E-1 Appendix E System Specifications Contents E.1 Design Life . E-1 E.2 Power Requirements Main Components . E-1 E.3 Power Specifications Main Components . E-4 E.4 Power Specifications Tower Components . E-5 E.5 Power Specifications Integrated Equipment . E-5 E.6 Laser Specifications Robot . E-6 E.7 Physical Dimensions . E-6 E.8 Environmental Specifications . E-7 E.9 Crate Dimensions . E-7 E.10 Electromagnetic Compatibility. E-7 E.11 Wireless Communication . E-16 E.1 Design Life The system has a design life of 5 years. However, even after 5 years, the standard maintenance contract provides preventive maintenance, inspection, and re-qualification by Intuitive personnel that extends the service life of the system until the next scheduled service, which occurs at least every 2 years. E.2 Power Requirements Main Components The system has three main components requiring electrical power: the Console, the Robot, and the Tower. The integrated VIO dV electrosurgical unit also requires electrical power. To ensure optimum performance, make sure each component of the system (including the VIO dV) is connected to a dedicated, noise-free, and well-grounded AC power outlet. CAUTION: To avoid overloading circuits, all three components Tower, Robot, and Console must operate on separate, dedicated power circuits. Do not connect ancillary devices such as insufflators or energy devices on the same circuit as the system components, particularly the Tower because it has large power requirements. Ancillary devices must be connected to wall outlets on separate circuits from all system components. A label on the rear of the Tower reinforces this caution. Its text appears below the label image. Figure E.1 Tower power caution label Vision Cart requires dedicated circuit. Do not connect auxiliary equipment to the circuit powering the Vision Cart. Da Vinci IS5000 System User Manual 555500-01 Rev. A E-2 System Specifications | Power Requirements Main Components The integrated power strip in the Tower also has the label below:
Figure E.2 Tower integrated power strip caution label For Intuitive Use Only. 150 VA maximum power available from unused receptacles on the power strip. 100/120/230 V~
50/60 Hz 150 VA Continuous A label wrapped around the Tower power cord also reinforces this point:
Figure E.3 Tower power cord caution label Caution: Vision Cart requires dedicated circuit. Do not connect auxiliary equipment to the circuit powering the Vision Cart. The tables below provides dedicated circuit requirements for each component. Table E.1 Dedicated circuits required for 115 VAC, 60 cycle at 15 and 20 amperes System Component Circuit Voltage Console 1 Optional Console 2 Robot Tower Notes This circuit can be shared with other auxiliary devices such as an insufflator, third-party electrosurgical unit, video recorder, etc. VAC 115 115 115 115 115 Ampere Service 15 15 15 20a As needed 1 2 3 4 5 a. Circuit breaker for the Tower needs to be suitable for motor-transformer loads. (For example, tripping characteristic K.) Da Vinci IS5000 System User Manual 555500-01 Rev. A Robot Tower Notes Console Robot Corea, b System Specifications | Power Requirements Main Components E-3 Table E.2 Dedicated circuits required for 230 VAC, 50 cycle at 10 Y System Component Circuit Voltage Console 1 Optional Console 2 This circuit can be shared with other auxiliary devices such as an insufflator, third-party electrosurgical unit, video recorder, etc. VAC 230 230 230 230 230 Ampere Service 10 10 10 10a As needed 1 2 3 4 5 a. Circuit breaker for the Tower needs to be suitable for motor-transformer loads. (For example, tripping characteristic K.) The Console, Robot, and Tower automatically adapt to 100230 VAC. This technique is called Auto Sense (see table below). Refer to the electrical rating label located on the bottom rear panel of the system components. Table E.3 Auto sense System Component Voltage Rating 1000 VA Continuous 1200 VA Continuous 1500 VA Continuous 650 VA Continuous 100230 V~
50/60 Hz Auto Sense 100230 V~
50/60 Hz Auto Sense 100230 V~
50/60 Hz Auto Sense 100230 V~
50/60 Hz Auto Sense 100230 V~
50/60 Hz Auto Sense Tower includes Core, Endoscope Controller and AP5000 Endoscope Controllera 450 VA Continuous
