. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon Relax your grip on the left master so Left master message area that it can self-align. Relax your grip on the right master Right master message area so that it can self-align da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Where Found Roll the right master grip to proceed. Right master message area Your instruments have been Critical message area reassigned. Tap ‘Arm Swap’ pedal to acknowledge and continue. Touchscreen instrument arm status area Dual console instrument status area (touchpad and touchscreen) The instrument arm is conducting its self test. Instrument arm message area The camera arm is conducting its self test. Camera arm message area 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Roll the left master grip to proceed. Left master message area The left master is conducting its self Left master message area test. da Vinci® Si™ G-15 G-16 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found The right master is conducting its self test. Right master message area Select the desired motion scaling level. Touchpad popup menu The ergonomic settings are being adjusted. Critical message area Setup arm has been moved Instrument or camera arm message unexpectedly; press one of the port area clutch buttons to continue. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon Energy activation is currently unavailable. Energy may be unavailable because the instrument installed is not an energy instrument or because no compatible ESU for the installed instrument is detected. Energy activation is currently available. Touchscreen instrument arm status area 3D viewer instrument arm status area Touchscreen instrument arm status area 3D viewer instrument arm status area da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found No scope is detected. Touchscreen camera status area Scope detected. This icon is Touchpad central column on main page (shown vertically) Touchscreen camera status area Touchpad central column on main page (shown vertically) accompanied by 30˚ , 30˚ , or 0˚. Digital Zoom. This icon is accompanied by one of the following zoom levels: • • • • Touchscreen camera status area. Touchpad central column on main page Wide Full 2x 4x Indicates which manipulator is currently associated with the surgeon’s right hand. Touchscreen instrument arm status area Touchpad instrument arm status area Indicates which manipulator is currently associated with the surgeon’s left hand. Touchscreen instrument arm status area Touchpad instrument arm status area Indicates TilePro input 1. Button on touchscreen display Indicates TilePro input 2. Button on touchscreen display 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon da Vinci® Si™ G-17 G-18 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Button on touchscreen display (for selecting endoscopic camera view) Camera control foot pedal Surgeon Console Touchscreen master status area (shown when Surgeon Console is in camera control) Button on touchscreen display (for selecting “surgeon’s TilePro view”) Electronic brightness control (does Touchscreen and touchpad displays not affect Illuminator light output). 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Camera Where Found Increase setting. Touchscreen display buttons; can be used as an alternative to sliders Decrease setting. Touchscreen display buttons; can be used as an alternative to sliders Close tab menu. Touchscreen display; used to close the tab menu Mute microphone. Touchscreen and touchpad displays; used to mute the local microphone (touchpad version mutes the Surgeon Console microphone and touchscreen version mutes the Vision Cart microphone) Touchscreen and touchpad displays; used to enable the local microphone (touchpad version enables the Surgeon Console microphone and touchscreen version enables the Vision Cart microphone) Enable microphone. da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found Speaker volume Touchscreen and touchpad displays; labels the slider that controls the local speaker volume Erase telestration marks. Touchscreen display Instrument arm locked (when on screen). Instrument arm message area on touchscreen. Brake applied (when brake pedal is Touchpad instrument arm lock depressed on Surgeon Console). button Adjust right. