Boston Scientific (Master Brand User’s ManualTemplate 8.5in x 11in, 91006665 AE), User Manual, MB, SpyGlass DS Digital Controller, Global, 50511978-01B_pretrans
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
5
• Do not use the controller in the presence of flammable fluids and gases such as alcohol or oxygen. Doing
so can result in fire and burns to the operator and patient.
• The LEDs in the catheter cable receptacle remain hot for a period of time after use. To prevent burns, do
not insert fingers into catheter cable receptacle.
• Do not perform diagnostic or therapeutic procedures without a clear and adequate video display. Doing
so can result in adverse events.
• Placing the controller where other electrical medical devices can degrade the video image can delay
the procedure and result in adverse events. In addition, placing the controller where it can degrade the
performance of other equipment in the endoscopy suite due to EMI emissions can delay the procedure
or result in adverse events. To ensure the controller displays a clear and adequate video image and does
not degrade the performance of other equipment, locate the controller as described in Table 6, Table
7, Table 8, and Table 9 in the Appendices. Verify operation in the endoscopy suite environment before
starting a procedure. Follow ancillary equipment directions for use to locate ancillary equipment.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
• Using a controller without disinfecting the cabinet and front panel buttons can expose the operator to
biohazardous materials. To prevent exposure to biohazardous materials, disinfect the chassis between
use using the cleaning procedure described in “Cleaning and Disinfection.”
• If the controller is connected to an improperly grounded power supply, electrical leakage can result in
electrical shock to the user. To avoid risk of electrical shock, this equipment must only be connected to a
supply mains with protective earth.
• Do not touch connecting devices for electrical connections between the different components (such
as signal input and output connections for video signals, data exchange, control circuits, etc.) and the
patient at the same time. Doing so can result in electric shock to the patient.
• If the controller experiences an unintended shutdown or lock up during a procedure, follow the procedure
described in “Recovering from a Controller Failure.” Failure to follow this recovery procedure after a controller
failure can result in patient injury.
• No modification of this equipment is allowed.
• The use of accessories and cables other than those specified or supplied as spare parts from Boston
Scientific may result in increased emissions or decreased immunity of the controller or SpyGlass™ DS System.
• Components added to the SpyGlass DS System by the user must be certified to the respective IEC
standards (IEC 60601-1 for medical equipment, IEC 60950 for data processing equipment, and IEC 60065
for A/V equipment). In addition, the user must ensure the new configuration complies with the IEC 60601-1
system standard. Power cords must be compliant with the system, and a compliant spare power cable is
provided in the power cable pack (M00546250) for this purpose.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the SpyGlass DS System, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
PRECAUTIONS
• If you block the controller’s ventilation outlet, the controller can overheat, resulting in a thermal shutdown
or equipment damage. Leave at least 12.7 mm (0.5 in) between the controller back panel and other objects
and 12.7 mm (0.5 in) of space between the side panels and other objects. Use the controller on a dedicated
equipment cart such as the SpyGlass Components Travel Cart to ensure proper ventilation.
• Spilling liquids on the controller can damage it or cause it to shut down. Do not place liquids above or
near the controller.