(continues on next page) Da Vinci IS5000 System User Manual 555500-01 Rev. A E-4 System Specifications | Power Specifications Main Components Table E.3 Auto sense (continued) System Component Voltage Rating 100230 V~
50/60 Hz Auto Sense 175 VA Continuous AP5000a Notes a. Core, Endoscope Controller power requirements are included in the Tower. These are provided separately for reference only. b. If any of the carts in the system are to be run on voltage higher than 120 VAC in the U.S., it must be powered from a center-tapped, single phase circuit. E.3 Power Specifications Main Components Table E.4 Power specifications for main components Console Robot Tower (includes Core, AP5000, and Endo-
scope Controller) Voltage 100230 VAC 100230 VAC 100230 VAC Rating and Typical Current 50/60 Hz Auto Sense 50/60 Hz Auto Sense 50/60 Hz Auto Sense 1000 VA Continuous 1200 VA Continuous 1500 VA Continuous 8.4 A at 115 V~
4.2 A at 230 V~
7.5 A at 115 V~
3.8 A at 230 V~
Typical current in sleep mode 0.7 A at 115 V~
1.0 A at 115 V~
0.35 A at 230 V~
1.0 A at 230 V~
Typical current in sleep mode (battery charging) NA Max inrush current at 230 VAC 24.1 A Backup Power Surge Protected NA Yes 8.5 A at 115 V~
4.6 A at 230 V~
56.0 A 5 min. Yes 12 A at 115 V~
6 A at 230 V~
2.0 A at 115 V~
1.2 A at 230 V~
63.6 A NA NA No Da Vinci IS5000 System User Manual 555500-01 Rev. A System Specifications | Power Specifications Integrated Equipment E-5 E.4 Power Specifications Tower Components Table E.5 Power specifications for Tower components Core a, b Endoscope Controller AP5000 Voltage 100230 VAC 100230 VAC 100230 VAC 50/60 Hz Auto Sense 50/60 Hz Auto Sense 50/60 Hz Auto Sense Power 650 VA Continuous 450 VA Continuous 175 VA Continuous Backup Power Surge Protected NA No NA No NA No Notes reference only. a. Core power requirements are included in the Tower. These are provided separately for b. If the Core is powered separately from the Tower, it must be powered from a center-tapped, 240 V, single phase circuit. This requirement applies to the U.S. only. E.5 Power Specifications Integrated Equipment Table E.6 Power specifications for integrated equipment Insufflator Generator Voltage Power Backup Power VAC 50/60 Hz T8A / T4A VA max NA VAC 50/60 Hz T8A / T4A VA max NA Da Vinci IS5000 System User Manual 555500-01 Rev. A E-6 System Specifications | Physical Dimensions E.6 Laser Specifications Robot Table E.7 Laser classification CLASS 1 LASER PRODUCT Complies with 21 CFR 1040.10 and 1040.11 Except for deviations pursuant to laser notice No. 50 Dated June 24, 2007 Feature/Light Source Laser Class Specification Table E.8 Laser radiation and source characteristics Feature/Light Source Wavelength Specification Horizontal Laser Positioning Laser Horizontal Laser Positioning Laser Class 1 Class 1 532 nm 532 nm E.7 Physical Dimensions as per IEC 60825-1 as per IEC 60825-1 as per IEC 60825-1 as per IEC 60825-1 Table E.9 Physical dimensions Console Robot Tower Height (min.) 57 in. (145 cm) 71.5 in. (182 cm) Height (max.) 71 in. (180 cm) 98.5 in. (250.2 cm) 76 in. (193 cm) with touchscreen stowed 87.5 in. (223 cm) with touchscreen extended Width Depth Weight 38 in. (96.5 cm) 41 in. (104 cm) 27 in. (68.6 cm) 34 in. (86 cm) 60 in. (150 cm) 36.5 in. (92.7 cm) 620 lbs. (280 kg) 1900 lbs. (861 kg) 818 lbs. (371 kg) Ground Clearance 1.9 in. (48 mm) 1.9 in. (48 mm) 4 in. (10.2 cm) Da Vinci IS5000 System User Manual 555500-01 Rev. A System Specifications | Electromagnetic Compatibility E-7 E.8 Environmental Specifications Table E.10 Environmental conditions: operating Environmental Conditions: operating Temperature 10 to 30 C (50 to 86 F) Humidity 10 to 85% non-condensing Atmospheric Pressure The system shall function properly in atmospheric pressures ranging from 523 mm HG (10,000 ft.) to 774 mm HG (-500 ft.). For every 1000 feet above sea level, the 30 C operational temperature limit specified above will be reduced by 1 C. (For example, the maximum operating temperature at 5000 feet will be 25 C, and the maximum operating temperature at 10,000 feet will be 20 C.) Table E.11 Environmental conditions: storage and transport Environmental Conditions: Storage and Transport Temperature