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon da Vinci® Si™ Above applied brakes on Surgeon Console Touchscreen / touchpad displays for camera calibration Adjust left. Touchscreen / touchpad displays for camera calibration Adjust up. Touchscreen / touchpad displays for camera calibration Adjust down. Touchscreen / touchpad displays for camera calibration Secondary Energy Pedal 3D viewer footswitch map G-19 G-20 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found Secondary Energy Pedal (when pressed) 3D viewer footswitch map Primary Energy Pedal 3D viewer footswitch map Primary Energy Pedal (when pressed) 3D viewer footswitch map Arm Swap Pedal 3D viewer footswitch map Arm Swap Pedal (when pressed) 3D viewer footswitch map Master Clutch Pedal 3D viewer footswitch map 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning Where Found 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Master Clutch Pedal (when pressed) 3D viewer footswitch map Camera Control Pedal 3D viewer footswitch map Camera Control Pedal (when pressed) 3D viewer footswitch map Masters status 3D viewer footswitch map Masters status: left finger clutch activated 3D viewer footswitch map Masters status: right finger clutch activated) 3D viewer footswitch map 3D viewer footswitch map Masters status during camera control: indicates that roll-to-focus is available 3D viewer footswitch map Masters status during camera control, when master roll is causing camera to focus in the + direction 3D viewer footswitch map Master controls status during camera control, when master roll is causing camera to focus in the – direction) da Vinci® Si™ G-21 G-22 Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Symbol or Icon Meaning 3D viewer (top center) Touchscreen (lower right) 3D viewer (top center) Camera rotation indicator when Touchscreen (lower right) angle is indeterminate; this can happen when no scope is selected or when scope is looking straight up or straight down. Touchscreen masters & instruments Left and right master are not associated with an instrument arm. status area (top center) Left master is associated with an instrument on arm 2 and right master is associated with an instrument on arm 1. Cautery instrument on arm 1 with right master is not energized for some reason. 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Camera rotation indicator Where Found 3D viewer (upper left) in dual console mode Touchscreen masters & instruments status area (top center) 3D viewer (upper left) in dual console mode Touchscreen masters & instruments status area (top center) 3D viewer (upper left) in dual console mode Energized instrument on arm 1 with Touchscreen masters & instruments right master is locked. status area (top center) 3D viewer (upper left) in dual console mode There is a problem with the cannula Touchscreen masters & instruments status area (top center) on arm 1 with the right master. 3D viewer (upper left) in dual console mode The instrument on arm 1 with right Touchscreen masters & instruments status area (top center) master is experiencing excessive external force. 3D viewer (upper left) in dual console mode da Vinci® Si™ Appendix G: Symbols, Icons and Text Messages Reference Table G-1 Symbols and Icons Meaning Where Found System reports “No instrument Touchscreen masters & instruments installed” on instrument arm 1 with status area (top center) right master. 3D viewer (upper left) in dual console mode Right master is finger clutched. Touchscreen masters & instruments status area (top center) Recoverable problem with right master. Instrument arm 1 clutched. 3D viewer (upper left) in dual console mode Touchscreen masters & instruments status area (top center) 3D viewer (upper left) in dual console mode Touchscreen masters & instruments status area (top center) da Vinci Network Offline. 3D viewer (upper left) in dual console mode Touchscreen lower right da Vinci Network Online. Touchscreen lower right OnSite Session In Progress. Touchscreen lower right 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL Symbol or Icon da Vinci® Si™ G-23 G-24 Appendix G: Symbols, Icons and Text Messages Reference Table G-2 contains a list of text messages that can appear on screen, sorted alphabetically. The text messages can appear in one or several contexts and locations and are written so as to be understood in each context on screen, and therefore not explained further. Variables are shown in italics inside angled brackets, like this:. This table is provided as a reference and to support translation into languages not supported in the system software. Table G-2 Text Messages Message 10/9/14 DRAFT/PRE-RELEASE/CONFIDENTIAL G.3 Text Messages Reference Table # A B C P1 P2 P3 P4
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.5 Linearized : No Author : cynthiag Create Date : 2015:04:29 15:41:39-07:00 Modify Date : 2015:04:29 15:44:03-07:00 Tagged PDF : Yes XMP Toolkit : Adobe XMP Core 4.2.1-c043 52.372728, 2009/01/18-15:08:04 Metadata Date : 2015:04:29 15:44:03-07:00 Creator Tool : FrameMaker 11.0.2 Format : application/pdf Title : da Vinci Si User Manual.book Creator : cynthiag Document ID : uuid:6a216d88-fa85-4245-aef9-c15c3cdacef7 Instance ID : uuid:7f58aa17-2d45-45b3-b370-850733c4ef12 Producer : Acrobat Distiller 11.0 (Windows) Page Count : 100EXIF Metadata provided by EXIF.tools