Boston Scientific

EXALT Controller System

EXALT Controller Users Manual Rev A Dec 2019

Users Manual

8 Pages

in increased emissions or decreased immunity of the Controller or single-use endoscope.  Electrical Specifications  2019-12 < en >  50866131-01 Rev. A  EXALT™ Controller User’s Manual  Input voltage  100 to 240 VAC, 50/60 Hz  Rated current  1A-0.5A  Fuse rating  250 V, 2A, Type F (F2AH250V)  Power Cord Specifications 115 VAC Domestic (US)  Length-3.1 meters (10 feet) Voltage Rating-125 VAC Current Rating-10 amps Connector Type-IEC 60320 C13  250 VAC International:  Length-2.5 meters (8.2 feet) Voltage Rating-250 VAC Current Rating-10 amps Connector Type-IEC 60320 C13  ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.  Physical Specifications  • Components connected to the EXALT™ Controller 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 standard. • Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the Controller, single-use endoscope, or ancillary equipment, 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.  Height  11.5 cm (4.5 in)  INTRODUCTION  Width  33.0 cm (13.0 in)  This user manual describes how to appropriately and safely use, maintain, and troubleshoot the EXALT Controller (hereafter called the Controller).  Depth  39.5 cm (15.5 in)  • Do not connect the output of any equipment to the Controller’s video outputs.  Weight (unpackaged)  6.4 kg (14 lb)  • For hospital use only.  The Controller is used with a Boston Scientific single-use endoscope. Refer to “EXALT Controller Compatibility” for compatible Boston Scientific single-use endoscopes. Where to Get Help For technical support, ordering, service, and return authorization, contact Boston Scientific at 800-949-6708.  INTENDED USE/INDICATIONS FOR USE  PRECAUTIONS  The EXALT™ Controller is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observation.  • Blocking the Controller’s ventilation outlet can cause the Controller to 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. The Controller may be used on a dedicated equipment cart to ensure proper ventilation.  CONTRAINDICATIONS None known.  DEVICE DESCRIPTION The Controller is an electronic device that: • Receives video signals from a Boston Scientific single-use endoscope, • Processes the video signals, • Outputs video images to a video monitor, and • Outputs electrical signal(s) that interface with external image capture systems. The Controller also controls the light transmitted by the tip of the single-use endoscope to illuminate the area of interest within the anatomy. Buttons on the Controller’s front panel enable the user to control the brightness level of the light. To use the Controller, connect it to a video monitor with a video cable and then connect a Boston Scientific single-use endoscope to the Controller. The Controller provides direct visualization during an endoscopic procedure. The Controller interfaces with external media capture equipment via the Controller’s rear panel connectors. Image capture is initiated via a button on the Boston Scientific single-use endoscope. The Controller sends a signal to the video monitor notifying the user that an image capture has been initiated. User Information The Controller and these instructions are intended for use by physicians trained in endoscopic procedures. A thorough understanding of the techniques, principles, clinical applications and risks associated with endoscopic procedures is required before using the Controller with the single-use endoscope. Contents • One (1) EXALT Controller • For M00542430 – One (1) North American Power Cable • For M00542460 – One (1) EU Power Cable & One (1) Brazil Power Cable • One (1) 2.0-meter DVI cable • One (1) 2.0-meter HDMI cable Ensure the package contains the components listed above. Model Numbers EXALT Controller  M00542430  EXALT Controller (Alt-Language)  M00542460  WARNINGS • Read this user manual, the single-use endoscope directions for use, the monitor user manual, and any external media capture device user manuals before using the Controller. Failure to follow any instructions or failure to heed any warnings or precautions may result in harm or injury to patient. • 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. • 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 cleaning the cabinet and front panel buttons can expose the operator to biohazardous materials. To prevent exposure to biohazardous materials, clean the cabinet between uses, following the procedure described in “Cleaning.” • 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  • Spilling liquids on the Controller can damage it or cause it to shut down. Do not place liquids above or near the Controller. • Opening the cabinet for repair purposes can damage the Controller. The Controller does not use operatorserviceable components. To prevent damage, do not access the Controller cabinet. • Connecting an incompatible single-use endoscope to the Controller can damage the Controller. Only connect a single-use endoscope listed in the “EXALT Controller Compatibility” section. • Locate the Controller appropriately to avoid accidentally pulling cable connections, which can result in disconnection and loss of visualization. • Before starting a procedure, ensure components such as the monitor and irrigation pump that support the EXALT Controller and single-use endoscope are present and operational. Starting a procedure without the supporting components present and operational can prolong the procedure. • Do not use cleaning solutions that contain long-life surfactants. Doing so can leave conductive residues on the contacts of the single-use endoscope connector receptacle. The conductive residues can lead to malfunctions of the Controller. • Use of a cardiac defibrillator while a connected singleuse endoscope remains in a patient can damage the Controller. To prevent damage to the Controller when using a defibrillator, remove the single-use endoscope before using the defibrillator. • Do not insert a wet connector into the Controller receptacle as poor video performance or damage to the Controller may result. • Applied parts of other electrical medical equipment in application with this equipment have to be type BF. Hence, only connect a single-use endoscope listed in the “EXALT Controller Compatibility” section. ADVERSE EVENTS Please refer to single-use endoscope DFU. CONFORMANCE TO STANDARDS Essential Performance Statement Per IEC 60601-1, the Controller does not have any functions that would present an unacceptable risk if failure occurred. HOW SUPPLIED Device supplied non-sterile. Inspect the Controller and cables for damage. Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible. Do not use a component if it appears damaged.  Black (K) ∆E ≤5.0  Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A  Specifications
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