-20 to 60 C (-4 to 140 F) Humidity 5 to 90% non-condensing Note: Storage and transport of the system are not affected by atmospheric pressure. E.9 Crate Dimensions Console Robot Tower Table E.12 Crate dimensions L x W x H Weight 70 x 50 x 87.5"
2292 lbs (1039.6 kg)
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? lbs (? kg) E.10 Electromagnetic Compatibility The system has been tested and found to be in compliance with IEC 60601-1-2:2007 or IEC 60601-1-2:2014, depending on the date of manufacture. For more information on IEC compliance, contact Intuitive Customer Service. It is intended to be used in an operating room environment and operation of the system is unaffected when used in the electromagnetic environment as specified in Tables 2 4 in the EMC Da Vinci IS5000 System User Manual 555500-01 Rev. A E-8 System Specifications | Electromagnetic Compatibility Tables section. Special precautions and installation information for the system for electromagnetic compatibility (EMC) are provided in this section. The performance of the system is unaffected when exposed to full range of electromagnetic environment as described in the IEC 60601-1-2 standard. There is no degradation of performance and therefore no risks to the patient or other devices due to Electromagnetic Interference (EMI) when used in the electromagnetic environment as specified in Tables 2 4 below in the EMC Tables section. Use only Intuitive-branded interconnection cables and accessories. Performance of cables or accessories other than those specified by Intuitive as replacement parts for internal components cannot be guaranteed. Any resulting damage to the system will not be covered under warranty. Note: Use of cables or accessories other than those specified by Intuitive may result in increased electromagnetic emissions or decreased immunity of the system. Equipment in the operating room, including the 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. WARNING: Symptoms of interference could include repeated faults, unintentional movement of arms, instruments or endoscope, loss or frozen video, loss of wireless connectivity. In the event of suspected interference from other equipment, which prevents the proper functioning of the system, contact Intuitive and/or discontinue use of the system until the problem can be remedied. Note: The system should not be used adjacent to or stacked with other equipment. However, if adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it is used. Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. FCC Compliance 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. Da Vinci IS5000 System User Manual 555500-01 Rev. A System Specifications | Electromagnetic Compatibility E-9 In regard to grounding reliability and electromagnetic interference, see the label below, which appears on the Console and Robot. Its text is repeated below the label image:
GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE This device complies with part 15 of the FCC Rules. operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Essential Performance Note: The essential performance for system during EMC testing was defined as follows during any of the required tests:
The system shall display a real-time image of the surgical site with acceptable clinical performance. If the displayed image is not live, such as when displaying a recorded image or in the event of system malfunction, it shall be obvious to the user that the displayed image is not a live image. There shall be no uncontrolled or unexpected motions of the endoscope or instrument tips. During immunity testing, the following conditions are not allowed to meet the basic safety and essential performance criteria:
Faults that cause system restart while in READY MODE HEAD IN state unless allowed by the Medical standard
Unintentional movement of the arms
Loss or frozen image where transient flicker is acceptable Persistent loss of connectivity for the Wireless Connectivity Option where loss of connectivity is acceptable if the connection can be re-established after the test. EMC Tables IEC 6060112:2007 The system has been tested and found to be in compliance with IEC 60601-1-2:2007 International standard for Medical electrical equipment Part 1-2: General requirements for basic safety and Da Vinci IS5000 System User Manual 555500-01 Rev. A